Trial Outcomes & Findings for A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008) (NCT NCT05508867)
NCT ID: NCT05508867
Last Updated: 2026-09-01
Results Overview
PFS was defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurred first. Progressive disease was defined as uptake moderately or markedly higher than the liver with an increase in overall uptake compared with nadir, and/or the appearance of new lesions consistent with lymphoma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
Up to approximately 34 months
Results posted on
2026-09-01
Participant Flow
Participants with programmed cell death 1 (PD-1) protein- or programmed cell death ligand 1 (PD-L1) \[PD-(L)1\]-refractory, relapsed or refractory classical Hodgkin lymphoma were recruited to receive the coformulation favezelimab/pembrolizumab (MK-4280A) or physician's choice chemotherapy (gemcitabine or bendamustine).
Participants were randomized 1:1 to receive favezelimab/pembrolizumab or physician's choice chemotherapy (gemcitabine or bendamustine). Participants assigned to gemcitabine or bendamustine could cross over to favezelimab/pembrolizumab if crossover phase criteria were met. Per protocol, response/progression or adverse events (AEs) that occurred after the switchover to favezelimab/pembrolizumab were not counted towards efficacy outcome measures or safety outcome measures, respectively.
Participant milestones
| Measure |
Favezelimab/Pembrolizumab
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
99
|
|
Overall Study
Treated
|
104
|
97
|
|
Overall Study
Switched Over to Favezelimab/Pembrolizumab
|
0
|
52
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
104
|
99
|
Reasons for withdrawal
| Measure |
Favezelimab/Pembrolizumab
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Overall Study
Death
|
15
|
21
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Sponsor Decision
|
86
|
75
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)
Baseline characteristics by cohort
| Measure |
Favezelimab/Pembrolizumab
n=104 Participants
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
n=99 Participants
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 Years
STANDARD_DEVIATION 18.4 • n=14 Participants
|
44.7 Years
STANDARD_DEVIATION 17.8 • n=36 Participants
|
45.4 Years
STANDARD_DEVIATION 18.1 • n=324 Participants
|
|
Sex/Gender, Customized
Female
|
45 Participants
n=14 Participants
|
39 Participants
n=36 Participants
|
84 Participants
n=324 Participants
|
|
Sex/Gender, Customized
Male
|
58 Participants
n=14 Participants
|
60 Participants
n=36 Participants
|
118 Participants
n=324 Participants
|
|
Sex/Gender, Customized
Undifferentiated
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=14 Participants
|
24 Participants
n=36 Participants
|
42 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=14 Participants
|
74 Participants
n=36 Participants
|
156 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=14 Participants
|
14 Participants
n=36 Participants
|
28 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=14 Participants
|
6 Participants
n=36 Participants
|
10 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=14 Participants
|
77 Participants
n=36 Participants
|
159 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Prior Autologous Stem Cell Transplant Status (auto-SCT)
Yes
|
55 Participants
n=14 Participants
|
52 Participants
n=36 Participants
|
107 Participants
n=324 Participants
|
|
Prior Autologous Stem Cell Transplant Status (auto-SCT)
No
|
49 Participants
n=14 Participants
|
47 Participants
n=36 Participants
|
96 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 34 monthsPopulation: All randomized participants analyzed in the treatment arm to which they were randomized.
PFS was defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurred first. Progressive disease was defined as uptake moderately or markedly higher than the liver with an increase in overall uptake compared with nadir, and/or the appearance of new lesions consistent with lymphoma.
Outcome measures
| Measure |
Favezelimab/Pembrolizumab
n=104 Participants
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
n=99 Participants
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Lugano Response Criteria as Assessed by Investigator
|
6.4 Months
Interval 5.7 to 8.5
|
5.7 Months
Interval 5.6 to 6.4
|
SECONDARY outcome
Timeframe: Up to approximately 34 monthsPopulation: All randomized participants analyzed in the treatment arm to which they were randomized.
