Trial Outcomes & Findings for An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT02750514)
NCT ID: NCT02750514
Last Updated: 2021-03-22
Results Overview
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
TERMINATED
PHASE2
295 participants
From first dose to 2 years following last dose (up to 30 months)
2021-03-22
Participant Flow
The total number of participants randomized and treated is 295. Each participant was assigned to 1 of 5 non-consecutive Tracks (based on previous therapy exposure and/or PD-1/PD-L1 expression). 14 of the 295 participants, after receiving initial treatment, were re-randomized to a second, different treatment (either under a different Track or within the same Track).
Participant milestones
| Measure |
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Track 1
STARTED
|
40
|
4
|
0
|
3
|
0
|
|
Track 1
COMPLETED
|
13
|
2
|
0
|
1
|
0
|
|
Track 1
NOT COMPLETED
|
27
|
2
|
0
|
2
|
0
|
|
Track 2
STARTED
|
9
|
8
|
2
|
12
|
0
|
|
Track 2
COMPLETED
|
3
|
0
|
0
|
5
|
0
|
|
Track 2
NOT COMPLETED
|
6
|
8
|
2
|
7
|
0
|
|
Track 3
STARTED
|
0
|
41
|
16
|
18
|
0
|
|
Track 3
COMPLETED
|
0
|
5
|
1
|
2
|
0
|
|
Track 3
NOT COMPLETED
|
0
|
36
|
15
|
16
|
0
|
|
Track 4
STARTED
|
0
|
53
|
0
|
60
|
0
|
|
Track 4
COMPLETED
|
0
|
2
|
0
|
18
|
0
|
|
Track 4
NOT COMPLETED
|
0
|
51
|
0
|
42
|
0
|
|
Track 5
STARTED
|
0
|
0
|
0
|
0
|
43
|
|
Track 5
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Track 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
43
|
Reasons for withdrawal
| Measure |
Nivolumab
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Track 1
Disease progression
|
20
|
1
|
0
|
1
|
0
|
|
Track 1
Adverse event unrelated to study drug
|
1
|
0
|
0
|
0
|
0
|
|
Track 1
Study drug toxicity
|
4
|
1
|
0
|
1
|
0
|
|
Track 1
Participant request to discontinue
|
1
|
0
|
0
|
0
|
0
|
|
Track 1
Other reasons
|
1
|
0
|
0
|
0
|
0
|
|
Track 2
Disease progression
|
4
|
5
|
2
|
5
|
0
|
|
Track 2
Adverse event unrelated to study drug
|
1
|
0
|
0
|
0
|
0
|
|
Track 2
Study drug toxicity
|
1
|
2
|
0
|
2
|
0
|
|
Track 2
Participant withdrew consent
|
0
|
1
|
0
|
0
|
0
|
|
Track 3
Disease progression
|
0
|
24
|
13
|
14
|
0
|
|
Track 3
Adverse event unrelated to study drug
|
0
|
1
|
1
|
1
|
0
|
|
Track 3
Study drug toxicity
|
0
|
3
|
0
|
1
|
0
|
|
Track 3
Participant request to discontinue
|
0
|
2
|
0
|
0
|
0
|
|
Track 3
Participant withdrew consent
|
0
|
3
|
1
|
0
|
0
|
|
Track 3
Other reasons
|
0
|
3
|
0
|
0
|
0
|
|
Track 4
Study drug toxicity
|
0
|
6
|
0
|
5
|
0
|
|
Track 4
Participant request to discontinue
|
0
|
1
|
0
|
1
|
0
|
|
Track 4
Participant withdrew consent
|
0
|
1
|
0
|
0
|
0
|
|
Track 4
Other reasons
|
0
|
5
|
0
|
3
|
0
|
|
Track 4
Disease progression
|
0
|
33
|
0
|
32
|
0
|
|
Track 4
Adverse event unrelated to study drug
|
0
|
5
|
0
|
0
|
0
|
|
Track 4
Death
|
0
|
0
|
0
|
1
|
0
|
|
Track 5
Disease progression
|
0
|
0
|
0
|
0
|
34
|
|
Track 5
Adverse event unrelated to study drug
|
0
|
0
|
0
|
0
|
2
|
|
Track 5
Study drug toxicity
|
0
|
0
|
0
|
0
|
2
|
|
Track 5
Participant request to discontinue
|
0
|
0
|
0
|
0
|
3
|
|
Track 5
Other reasons
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Nivolumab
n=49 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=104 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=17 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=88 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=37 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 9.25 • n=7 Participants
|
66.6 Years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 9.04 • n=4 Participants
|
63.6 Years
STANDARD_DEVIATION 7.89 • n=21 Participants
|
63.5 Years
STANDARD_DEVIATION 9.21 • n=10 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
122 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
173 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
192 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
94 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
245 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From first dose to 2 years following last dose (up to 30 months)Population: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Outcome measures
| Measure |
Nivolumab
n=49 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=106 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=18 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=93 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=43 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
Study Track 1
|
17.5 Percent of Participants
Interval 7.3 to 32.8
|
25.0 Percent of Participants
Interval 0.6 to 80.6
|
—
|
0 Percent of Participants
Interval 0.0 to 70.8
|
—
|
|
Objective Response Rate (ORR)
Study Track 2
|
0 Percent of Participants
Interval 0.0 to 33.6
|
0 Percent of Participants
Interval 0.0 to 33.6
|
0 Percent of Participants
Interval 0.0 to 84.2
|
25.0 Percent of Participants
Interval 5.5 to 57.2
|
—
|
|
Objective Response Rate (ORR)
Study Track 3
|
—
|
2.4 Percent of Participants
Interval 0.1 to 12.9
|
0 Percent of Participants
Interval 0.0 to 20.6
|
5.6 Percent of Participants
Interval 0.1 to 27.3
|
—
|
|
Objective Response Rate (ORR)
Study Track 4
|
—
|
1.9 Percent of Participants
Interval 0.0 to 10.1
|
—
|
20.0 Percent of Participants
Interval 10.8 to 32.3
|
—
|
|
Objective Response Rate (ORR)
Study Track 5
|
—
|
—
|
—
|
—
|
2.3 Percent of Participants
Interval 0.1 to 12.3
|
PRIMARY outcome
Timeframe: From first dose to 2 years following last dose (up to 30 months)Population: All participants with a confirmed best overall response (BOR) of Complete Response (CR) or Partial Response (PR).
DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Outcome measures
| Measure |
Nivolumab
n=7 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=3 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=16 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=1 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
Study Track 1
|
12.81 Months
Interval 0.0 to
Insufficient number of subjects analyzed
|
8.57 Months
Insufficient number of subjects analyzed
|
—
|
—
|
—
|
|
Duration of Response (DOR)
Study Track 2
|
—
|
—
|
—
|
NA Months
Insufficient number of subjects analyzed
|
—
|
|
Duration of Response (DOR)
Study Track 3
|
—
|
NA Months
Insufficient number of subjects analyzed
|
—
|
NA Months
Insufficient number of subjects analyzed
|
—
|
|
Duration of Response (DOR)
Study Track 4
|
—
|
NA Months
Insufficient number of subjects analyzed
|
—
|
12.65 Months
Interval 8.7 to
Insufficient number of subjects analyzed
|
—
|
|
Duration of Response (DOR)
Study Track 5
|
—
|
—
|
—
|
—
|
3.75 Months
Insufficient number of subjects analyzed
|
PRIMARY outcome
Timeframe: From first dose to 24 weeks after first dosePopulation: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (\>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (\<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track.
Outcome measures
| Measure |
Nivolumab
n=49 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=106 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=18 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=93 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=43 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Progression Free Survival Rate (PFSR) at 24 Weeks
Study Track 1
|
0.302 Proportion of Participants
Interval 0.164 to 0.451
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
—
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
—
|
|
Progression Free Survival Rate (PFSR) at 24 Weeks
Study Track 2
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
0.455 Proportion of Participants
Interval 0.167 to 0.707
|
—
|
|
Progression Free Survival Rate (PFSR) at 24 Weeks
Study Track 3
|
—
|
0.191 Proportion of Participants
Interval 0.079 to 0.34
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
—
|
|
Progression Free Survival Rate (PFSR) at 24 Weeks
Study Track 4
|
—
|
NA Proportion of Participants
Insufficient number of participants remaining progression free
|
—
|
0.391 Proportion of Participants
Interval 0.265 to 0.514
|
—
|
|
Progression Free Survival Rate (PFSR) at 24 Weeks
Study Track 5
|
—
|
—
|
—
|
—
|
0.111 Proportion of Participants
Interval 0.036 to 0.235
|
SECONDARY outcome
Timeframe: From first dose to 100 days following last dosePopulation: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame
Outcome measures
| Measure |
Nivolumab
n=49 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=106 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=18 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=93 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=43 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
|
100.0 Percent of Participants
|
100.0 Percent of Participants
|
100.0 Percent of Participants
|
98.9 Percent of Participants
|
100.0 Percent of Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days following last dosePopulation: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame
Outcome measures
| Measure |
Nivolumab
n=49 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=106 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=18 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=93 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=43 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
|
57.1 Percent of Participants
|
53.8 Percent of Participants
|
61.1 Percent of Participants
|
58.1 Percent of Participants
|
60.5 Percent of Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days following last dosePopulation: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame
Outcome measures
| Measure |
Nivolumab
n=49 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=106 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=18 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=93 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=43 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
|
14.3 Percent of Participants
|
23.6 Percent of Participants
|
5.6 Percent of Participants
|
11.8 Percent of Participants
|
14.0 Percent of Participants
|
SECONDARY outcome
Timeframe: From first dose to up to 45 months following first dosePopulation: All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for.
This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame
Outcome measures
| Measure |
Nivolumab
n=49 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=106 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=18 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=93 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=43 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Percentage of Participants Experiencing Death
|
57.1 Percent of Participants
|
55.7 Percent of Participants
|
66.7 Percent of Participants
|
46.2 Percent of Participants
|
62.8 Percent of Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days following last dose (approximately 9 months)Population: All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for.
The following measurements will be considered laboratory abnormalities for hepatic tests: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal
Outcome measures
| Measure |
Nivolumab
n=48 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=97 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=18 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=91 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=43 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
ALT OR AST > 3XULN
|
4 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
ALT OR AST > 5XULN
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
ALT OR AST > 10XULN
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
TOTAL BILIRUBIN > 2XULN
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days following last dose (approximately 9 months)Population: All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for.
The following measurements will be considered laboratory abnormalities for thyroid tests: * TSH value \> ULN and * With baseline TSH value ≤ ULN * At least one T3/T4 test value \< LLN * Low TSH \< LLN and * With baseline TSH value ≥ LLN * At least one T3/T4 test value \> ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine
Outcome measures
| Measure |
Nivolumab
n=29 Participants
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Dasatinib
n=76 Participants
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + BMS986016
n=14 Participants
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Nivolumab + Ipilimumab
n=75 Participants
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Nivolumab + BMS986205
n=35 Participants
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
|
4 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
TSH > ULN
|
9 Participants
|
16 Participants
|
3 Participants
|
24 Participants
|
9 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
TSH > ULN WITH TSH <= ULN AT BASELINE
|
6 Participants
|
9 Participants
|
1 Participants
|
17 Participants
|
6 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
TSH < LLN
|
5 Participants
|
3 Participants
|
0 Participants
|
20 Participants
|
4 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
TSH < LLN WITH TSH >= LLN AT BASELINE
|
5 Participants
|
1 Participants
|
0 Participants
|
16 Participants
|
4 Participants
|
|
Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
|
3 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
Adverse Events
Track 1 - Nivolumab
Track 1 - Nivolumab + Dasatinib
Track 1 - Nivolumab + Ipilimumab
Track 2 - Nivolumab
Track 2 - Nivolumab + Dasatinib
Track 2 - Nivolumab + BMS986016
Track 2 - Nivolumab + Ipilimumab
Track 3 - Nivolumab + Dasatinib
Track 3 - Nivolumab + BMS986016
Track 3 - Nivolumab + Ipilimumab
Track 4 - Nivolumab + Dasatinib
Track 4 - Nivolumab + Ipilimumab
Track 5 - Nivolumab + BMS986205
Serious adverse events
| Measure |
Track 1 - Nivolumab
n=40 participants at risk
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 1 - Nivolumab + Dasatinib
n=4 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 1 - Nivolumab + Ipilimumab
n=3 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 2 - Nivolumab
n=9 participants at risk
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 2 - Nivolumab + Dasatinib
n=8 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 2 - Nivolumab + BMS986016
n=2 participants at risk
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 2 - Nivolumab + Ipilimumab
n=12 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 3 - Nivolumab + Dasatinib
n=41 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 3 - Nivolumab + BMS986016
n=16 participants at risk
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 3 - Nivolumab + Ipilimumab
n=18 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 4 - Nivolumab + Dasatinib
n=53 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 4 - Nivolumab + Ipilimumab
n=60 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 5 - Nivolumab + BMS986205
n=43 participants at risk
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Cardiac tamponade
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Myocarditis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Pericardial effusion
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Vision blurred
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Visual impairment
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Euthanasia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Fatigue
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
General physical health deterioration
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Influenza like illness
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Pyrexia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Hepatobiliary disorders
Hepatitis
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Brain abscess
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Clostridium difficile colitis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Influenza
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Respiratory tract infection
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Septic shock
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood creatine phosphokinase increased
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Human chorionic gonadotropin positive
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Transaminases increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.0%
10/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.0%
9/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.8%
3/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
35.8%
19/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
26.7%
16/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
30.2%
13/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Cerebrovascular accident
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Seizure
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Confusional state
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Mental status changes
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
4/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Orthostatic hypotension
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
Other adverse events
| Measure |
Track 1 - Nivolumab
n=40 participants at risk
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 1 - Nivolumab + Dasatinib
n=4 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 1 - Nivolumab + Ipilimumab
n=3 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 2 - Nivolumab
n=9 participants at risk
Nivolumab monotherapy 240 mg Q2W administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 2 - Nivolumab + Dasatinib
n=8 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 2 - Nivolumab + BMS986016
n=2 participants at risk
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 2 - Nivolumab + Ipilimumab
n=12 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 3 - Nivolumab + Dasatinib
n=41 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 3 - Nivolumab + BMS986016
n=16 participants at risk
Nivolumab 240 mg Q2W + BMS986016 20 mg Q2W, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 3 - Nivolumab + Ipilimumab
n=18 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 4 - Nivolumab + Dasatinib
n=53 participants at risk
Nivolumab 240 mg Q2W + Dasatinib 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
Track 4 - Nivolumab + Ipilimumab
n=60 participants at risk
Nivolumab 240 mg Q2W for 12 doses + Ipilimumab 1 mg/kg Q6W for 4 doses, administered until completion of 24 weeks of study
|
Track 5 - Nivolumab + BMS986205
n=43 participants at risk
Nivolumab 480 mg Q4W + BMS986205 100 mg QD, administered until completion of 6 cycles (1 cycle=4 weeks)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Eye infection
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Influenza
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Blood and lymphatic system disorders
Anaemia
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
37.5%
3/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
3/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.6%
6/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
28.3%
15/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
10/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.0%
6/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Cardiac disorders
Tachycardia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
5/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
4/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
10.0%
6/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Cataract
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Eye pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Vision blurred
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Visual impairment
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
5/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.6%
6/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
27.8%
5/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
10.0%
6/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.0%
6/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Constipation
|
22.5%
9/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
75.0%
3/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
100.0%
3/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
3/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.0%
9/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
37.7%
20/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
30.0%
18/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
30.2%
13/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Diarrhoea
|
32.5%
13/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
4/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
4/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
19.5%
8/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
31.2%
5/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
37.7%
20/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
28.3%
17/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.6%
11/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Nausea
|
35.0%
14/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
75.0%
3/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
66.7%
2/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
3/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
4/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
3/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
39.0%
16/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.8%
3/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
4/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
41.5%
22/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
30.0%
18/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
37.2%
16/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Oesophageal mucosa erythema
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Tongue dysplasia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
8/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
37.5%
3/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
3/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
19.5%
8/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
26.4%
14/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
23.3%
14/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.6%
5/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Asthenia
|
12.5%
5/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
2/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.8%
4/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
20.8%
11/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.3%
11/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Chest discomfort
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Chest pain
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Chills
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.8%
4/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
13.2%
7/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Early satiety
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Face oedema
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Fatigue
|
40.0%
16/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
4/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
6/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
46.3%
19/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
31.2%
5/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
44.4%
8/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.9%
27/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
30/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
46.5%
20/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Influenza like illness
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Malaise
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Mucosal inflammation
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Oedema
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
2/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Oedema peripheral
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.2%
5/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.7%
7/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.3%
7/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Pain
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
General disorders
Pyrexia
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
2/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.8%
4/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.9%
10/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
10/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.6%
5/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Abscess
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Candida infection
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Conjunctivitis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Cystitis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Lung abscess
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Pneumonia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Rhinitis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
5/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
17.1%
7/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
10/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.3%
4/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Infections and infestations
Urinary tract infection
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.6%
5/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Amylase increased
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
4/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.3%
4/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood alkaline phosphatase increased
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.3%
4/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood calcium increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood creatinine increased
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Blood urea increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Body temperature increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
C-reactive protein increased
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Electrocardiogram QT prolonged
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Lipase increased
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Lymphocyte count decreased
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Transaminases increased
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Troponin T increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Weight decreased
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
2/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.6%
6/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
15.1%
8/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.3%
11/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
30.2%
13/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
Weight increased
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Investigations
White blood cell count increased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.0%
16/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
26.8%
11/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
4/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
27.8%
5/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
47.2%
25/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
28.3%
17/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
34.9%
15/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.3%
4/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
5/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
10.0%
6/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
4/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.8%
4/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.7%
7/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.6%
6/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Metabolism and nutrition disorders
Sodium retention
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
12/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
13.2%
7/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.3%
11/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.0%
6/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.5%
9/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
2/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
19.5%
8/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
4/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.3%
6/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
23.3%
14/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.6%
8/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.6%
6/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.6%
5/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
4/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.6%
5/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.8%
4/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.3%
6/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Balance disorder
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Brain oedema
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Dizziness
|
15.0%
6/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
17.1%
7/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
13.2%
7/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
15.0%
9/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Dysgeusia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.3%
6/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Headache
|
27.5%
11/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
37.5%
3/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.2%
5/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
4/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
15.1%
8/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.7%
7/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.6%
8/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Hemiparesis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Hypoaesthesia
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Neuropathy peripheral
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Paraesthesia
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Sciatica
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Nervous system disorders
Taste disorder
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Anxiety
|
15.0%
6/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.8%
4/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
17.0%
9/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
10.0%
6/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Confusional state
|
7.5%
3/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
5/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Psychiatric disorders
Insomnia
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.2%
5/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
10/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.6%
5/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Dysuria
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Nocturia
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Renal and urinary disorders
Urinary retention
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
10/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
3/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.2%
5/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
6/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
24.5%
13/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
15/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.6%
11/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
35.0%
14/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
75.0%
3/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
37.5%
3/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
17.1%
7/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
6/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
39.6%
21/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
20/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.0%
6/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
2/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.5%
5/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.2%
5/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.0%
3/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
2/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
24.4%
10/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
13.2%
7/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
50.0%
1/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
17.5%
7/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.9%
2/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
13.2%
7/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
5/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.5%
4/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
4/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.7%
4/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
6/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
33.3%
1/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
22.2%
2/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.8%
4/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
9.4%
5/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
26.7%
16/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
5/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
66.7%
2/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
2/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
17.1%
7/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
18.8%
3/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
3/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
13.2%
7/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
10/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.0%
3/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
12.5%
1/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
10.0%
6/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.5%
1/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
25.0%
1/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.8%
2/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.7%
1/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
1/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Deep vein thrombosis
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
6.2%
1/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Hot flush
|
0.00%
0/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.6%
1/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.3%
1/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
7.3%
3/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
5.7%
3/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
8.3%
5/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
14.0%
6/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/4 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/3 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
1/9 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/8 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/2 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
16.7%
2/12 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
2.4%
1/41 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
0.00%
0/16 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
11.1%
2/18 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
1.9%
1/53 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
3.3%
2/60 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
4.7%
2/43 • All cause mortality: from first dose to up to 45 months after first dose SAEs and AEs: from first dose to 100 days following last dose
Results are presented by study track. Track 1 = naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = with prior anti-PD-1/PD-L1 therapy Track 4 = naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER