Trial Outcomes & Findings for A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension (NCT NCT06212752)

Last Updated: 2025-11-12

Results Overview

ORR was defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). The percentage of participants with CR or PR were reported.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

39 participants

Primary outcome timeframe

Up to ~ 16 months

Results posted on

2025-11-12

Participant Flow

39 Japanese participants were randomized and received treatment (global study \[NCT05722015; n=23\] or to the extension portion \[n=16\]).

Participant milestones

Participant milestones
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Overall Study STARTED	28	11
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	28	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Overall Study Death	5	3
Overall Study Participants ongoing	23	8

Baseline Characteristics

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=28 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=11 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Total n=39 Participants Total of all reporting groups
Age, Continuous	68.3 Years STANDARD_DEVIATION 9.0 • n=10 Participants	70.7 Years STANDARD_DEVIATION 8.2 • n=10 Participants	69.0 Years STANDARD_DEVIATION 8.8 • n=20 Participants
Sex: Female, Male Female	4 Participants n=10 Participants	3 Participants n=10 Participants	7 Participants n=20 Participants
Sex: Female, Male Male	24 Participants n=10 Participants	8 Participants n=10 Participants	32 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=10 Participants	11 Participants n=10 Participants	39 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Asian	28 Participants n=10 Participants	11 Participants n=10 Participants	39 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) White	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 0	18 Participants n=10 Participants	6 Participants n=10 Participants	24 Participants n=20 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG = 1	10 Participants n=10 Participants	5 Participants n=10 Participants	15 Participants n=20 Participants
Histology (squamous vs. nonsquamous) Non-squamous	14 Participants n=10 Participants	9 Participants n=10 Participants	23 Participants n=20 Participants
Histology (squamous vs. nonsquamous) Squamous	14 Participants n=10 Participants	2 Participants n=10 Participants	16 Participants n=20 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status TPS <1%	12 Participants n=10 Participants	6 Participants n=10 Participants	18 Participants n=20 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status TPS 1-49%	11 Participants n=10 Participants	4 Participants n=10 Participants	15 Participants n=20 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status TPS ≥50%	2 Participants n=10 Participants	1 Participants n=10 Participants	3 Participants n=20 Participants
Programmed Cell Death Ligand 1 (PD-L1) Status Unknown	3 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants

PRIMARY outcome

Timeframe: Up to ~ 16 months

Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion.

Outcome measures

Outcome measures
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=28 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=11 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Objective Response Rate (ORR)	64.3 Percentage of participants Interval 44.1 to 81.4	18.2 Percentage of participants Interval 2.3 to 51.8

SECONDARY outcome

Timeframe: Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days4, 15, 29, and 42 postdose (cycle length = 42 days)

Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 with at least 1 valid postdose pharmacokinetic (PK) sample available in Cycle1 and for whom a model-based assessment of AUC0-6 weeks could be made.

AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.

Outcome measures

Outcome measures
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=28 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=11 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose	1864.76 µg·day/mL Geometric Coefficient of Variation 22.18	1697.98 µg·day/mL Geometric Coefficient of Variation 18.50

SECONDARY outcome

Timeframe: Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)

Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1through Cycle 3 and for whom a model-based assessment of Ctrough could be made.

Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.

Outcome measures

Outcome measures
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=24 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=7 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State	45.11 µg/ml Geometric Coefficient of Variation 35.58	30.86 µg/ml Geometric Coefficient of Variation 24.93

SECONDARY outcome

Timeframe: Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)

Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received who received a dose in Cycle 1 with at least 1 valid postdose PK sample available in Cycle 1 and for whom a model-based assessment of Cmax could be made.

Cmax was defined as the maximum serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, geometric mean Cmax value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.

Outcome measures

Outcome measures
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=28 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=11 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose	71.54 µg/ml Geometric Coefficient of Variation 23.7	141.9 µg/ml Geometric Coefficient of Variation 16.4

SECONDARY outcome

Timeframe: At designated time points (Up to ~28 months)

Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 with at least 1 valid postdose PK sample available in Cycle 1 and for whom a model-based assessment of Ctrough could be made.

Ctrough was defined as the lowest serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.

Outcome measures

Outcome measures
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=28 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=11 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose	23.62 µg/ml Geometric Coefficient of Variation 27.9	16.27 µg/ml Geometric Coefficient of Variation 29.7

SECONDARY outcome

Timeframe: At designated time points (Up to ~28 months)

Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of AUC0-6 weeks could be made.

AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented.

Outcome measures

Outcome measures
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=24 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=7 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State	3116 µg•day/ml Geometric Coefficient of Variation 27.3	2514 µg•day/ml Geometric Coefficient of Variation 17.3

SECONDARY outcome

Timeframe: Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)

Population: All Japanese participants who were randomized to the global study (NCT05722015) or to the extension portion who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of Cmax could be made.

Cmax was defined as the maximum serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints to determine Cmax. Per protocol, geometric mean Cmax value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented.

Outcome measures

Outcome measures
Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=24 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=7 Participants Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State	108.1 µg/mL Geometric Coefficient of Variation 25.3	159.8 µg/mL Geometric Coefficient of Variation 13.2

SECONDARY outcome

Timeframe: Up to~25 months

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy

Serious events: 12 serious events

Other events: 28 other events

Deaths: 5 deaths

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Serious events: 3 serious events

Other events: 11 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

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 The results of this study may be published or presented at scientific meetings. The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy n=28 participants at risk Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy n=11 participants at risk Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.
Blood and lymphatic system disorders Febrile neutropenia	7.1% 2/28 • Number of events 2 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Cardiac disorders Cardiac failure congestive	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Eye disorders Cataract	0.00% 0/28 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	9.1% 1/11 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Gastrointestinal disorders Colitis	0.00% 0/28 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	9.1% 1/11 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Gastrointestinal disorders Enterocolitis	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
General disorders Pyrexia	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	9.1% 1/11 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Infections and infestations Encephalitis	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Infections and infestations Pneumonia	7.1% 2/28 • Number of events 2 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	9.1% 1/11 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Infections and infestations Pneumonia bacterial	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/28 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	9.1% 1/11 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Renal and urinary disorders Renal impairment	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 2/28 • Number of events 2 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.
Skin and subcutaneous tissue disorders Rash macular	3.6% 1/28 • Number of events 1 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.	0.00% 0/11 • Up to approximately 16 months All-Cause Mortality includes all randomized Japanese participants. Serious \& Other adverse events (AEs) include all randomized Japanese participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data were reported by treatment received.