OS was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Favezelimab/Pembrolizumab
n=104 Participants
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
n=99 Participants
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
NA = Median OS, lower limit for OS, and upper limit for OS was not reached due to a low number of deaths at the time of the data cutoff date
|
NA Months
Interval 29.4 to
NA = Median OS and upper limit for OS was not reached due to a low number of deaths at the time of the data cutoff date
|
SECONDARY outcome
Timeframe: Up to approximately 34 monthsPopulation: All randomized participants analyzed in the treatment arm to which they were randomized.
ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator. CR or PR were evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal).
Outcome measures
| Measure |
Favezelimab/Pembrolizumab
n=104 Participants
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
n=99 Participants
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Lugano Response Criteria as Assessed by Investigator
|
44.2 Percentage of Participants
Interval 34.5 to 54.3
|
67.7 Percentage of Participants
Interval 57.5 to 76.7
|
SECONDARY outcome
Timeframe: Up to approximately 34 monthsPopulation: All randomized participants who achieved CR or PR, analyzed in the treatment arm to which they were randomized.
For participants who demonstrated CR or PR per Lugano criteria 2014 as assessed by investigator, DOR was defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. CR or PR were evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal).
Outcome measures
| Measure |
Favezelimab/Pembrolizumab
n=46 Participants
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
n=67 Participants
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Duration of Response (DOR) Per Lugano Response Criteria as Assessed by Investigator
|
11.0 Months
Interval 5.6 to 14.9
|
5.4 Months
Interval 3.0 to 5.7
|
SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: All randomized participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is presented.
Outcome measures
| Measure |
Favezelimab/Pembrolizumab
n=104 Participants
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
n=97 Participants
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
|
101 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 28 monthsPopulation: All randomized participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
Favezelimab/Pembrolizumab
n=104 Participants
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Physician's Choice of Chemotherapy (Bendamustine or Gemcitabine)
n=97 Participants
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
|
15 Participants
|
4 Participants
|
Adverse Events
Favezelimab/Pembrolizumab
Serious events: 25 serious events
Other events: 93 other events
Deaths: 15 deaths
Bendamustine or Gemcitabine
Serious events: 27 serious events
Other events: 85 other events
Deaths: 14 deaths
Bendamustine or Gemcitabine Crossed Over to Favezelimab/Pembrolizumab
Serious events: 9 serious events
Other events: 41 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Favezelimab/Pembrolizumab
n=104 participants at risk
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Bendamustine or Gemcitabine
n=97 participants at risk
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
Bendamustine or Gemcitabine Crossed Over to Favezelimab/Pembrolizumab
n=52 participants at risk
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by IV infusion on Day 1 and then Q3W, for up to 35 infusions.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Eye disorders
Uveitis
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Pain
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.2%
5/97 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Abdominal infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
2.1%
2/97 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Gastrointestinal infection
|
0.96%
1/104 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Herpes zoster
|
1.9%
2/104 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Meningitis aseptic
|
1.9%
2/104 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
3.8%
4/104 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
4.1%
4/97 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.1%
3/97 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Tuberculosis
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Urosepsis
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Vascular device infection
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
2/104 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.96%
1/104 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/97 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
Other adverse events
| Measure |
Favezelimab/Pembrolizumab
n=104 participants at risk
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions, or until disease progression was documented per Lugano Response Criteria.
|
Bendamustine or Gemcitabine
n=97 participants at risk
Per protocol, participants received physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles, or until disease progression was documented per Lugano Response Criteria.
|
Bendamustine or Gemcitabine Crossed Over to Favezelimab/Pembrolizumab
n=52 participants at risk
Participants received coformulated favezelimab/pembrolizumab (800 mg/200 mg) by IV infusion on Day 1 and then Q3W, for up to 35 infusions.
|
|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
15.4%
16/104 • Number of events 16 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
13.5%
7/52 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.6%
11/104 • Number of events 22 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
32.0%
31/97 • Number of events 44 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
9.6%
5/52 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
2/104 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.2%
7/97 • Number of events 10 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/104 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
11.3%
11/97 • Number of events 16 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
2/52 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
8/104 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.2%
5/97 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
5/104 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
13.4%
13/97 • Number of events 15 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
4/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.3%
17/104 • Number of events 17 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
8.2%
8/97 • Number of events 8 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
17.3%
9/52 • Number of events 12 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
13/104 • Number of events 15 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
42.3%
41/97 • Number of events 49 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
6/52 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
6/104 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
14.4%
14/97 • Number of events 14 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Asthenia
|
5.8%
6/104 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
6.2%
6/97 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
9.6%
5/52 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Fatigue
|
9.6%
10/104 • Number of events 12 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
22.7%
22/97 • Number of events 28 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
4/52 • Number of events 6 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Oedema peripheral
|
5.8%
6/104 • Number of events 6 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
2.1%
2/97 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
General disorders
Pyrexia
|
14.4%
15/104 • Number of events 18 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
13.4%
13/97 • Number of events 16 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
13.5%
7/52 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
5.8%
6/104 • Number of events 8 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
2/52 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
COVID-19
|
9.6%
10/104 • Number of events 10 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
8/104 • Number of events 8 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
4.1%
4/97 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Sinusitis
|
4.8%
5/104 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
2.1%
2/97 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.4%
15/104 • Number of events 25 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.2%
7/97 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
6/52 • Number of events 6 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
9.6%
10/104 • Number of events 11 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.1%
3/97 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
2/52 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.8%
6/104 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
4.1%
4/97 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
9.6%
5/52 • Number of events 6 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
11.5%
12/104 • Number of events 13 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
13.4%
13/97 • Number of events 19 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
11.5%
6/52 • Number of events 6 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
10.6%
11/104 • Number of events 13 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
12.4%
12/97 • Number of events 18 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
9.6%
5/52 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.9%
3/104 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.1%
3/97 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Lipase increased
|
3.8%
4/104 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
3.8%
4/104 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
11.3%
11/97 • Number of events 16 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
2/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
2.9%
3/104 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
19.6%
19/97 • Number of events 44 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
4/52 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Platelet count decreased
|
3.8%
4/104 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
19.6%
19/97 • Number of events 29 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
2/52 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
Weight decreased
|
4.8%
5/104 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.1%
3/97 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
1.9%
2/104 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
8.2%
8/97 • Number of events 16 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
4/52 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.9%
3/104 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.2%
7/97 • Number of events 7 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
0.00%
0/52 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
5/104 • Number of events 6 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.1%
3/97 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
7/104 • Number of events 10 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.1%
3/97 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.9%
1/52 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
13/104 • Number of events 13 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
2.1%
2/97 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
4/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
7/104 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.2%
5/97 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
4/52 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
9/104 • Number of events 12 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
1.0%
1/97 • Number of events 1 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
4/104 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
8.2%
8/97 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
2.9%
3/104 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.2%
5/97 • Number of events 5 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
2/52 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Nervous system disorders
Headache
|
9.6%
10/104 • Number of events 10 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.2%
7/97 • Number of events 8 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 3 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.5%
14/104 • Number of events 16 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
6.2%
6/97 • Number of events 6 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
3.8%
2/52 • Number of events 2 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.6%
11/104 • Number of events 15 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
13.4%
13/97 • Number of events 13 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
7.7%
4/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
8/104 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
8.2%
8/97 • Number of events 9 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
5.8%
3/52 • Number of events 4 • Up to approximately 38 months
The population for all-cause mortality includes all randomized participants. The population for serious and nonserious AEs includes all treated participants. Participants who received physician's choice of chemotherapy (gemcitabine or bendamustine) could cross over to favezelimab/pembrolizumab if crossover criteria were met. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER