Trial Outcomes & Findings for Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) (NCT NCT02391116)
NCT ID: NCT02391116
Last Updated: 2019-01-04
Results Overview
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
Results posted on
2019-01-04
Participant Flow
The study was conducted at 32 centers across 10 countries, between 08 May 2015 (first patient first visit) and 18 January 2018 (last patient last visit).
A total of 91 participants were screened, of which 67 were assigned to study treatment and also started the treatment, and 24 were screened but never assigned to treatment. Altogether 27 participants were excluded from the per protocol set, which comprised 40 participants.
Participant milestones
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
|---|---|
|
Treatment
STARTED
|
67
|
|
Treatment
Included in Per Protocol Set
|
40
|
|
Treatment
COMPLETED
|
53
|
|
Treatment
NOT COMPLETED
|
14
|
|
Safety Follow-up
STARTED
|
56
|
|
Safety Follow-up
COMPLETED
|
43
|
|
Safety Follow-up
NOT COMPLETED
|
13
|
|
Active Follow-up
STARTED
|
9
|
|
Active Follow-up
COMPLETED
|
6
|
|
Active Follow-up
NOT COMPLETED
|
3
|
|
Survival Follow-up
STARTED
|
46
|
|
Survival Follow-up
COMPLETED
|
42
|
|
Survival Follow-up
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
|---|---|
|
Treatment
Withdrawal by Subject
|
1
|
|
Treatment
Protocol Violation
|
1
|
|
Treatment
Adverse Event (AE) Without Clinical PD
|
9
|
|
Treatment
AE with Clinical PD
|
3
|
|
Safety Follow-up
Adverse Event
|
1
|
|
Safety Follow-up
Withdrawal by Subject
|
4
|
|
Safety Follow-up
Switching to Other Therapy
|
4
|
|
Safety Follow-up
No Follow Up
|
1
|
|
Safety Follow-up
Deterioration of General Conditions
|
3
|
|
Active Follow-up
Withdrawal by Subject
|
1
|
|
Active Follow-up
Switching to Other Therapy
|
2
|
|
Survival Follow-up
Withdrawal by Subject
|
3
|
|
Survival Follow-up
Switching to Other Therapy
|
1
|
Baseline Characteristics
Full analysis set (FAS) and per protocol set (PPS)
Baseline characteristics by cohort
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
|---|---|
|
Age, Continuous
Full analysis set (FAS)
|
65.3 Years
STANDARD_DEVIATION 14.5 • n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
Age, Continuous
Per protocol set (PPS)
|
69.2 Years
STANDARD_DEVIATION 12.2 • n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
Sex: Female, Male
Full analysis set (FAS) · Female
|
28 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
Sex: Female, Male
Full analysis set (FAS) · Male
|
39 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
Sex: Female, Male
Per protocol set (PPS) · Female
|
15 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
Sex: Female, Male
Per protocol set (PPS) · Male
|
25 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
CD79b Status
Full analysis set (FAS) · CD79b Mutant
|
9 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
CD79b Status
Full analysis set (FAS) · CD79b Wild-type
|
45 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
CD79b Status
Full analysis set (FAS) · CD79b Status Missing
|
13 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
CD79b Status
Per protocol set (PPS) · CD79b Mutant
|
8 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
CD79b Status
Per protocol set (PPS) · CD79b Wild-type
|
32 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
CD79b Status
Per protocol set (PPS) · CD79b Status Missing
|
0 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Full analysis set (FAS) · Activated B-cell-like (ABC)
|
19 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Full analysis set (FAS) · Germinal center B-cell-like (GCB)
|
30 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Full analysis set (FAS) · Unclassifiable
|
3 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Full analysis set (FAS) · DLBCL/COO Subtype Missing
|
15 Participants
n=67 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Per protocol set (PPS) · Activated B-cell-like (ABC)
|
16 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Per protocol set (PPS) · Germinal center B-cell-like (GCB)
|
22 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Per protocol set (PPS) · Unclassifiable
|
2 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
|
DLBCL / Cell of Origin (COO) Subtype
Per protocol set (PPS) · DLBCL/COO Subtype Missing
|
0 Participants
n=40 Participants • Full analysis set (FAS) and per protocol set (PPS)
|
PRIMARY outcome
Timeframe: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)Population: Full analysis set (FAS) and per protocol set (PPS)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
Full analysis set (FAS)
|
19.4 Percentage of participants
Interval 11.9 to 29.1
|
—
|
—
|
—
|
|
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
Per protocol set (PPS)
|
25.0 Percentage of participants
Interval 14.2 to 38.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)Population: Full analysis set (FAS) and per protocol set (PPS)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=9 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=45 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=13 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
ORR by CD79b Status Based on Investigator Assessment
Full analysis set (FAS)
|
22.2 Percentage of participants
Interval 4.1 to 55.0
|
20.0 Percentage of participants
Interval 10.9 to 32.3
|
15.4 Percentage of participants
Interval 2.8 to 41.0
|
—
|
|
ORR by CD79b Status Based on Investigator Assessment
Per protocol set (PPS)
|
25.0 Percentage of participants
Interval 4.6 to 60.0
|
25.0 Percentage of participants
Interval 13.1 to 40.6
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)Population: Full analysis set (FAS) and per protocol set (PPS)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=19 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=30 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=3 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
n=15 Participants
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
ORR by DLBCL/COO Subtype Based on Investigator Assessment
Full analysis set (FAS)
|
31.6 Percentage of participants
Interval 14.7 to 53.0
|
13.3 Percentage of participants
Interval 4.7 to 28.0
|
33.3 Percentage of participants
Interval 1.7 to 86.5
|
13.3 Percentage of participants
Interval 2.4 to 36.3
|
|
ORR by DLBCL/COO Subtype Based on Investigator Assessment
Per protocol set (PPS)
|
37.5 Percentage of participants
Interval 17.8 to 60.9
|
13.6 Percentage of participants
Interval 3.8 to 31.6
|
50.0 Percentage of participants
Interval 2.5 to 97.5
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=13 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Duration of Response (DOR) in Total Population
|
132 Days
Interval 57.0 to 345.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=2 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=9 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=2 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
DOR by CD79b Status
|
516 Days
Interval 417.0 to 615.0
|
113 Days
Interval 39.0 to 272.0
|
113 Days
Interval 93.0 to 132.0
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment
The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=6 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=4 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=1 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
n=2 Participants
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
DOR by DLBCL/COO Subtype
|
193 Days
Interval 39.0 to 417.0
|
183 Days
Interval 63.0 to 615.0
|
52 Days
Value cannot be estimated due to censored data.
|
113 Days
Interval 93.0 to 132.0
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) in Total Population
|
54 Days
Interval 50.0 to 84.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=9 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=45 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=13 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
PFS by CD79b Status
|
73 Days
Interval 43.0 to 465.0
|
52 Days
Interval 46.0 to 88.0
|
56 Days
Interval 46.0 to 138.0
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=19 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=30 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=3 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
n=15 Participants
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
PFS by DLBCL/COO Subtype
|
73 Days
Interval 44.0 to 101.0
|
52 Days
Interval 46.0 to 116.0
|
84 Days
Interval 26.0 to 164.0
|
51 Days
Interval 33.0 to 58.0
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Overall Survival (OS) in Total Population
|
224 Days
Interval 104.0 to 327.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=9 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=45 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=13 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
OS by CD79b Status
|
178 Days
Interval 57.0 to
Value cannot be estimated due to censored data.
|
242 Days
Interval 73.0 to 385.0
|
224 Days
Interval 56.0 to 388.0
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=19 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=30 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=3 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
n=15 Participants
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
OS by DLBCL/COO Subtype
|
210 Days
Interval 63.0 to 421.0
|
287 Days
Interval 94.0 to 436.0
|
164 Days
Interval 93.0 to 273.0
|
160 Days
Interval 46.0 to 400.0
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Participants who failed to achieve CR or PR but achieved SD in full analysis set based on the investigator assessment
The duration of stable disease (DOSD) was defined as the time (in days) from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier. The DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD (stable disease), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=14 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Duration of Stable Disease (DOSD) in Total Population
|
106 Days
Interval 73.0 to 138.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Disease Control Rate (DCR) in Total Population
|
40.3 Percentage of participants
Interval 30.2 to 51.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=9 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=45 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=13 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
DCR by CD79b Status
|
55.6 Percentage of participants
Interval 25.1 to 83.1
|
40.0 Percentage of participants
Interval 27.7 to 53.3
|
30.8 Percentage of participants
Interval 11.3 to 57.3
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Full analysis set (FAS)
The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=19 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=30 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=3 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
n=15 Participants
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
DCR by DLBCL/COO Subtype
|
52.6 Percentage of participants
Interval 32.0 to 72.6
|
40.0 Percentage of participants
Interval 25.0 to 56.6
|
33.3 Percentage of participants
Interval 1.7 to 86.5
|
26.7 Percentage of participants
Interval 9.7 to 51.1
|
SECONDARY outcome
Timeframe: From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participantPopulation: Safety analysis set (SAF)
A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TEAE
|
65 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TESAE
|
44 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs firstPopulation: Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment
The time to response (TTR) was defined as the time (days) from start of study treatment to the date of first observed response (first measured CR or PR). TTR was defined for responders only (i.e. participants with CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=13 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
Time to Response (TTR) in Total Population
|
52 Days
Interval 49.0 to 56.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)Population: Full analysis set
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
ORR in Total Population Based on Central Imaging Review
|
22.4 Percentage of participants
Interval 14.3 to 32.4
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)Population: Full analysis set (FAS)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=9 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=45 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=13 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
ORR by CD79b Status Based on Central Imaging Review
|
44.4 Percentage of participants
Interval 16.9 to 74.9
|
20.0 Percentage of participants
Interval 10.9 to 32.3
|
15.4 Percentage of participants
Interval 2.8 to 41.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)Population: Full analysis set (FAS)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.
Outcome measures
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=19 Participants
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
CD79b Wild-type
n=30 Participants
Included all participants with CD79b wild-type classified at baseline depending on biomarker value
|
CD79b Status Missing
n=3 Participants
Included all participants with CD79b status missing at baseline
|
DLBCL/COO Subtype Missing
n=15 Participants
Included all participants with DLBCL/COO subtype missing at baseline
|
|---|---|---|---|---|
|
ORR by DLBCL/COO Subtype Based on Central Imaging Review
|
47.4 Percentage of participants
Interval 27.4 to 68.0
|
13.3 Percentage of participants
Interval 4.7 to 28.0
|
0.0 Percentage of participants
Interval 0.0 to 63.2
|
13.3 Percentage of participants
Interval 2.4 to 36.3
|
Adverse Events
Copanlisib (Aliqopa, BAY80-6946)
Serious events: 44 serious events
Other events: 64 other events
Deaths: 53 deaths
Serious adverse events
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 participants at risk
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Eye disorders
Diplopia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Gastrointestinal disorders
Colitis
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
General disorders
Asthenia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
General disorders
Death
|
3.0%
2/67 • Number of events 2 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
General disorders
Fatigue
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
General disorders
Pyrexia
|
6.0%
4/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
General disorders
Sudden death
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
General disorders
General physical health deterioration
|
13.4%
9/67 • Number of events 9 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Cystitis
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Lower respiratory tract infection
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Thrombophlebitis septic
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Urosepsis
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Lung infection
|
3.0%
2/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Respiratory tract infection viral
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Splenic infection fungal
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Hepatic infection fungal
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Investigations
Amylase increased
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Investigations
Blood creatinine increased
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Investigations
Lipase increased
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Investigations
Neutrophil count decreased
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Metabolism and nutrition disorders
Cachexia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.5%
5/67 • Number of events 5 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
2/67 • Number of events 2 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory carcinoma of the breast
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Nervous system disorders
Neurological symptom
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
2/67 • Number of events 2 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
2/67 • Number of events 2 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Vascular disorders
Hypertension
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/67 • Number of events 1 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
|
Other adverse events
| Measure |
Copanlisib (Aliqopa, BAY80-6946)
n=67 participants at risk
Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
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Blood and lymphatic system disorders
Anaemia
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9.0%
6/67 • Number of events 6 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Blood and lymphatic system disorders
Neutropenia
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13.4%
9/67 • Number of events 9 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Blood and lymphatic system disorders
Thrombocytopenia
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9.0%
6/67 • Number of events 6 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Cardiac disorders
Tachycardia
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Abdominal pain
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7.5%
5/67 • Number of events 5 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Constipation
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16.4%
11/67 • Number of events 11 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Diarrhoea
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37.3%
25/67 • Number of events 38 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Mouth ulceration
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11.9%
8/67 • Number of events 8 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Nausea
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29.9%
20/67 • Number of events 23 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Stomatitis
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7.5%
5/67 • Number of events 5 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Vomiting
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17.9%
12/67 • Number of events 13 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Gastrointestinal disorders
Paraesthesia oral
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4.5%
3/67 • Number of events 5 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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General disorders
Asthenia
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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General disorders
Chest pain
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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General disorders
Chills
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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General disorders
Fatigue
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26.9%
18/67 • Number of events 19 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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General disorders
Mucosal inflammation
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6.0%
4/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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General disorders
Oedema peripheral
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10.4%
7/67 • Number of events 7 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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General disorders
Pyrexia
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17.9%
12/67 • Number of events 12 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Infections and infestations
Upper respiratory tract infection
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6.0%
4/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Injury, poisoning and procedural complications
Fall
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4.5%
3/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Investigations
Lipase increased
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Investigations
Lymphocyte count decreased
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4.5%
3/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Investigations
Platelet count decreased
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7.5%
5/67 • Number of events 5 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Investigations
Weight decreased
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Investigations
White blood cell count decreased
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Metabolism and nutrition disorders
Hyperglycaemia
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31.3%
21/67 • Number of events 27 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Metabolism and nutrition disorders
Hypoglycaemia
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Metabolism and nutrition disorders
Hypokalaemia
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11.9%
8/67 • Number of events 15 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Metabolism and nutrition disorders
Hyponatraemia
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6.0%
4/67 • Number of events 6 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Metabolism and nutrition disorders
Hypophosphataemia
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4.5%
3/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Metabolism and nutrition disorders
Decreased appetite
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14.9%
10/67 • Number of events 14 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Musculoskeletal and connective tissue disorders
Arthralgia
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6.0%
4/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Musculoskeletal and connective tissue disorders
Muscle spasms
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9.0%
6/67 • Number of events 7 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Musculoskeletal and connective tissue disorders
Pain in extremity
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4.5%
3/67 • Number of events 5 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
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6.0%
4/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Nervous system disorders
Dizziness
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6.0%
4/67 • Number of events 6 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Nervous system disorders
Headache
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13.4%
9/67 • Number of events 9 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Nervous system disorders
Paraesthesia
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6.0%
4/67 • Number of events 6 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Psychiatric disorders
Insomnia
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Respiratory, thoracic and mediastinal disorders
Cough
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17.9%
12/67 • Number of events 12 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
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7.5%
5/67 • Number of events 5 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Respiratory, thoracic and mediastinal disorders
Productive cough
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6.0%
4/67 • Number of events 4 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Skin and subcutaneous tissue disorders
Dry skin
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9.0%
6/67 • Number of events 7 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Skin and subcutaneous tissue disorders
Rash
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13.4%
9/67 • Number of events 10 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Vascular disorders
Haematoma
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Vascular disorders
Hypertension
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40.3%
27/67 • Number of events 42 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Vascular disorders
Hypotension
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4.5%
3/67 • Number of events 3 • From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60