Trial Outcomes & Findings for A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (NCT NCT05256381)
NCT ID: NCT05256381
Last Updated: 2025-11-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
166 participants
Primary outcome timeframe
Day 1 up to approximately 2 years and 2 months
Results posted on
2025-11-17
Participant Flow
Participant milestones
| Measure |
Non-small Cell Lung Cancer
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
8
|
12
|
12
|
55
|
39
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
8
|
12
|
12
|
55
|
39
|
Reasons for withdrawal
| Measure |
Non-small Cell Lung Cancer
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
2
|
2
|
8
|
6
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Death
|
17
|
3
|
4
|
5
|
24
|
21
|
|
Overall Study
Other, not specified
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Study terminated by sponsor
|
18
|
5
|
5
|
5
|
18
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
Metastatic Castration-resistant Prostate Cancer
n=54 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=39 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
8 Participants
n=122 Participants
|
14 Participants
n=79 Participants
|
21 Participants
n=806 Participants
|
72 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
11 Participants
n=120 Participants
|
4 Participants
n=122 Participants
|
40 Participants
n=79 Participants
|
18 Participants
n=806 Participants
|
93 Participants
n=43 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 10.43 • n=202 Participants
|
59.0 years
STANDARD_DEVIATION 18.34 • n=283 Participants
|
75.5 years
STANDARD_DEVIATION 10.95 • n=120 Participants
|
63.5 years
STANDARD_DEVIATION 11.02 • n=122 Participants
|
68.0 years
STANDARD_DEVIATION 6.57 • n=79 Participants
|
64.0 years
STANDARD_DEVIATION 11.59 • n=806 Participants
|
66.0 years
STANDARD_DEVIATION 10.90 • n=43 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
39 Participants
n=806 Participants
|
57 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
10 Participants
n=120 Participants
|
11 Participants
n=122 Participants
|
54 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
108 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
4 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
12 Participants
n=122 Participants
|
48 Participants
n=79 Participants
|
35 Participants
n=806 Participants
|
140 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
5 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
21 Participants
n=43 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
1 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=202 Participants
|
7 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
12 Participants
n=122 Participants
|
49 Participants
n=79 Participants
|
36 Participants
n=806 Participants
|
145 Participants
n=43 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
4 Participants
n=79 Participants
|
3 Participants
n=806 Participants
|
19 Participants
n=43 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=202 Participants
|
0 participants
n=283 Participants
|
0 participants
n=120 Participants
|
4 participants
n=122 Participants
|
1 participants
n=79 Participants
|
8 participants
n=806 Participants
|
19 participants
n=43 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=202 Participants
|
0 participants
n=283 Participants
|
0 participants
n=120 Participants
|
0 participants
n=122 Participants
|
2 participants
n=79 Participants
|
0 participants
n=806 Participants
|
2 participants
n=43 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=202 Participants
|
0 participants
n=283 Participants
|
0 participants
n=120 Participants
|
0 participants
n=122 Participants
|
2 participants
n=79 Participants
|
1 participants
n=806 Participants
|
4 participants
n=43 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=202 Participants
|
1 participants
n=283 Participants
|
0 participants
n=120 Participants
|
0 participants
n=122 Participants
|
2 participants
n=79 Participants
|
3 participants
n=806 Participants
|
8 participants
n=43 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=202 Participants
|
1 participants
n=283 Participants
|
0 participants
n=120 Participants
|
0 participants
n=122 Participants
|
1 participants
n=79 Participants
|
0 participants
n=806 Participants
|
2 participants
n=43 Participants
|
|
Region of Enrollment
Italy
|
4 participants
n=202 Participants
|
0 participants
n=283 Participants
|
2 participants
n=120 Participants
|
0 participants
n=122 Participants
|
2 participants
n=79 Participants
|
0 participants
n=806 Participants
|
8 participants
n=43 Participants
|
|
Region of Enrollment
Georgia
|
13 participants
n=202 Participants
|
4 participants
n=283 Participants
|
6 participants
n=120 Participants
|
8 participants
n=122 Participants
|
19 participants
n=79 Participants
|
6 participants
n=806 Participants
|
56 participants
n=43 Participants
|
|
Region of Enrollment
France
|
8 participants
n=202 Participants
|
1 participants
n=283 Participants
|
3 participants
n=120 Participants
|
0 participants
n=122 Participants
|
4 participants
n=79 Participants
|
5 participants
n=806 Participants
|
21 participants
n=43 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=202 Participants
|
1 participants
n=283 Participants
|
1 participants
n=120 Participants
|
0 participants
n=122 Participants
|
21 participants
n=79 Participants
|
16 participants
n=806 Participants
|
45 participants
n=43 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
11.4 percentage of participants
Interval 3.2 to 26.7
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
0 percentage of participants
Interval 0.0 to 28.5
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=54 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=39 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With a Treatment-emergent Adverse Event
|
54 Participants
|
39 Participants
|
40 Participants
|
8 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=54 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=39 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With an Adverse Event of Special Interest
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
11.4 percentage of participants
Interval 3.2 to 26.7
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
0 percentage of participants
Interval 0.0 to 28.5
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to RECIST 1.1: Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to RECIST 1.1: Partial Response
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to RECIST 1.1: Stable Disease
|
14 Participants
|
4 Participants
|
12 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to RECIST 1.1: Progressive Disease
|
18 Participants
|
23 Participants
|
20 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to iRECIST: Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to iRECIST: Partial Response
|
5 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to iRECIST: Stable Disease
|
15 Participants
|
4 Participants
|
15 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to iRECIST: Unconfirmed Progressive Disease
|
14 Participants
|
15 Participants
|
13 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsPopulation: All patients exposed to the combination therapy for at least one treatment cycle. This is defined as patients with 4 doses of SOT101 and 1 dose of pembrolizumab in Cycle 1, or patients exposed to both SOT101 and pembrolizumab in Cycle 1 who started Cycle 2. Only patients with measurable disease at baseline were included.
Outcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Best Overall Response According to iRECIST: Confirmed Progressive Disease
|
2 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Duration of Response According to RECIST 1.1
|
NA months
Interval 4.3 to
Insufficient number of participants with events
|
3.0 months
Interval 2.8 to
Insufficient number of participants with events
|
3.6 months
Interval 1.7 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
NA months
Interval 2.8 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Duration of Response According to iRECIST
|
13.9 months
Interval 4.3 to
Insufficient number of participants with events
|
3.0 months
Interval 2.8 to
Insufficient number of participants with events
|
3.6 months
Interval 1.7 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
NA months
Interval 2.8 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Clinical Benefit Rate According to RECIST 1.1
|
45.0 percentage of participants
Interval 29.3 to 61.5
|
22.9 percentage of participants
Interval 10.4 to 40.1
|
35.9 percentage of participants
Interval 21.2 to 52.8
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Clinical Benefit Rate According to iRECIST
|
50.0 percentage of participants
Interval 33.8 to 66.2
|
22.9 percentage of participants
Interval 10.4 to 40.1
|
46.2 percentage of participants
Interval 30.1 to 62.8
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
54.5 percentage of participants
Interval 23.4 to 83.3
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Progression-free Survival According to RECIST 1.1
|
2.6 months
Interval 1.4 to 6.4
|
1.6 months
Interval 1.4 to 2.6
|
1.6 months
Interval 1.3 to 2.8
|
NA months
Interval 1.1 to
Insufficient number of participants with events
|
1.4 months
Interval 1.2 to
Insufficient number of participants with events
|
2.7 months
Interval 1.1 to 4.3
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Progression-free Survival According to iRECIST
|
4.6 months
Interval 1.6 to 6.8
|
1.6 months
Interval 1.4 to 2.6
|
3.0 months
Interval 1.3 to 5.7
|
NA months
Interval 1.1 to
Insufficient number of participants with events
|
4.1 months
Interval 1.2 to
Insufficient number of participants with events
|
2.7 months
Interval 1.1 to 4.3
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Time to Response According to RECIST 1.1
|
NA months
Insufficient number of participants with events
|
NA months
Interval 6.9 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
14.1 months
Interval 1.6 to
Insufficient number of participants with events
|
NA months
Interval 1.4 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=40 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=35 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=6 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=11 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=11 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Time to Response According to iRECIST
|
NA months
Insufficient number of participants with events
|
NA months
Interval 6.9 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
14.1 months
Interval 1.6 to
Insufficient number of participants with events
|
NA months
Interval 1.4 to
Insufficient number of participants with events
|
NA months
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Duration of Response According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
|
—
|
—
|
NA months
Interval 4.3 to
Insufficient number of participants with events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Clinical Benefit Rate According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
|
—
|
—
|
45.0 percentage of participants
Interval 29.3 to 61.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 years and 2 monthsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Progression-free Survival According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
|
—
|
—
|
2.6 months
Interval 1.4 to 6.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 yearsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Circulating Tumor Cell Count Conversion as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
|
—
|
—
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 yearsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Percentage of Patients With Confirmed Prostate-specific Antigen Decline of ≥50% as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
|
—
|
—
|
13.5 percentage of participants
Interval 5.8 to 26.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 2 yearsOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=40 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Time to Confirmed Prostate-specific Antigen Progression as Assessed According to Prostate Cancer Clinical Trials Working Group 3 Modified RECIST 1.1
|
—
|
—
|
2.3 months
Interval 1.3 to 4.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, 30 (+/-5) minutes after nanrilkefusp alfa administrationOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=53 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=38 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=37 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 30 (+/-5) Minutes After Nanrilkefusp Alfa Administration
|
0 ng/mL
Interval 0.0 to 4.37
|
0.9020 ng/mL
Interval 0.151 to 3.69
|
1.0900 ng/mL
Interval 0.26 to 3.85
|
0.5890 ng/mL
Interval 0.487 to 4.53
|
0.7200 ng/mL
Interval 0.363 to 5.58
|
0.9470 ng/mL
Interval 0.358 to 3.46
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, 2 hours (+/-15 minutes) after nanrilkefusp alfa administrationOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=53 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=38 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=37 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Nanrilkefusp Alfa Concentration Profile, Cycle 1 Day 1, 2 Hours (+/-15 Minutes) After Nanrilkefusp Alfa Administration
|
3.4500 ng/mL
Interval 0.291 to 15.8
|
3.1300 ng/mL
Interval 0.288 to 10.7
|
3.6800 ng/mL
Interval 0.628 to 15.6
|
3.6700 ng/mL
Interval 1.22 to 11.9
|
3.4250 ng/mL
Interval 1.35 to 19.1
|
2.5600 ng/mL
Interval 0.82 to 4.07
|
SECONDARY outcome
Timeframe: Cycle 4 Day 1, approximately 9 weeksOutcome measures
| Measure |
Metastatic Castration-resistant Prostate Cancer
n=53 Participants
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=39 Participants
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
Non-small Cell Lung Cancer
n=39 Participants
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 Participants
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 Participants
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 Participants
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
|---|---|---|---|---|---|---|
|
Number of Patients With Anti-drug Antibodies, Cycle 4 Day 1
|
4 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
Non-small Cell Lung Cancer
Serious events: 23 serious events
Other events: 40 other events
Deaths: 17 deaths
Colorectal Cancer
Serious events: 3 serious events
Other events: 8 other events
Deaths: 3 deaths
Cutaneous Squamous Cell Carcinoma
Serious events: 3 serious events
Other events: 12 other events
Deaths: 4 deaths
Hepatocellular Carcinoma
Serious events: 3 serious events
Other events: 12 other events
Deaths: 5 deaths
Metastatic Castration-resistant Prostate Cancer
Serious events: 28 serious events
Other events: 54 other events
Deaths: 24 deaths
Ovarian Cancer
Serious events: 28 serious events
Other events: 39 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Non-small Cell Lung Cancer
n=40 participants at risk
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 participants at risk
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 participants at risk
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 participants at risk
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
Metastatic Castration-resistant Prostate Cancer
n=54 participants at risk
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=39 participants at risk
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
12.5%
5/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
13.0%
7/54 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
15.4%
6/39 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Vascular disorders
Jugular vein thrombosis
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Pyrexia
|
5.0%
2/40 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
20.5%
8/39 • Number of events 14 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
General physical health deterioration
|
10.0%
4/40 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Fatigue
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Death
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Discomfort
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Oedema peripheral
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Immune system disorders
Cytokine release syndrome
|
5.0%
2/40 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
13.0%
7/54 • Number of events 9 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
17.9%
7/39 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
2/40 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Blood creatinine increased
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Cardiac disorders
Cardiogenic shock
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Nervous system disorders
Cerebral haemorrhage
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Nervous system disorders
Epilepsy
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
3.7%
2/54 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Haematemesis
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
3.7%
2/54 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
3.7%
2/54 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
3.7%
2/54 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
3.7%
2/54 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
COVID-19
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
Other adverse events
| Measure |
Non-small Cell Lung Cancer
n=40 participants at risk
Advanced and/or metastatic non-small cell lung cancer with disease progression on or after an immune checkpoint inhibitor-containing regimen and a platinum-containing regimen, with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations, and who were not amenable to curative treatment
|
Colorectal Cancer
n=8 participants at risk
Microsatellite instability-high or mismatch repair deficient colorectal cancer that was unresectable or metastatic
|
Cutaneous Squamous Cell Carcinoma
n=12 participants at risk
Recurrent or metastatic cutaneous squamous cell carcinoma that was not curable by surgery or radiation and in second line if refractory or relapsed after a checkpoint inhibitor-containing regimen and radiotherapy was not feasible
|
Hepatocellular Carcinoma
n=12 participants at risk
Advanced hepatocellular carcinoma after recurrence or failure of an immune checkpoint inhibitor (not applicable in France)
|
Metastatic Castration-resistant Prostate Cancer
n=54 participants at risk
Treatment-refractory metastatic castration-resistant prostate cancer after recurrence or failure of docetaxel and prior treatment with abiraterone, enzalutamide, or any other androgen receptor-targeted agent
|
Ovarian Cancer
n=39 participants at risk
Advanced recurrent ovarian cancer after recurrence or failure on the last platinum-based therapy within 6 months
|
|---|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
37.5%
15/40 • Number of events 23 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
37.5%
3/8 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
29.6%
16/54 • Number of events 30 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
23.1%
9/39 • Number of events 10 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Lymphocyte count decreased
|
42.5%
17/40 • Number of events 26 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
62.5%
5/8 • Number of events 10 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
33.3%
4/12 • Number of events 10 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
66.7%
8/12 • Number of events 14 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
38.9%
21/54 • Number of events 42 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
17.9%
7/39 • Number of events 9 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Alanine aminotransferase increased
|
35.0%
14/40 • Number of events 22 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
2/8 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.9%
14/54 • Number of events 17 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
23.1%
9/39 • Number of events 11 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Blood bilirubin increased
|
12.5%
5/40 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
14.8%
8/54 • Number of events 9 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
2/8 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
18.5%
10/54 • Number of events 24 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 10 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Platelet count decreased
|
7.5%
3/40 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
20.4%
11/54 • Number of events 32 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Blood creatinine increased
|
10.0%
4/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
11.1%
6/54 • Number of events 17 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
8/40 • Number of events 11 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
3.7%
2/54 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Amylase increased
|
7.5%
3/40 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 13 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
10.3%
4/39 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Weight decreased
|
12.5%
5/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Investigations
Lipase increased
|
10.0%
4/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Vascular disorders
Hypotension
|
22.5%
9/40 • Number of events 11 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
2/8 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.9%
14/54 • Number of events 43 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.8%
5/39 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Vascular disorders
Hypertension
|
10.0%
4/40 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
10.3%
4/39 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Cardiac disorders
Tachycardia
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
10.3%
4/39 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Nervous system disorders
Headache
|
15.0%
6/40 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
9.3%
5/54 • Number of events 8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.8%
5/39 • Number of events 8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Nervous system disorders
Tremor
|
10.0%
4/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
14.8%
8/54 • Number of events 14 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Pyrexia
|
65.0%
26/40 • Number of events 114 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
50.0%
4/8 • Number of events 40 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
83.3%
10/12 • Number of events 30 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
58.3%
7/12 • Number of events 19 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
70.4%
38/54 • Number of events 161 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
92.3%
36/39 • Number of events 154 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Chills
|
37.5%
15/40 • Number of events 20 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
37.5%
3/8 • Number of events 12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 11 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
38.9%
21/54 • Number of events 32 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
38.5%
15/39 • Number of events 54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Fatigue
|
37.5%
15/40 • Number of events 16 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
50.0%
6/12 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
24.1%
13/54 • Number of events 20 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
35.9%
14/39 • Number of events 18 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Injection site reaction
|
27.5%
11/40 • Number of events 48 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
37.5%
3/8 • Number of events 9 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
33.3%
4/12 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
24.1%
13/54 • Number of events 25 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
48.7%
19/39 • Number of events 92 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Asthenia
|
30.0%
12/40 • Number of events 12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
33.3%
4/12 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
37.0%
20/54 • Number of events 25 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
33.3%
13/39 • Number of events 17 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Oedema peripheral
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
10.3%
4/39 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
General disorders
Chest pain
|
12.5%
5/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Blood and lymphatic system disorders
Anaemia
|
42.5%
17/40 • Number of events 23 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
57.4%
31/54 • Number of events 52 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
20.5%
8/39 • Number of events 9 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Immune system disorders
Cytokine release syndrome
|
15.0%
6/40 • Number of events 23 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
2/8 • Number of events 10 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
22.2%
12/54 • Number of events 38 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
11/40 • Number of events 14 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
33.3%
4/12 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
31.5%
17/54 • Number of events 33 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
56.4%
22/39 • Number of events 43 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
10/40 • Number of events 18 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 19 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
24.1%
13/54 • Number of events 20 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
61.5%
24/39 • Number of events 36 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
5/40 • Number of events 8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
30.8%
12/39 • Number of events 15 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
17.9%
7/39 • Number of events 8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/54 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.6%
10/39 • Number of events 10 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.5%
7/40 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.0%
3/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
1.9%
1/54 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
15.4%
6/39 • Number of events 8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
6/40 • Number of events 8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
3.7%
2/54 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Endocrine disorders
Hypothyroidism
|
7.5%
3/40 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
11.1%
6/54 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
5/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
3/40 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
12.5%
1/8 • Number of events 6 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.5%
11/40 • Number of events 12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
20.4%
11/54 • Number of events 13 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
25.6%
10/39 • Number of events 11 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.5%
5/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
16.7%
2/12 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
11.1%
6/54 • Number of events 9 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.5%
1/40 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
22.2%
12/54 • Number of events 19 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
2.6%
1/39 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.5%
7/40 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
8.3%
1/12 • Number of events 1 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.1%
2/39 • Number of events 2 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.0%
6/40 • Number of events 11 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.4%
4/54 • Number of events 7 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/39 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.5%
3/40 • Number of events 5 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/8 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
0.00%
0/12 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
5.6%
3/54 • Number of events 3 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
7.7%
3/39 • Number of events 4 • Day 1 up to approximately 2 years and 2 months
Only treatment-emergent AEs (TEAEs) were analyzed (see the definition above); the tables include information on TEAEs, serious TEAEs, and all deaths; causality was assessed by investigators. All-cause mortality was assessed in Enrolled patients (all who signed the ICF) whereas AEs were assessed in All-subjects-as-treated (all who were treated with nanrilkefusp alfa or pembrolizumab).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this clinical trial will be published and/or presented at scientific meetings in their totality in a timely manner. Any formal publication of clinical trial results will be a collaborative effort between the sponsor and the investigator(s). All manuscripts or abstracts will be reviewed and approved in written by the sponsor before submission. The sponsor may request a delay in publication if there are important intellectual property concerns.
- Publication restrictions are in place
Restriction type: OTHER