Trial Outcomes & Findings for Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009) (NCT NCT04191135)

NCT ID: NCT04191135

Last Updated: 2025-12-08

Results Overview

PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS is reported based on the product-limit (Kaplan-Meier) method for censored data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

462 participants

Primary outcome timeframe

Up to approximately 29 months

Results posted on

2025-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment Participants receive both carboplatin Area Under The Curve (AUC) 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. Participants may then randomize to one of the blinded treatment arms.	Pembrolizumab + Olaparib This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Induction Treatment STARTED	462	0	0
Induction Treatment Treated	460	0	0
Induction Treatment COMPLETED	0	0	0
Induction Treatment NOT COMPLETED	462	0	0
Randomized Treatment STARTED	0	135	136
Randomized Treatment Treated	0	135	133
Randomized Treatment COMPLETED	0	0	0
Randomized Treatment NOT COMPLETED	0	135	136

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment Participants receive both carboplatin Area Under The Curve (AUC) 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. Participants may then randomize to one of the blinded treatment arms.	Pembrolizumab + Olaparib This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Induction Treatment Not Treated	2	0	0
Induction Treatment Ongoing to Blinded Treatment Period	271	0	0
Induction Treatment Adverse Event	25	0	0
Induction Treatment Clinical Progression	8	0	0
Induction Treatment Excluded Medication	1	0	0
Induction Treatment Failure to Meet Continuation Criteria	2	0	0
Induction Treatment Failure to Meet Randomization Criteria	2	0	0
Induction Treatment Physician Decision	2	0	0
Induction Treatment Progressive Disease	135	0	0
Induction Treatment Protocol Violation	10	0	0
Induction Treatment Withdrawal by Subject	4	0	0
Randomized Treatment Death	0	50	54
Randomized Treatment Lost to Follow-up	0	0	1
Randomized Treatment Withdrawal by Subject	0	2	0
Randomized Treatment Ongoing in Trial	0	83	81

Baseline Characteristics

Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment n=189 Participants Participants receive both carboplatin Area Under The Curve (AUC) 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle during the induction period for 4-6 cycles. These participants did not randomize to a post-induction arm.	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=136 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.	Total n=460 Participants Total of all reporting groups
Age, Continuous	53.8 Years STANDARD_DEVIATION 12.7 • n=37 Participants	53.9 Years STANDARD_DEVIATION 12.0 • n=37 Participants	52.9 Years STANDARD_DEVIATION 12.5 • n=74 Participants	53.6 Years STANDARD_DEVIATION 12.4 • n=175 Participants
Sex: Female, Male Female	188 Participants n=37 Participants	135 Participants n=37 Participants	136 Participants n=74 Participants	459 Participants n=175 Participants
Sex: Female, Male Male	1 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	1 Participants n=175 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=37 Participants	33 Participants n=37 Participants	19 Participants n=74 Participants	78 Participants n=175 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	137 Participants n=37 Participants	79 Participants n=37 Participants	102 Participants n=74 Participants	318 Participants n=175 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	26 Participants n=37 Participants	23 Participants n=37 Participants	15 Participants n=74 Participants	64 Participants n=175 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=37 Participants	0 Participants n=37 Participants	2 Participants n=74 Participants	5 Participants n=175 Participants
Race (NIH/OMB) Asian	39 Participants n=37 Participants	29 Participants n=37 Participants	30 Participants n=74 Participants	98 Participants n=175 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	1 Participants n=175 Participants
Race (NIH/OMB) Black or African American	6 Participants n=37 Participants	5 Participants n=37 Participants	2 Participants n=74 Participants	13 Participants n=175 Participants
Race (NIH/OMB) White	112 Participants n=37 Participants	70 Participants n=37 Participants	84 Participants n=74 Participants	266 Participants n=175 Participants
Race (NIH/OMB) More than one race	7 Participants n=37 Participants	14 Participants n=37 Participants	7 Participants n=74 Participants	28 Participants n=175 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=37 Participants	17 Participants n=37 Participants	11 Participants n=74 Participants	49 Participants n=175 Participants

PRIMARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=136 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Progression-Free Survival (PFS)	5.5 Months Interval 4.2 to 8.3	5.6 Months Interval 4.3 to 6.9

PRIMARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=136 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Overall Survival (OS)	25.1 Months Interval 18.3 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	23.4 Months Interval 15.8 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis populations included all randomized participants with a CPS ≥10

PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Only participants with a CPS ≥10 were included in this analysis. PFS is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=65 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=65 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Progression-Free Survival (PFS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors With a Combined Positive Score (CPS) ≥10	5.7 Months Interval 2.9 to 13.9	5.7 Months Interval 3.8 to 7.6

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants with a CPS ≥10

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Only participants with a CPS ≥10 were included in this analysis.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=65 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=65 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Overall Survival (OS) in Participants With PD-L1 Positive Tumors With a CPS ≥10	NA Months Interval 17.0 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 15.5 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants with BRCAm tumors

PFS was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters (SOD) of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Only participants with BRCAm-positive tumors were included in this analysis. PFS is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors	12.4 Months Interval 8.3 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	8.4 Months Interval 5.4 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants with BRCAm tumors

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Only participants with BRCAm-positive tumors were included in this analysis.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
OS in Participants With BRCAm Tumors	NA Months Interval 17.1 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	23.4 Months Interval 17.3 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Combined Score	-5.82 Score on a Scale Interval -9.03 to -2.61	-2.54 Score on a Scale Interval -5.71 to 0.64

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score	-2.86 Score on a Scale Interval -6.29 to 0.57	-2.69 Score on a Scale Interval -6.09 to 0.7

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 4 questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in emotional functioning (EORTC QLQ-C30 Items 21-24) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score	-0.46 Score on a Scale Interval -4.3 to 3.38	-2.53 Score on a Scale Interval -6.32 to 1.25

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30, consisting of functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All, 4=Very Much). Using linear transformation, raw scores are standardized, so scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific QoL Questionnaire (EORTC QLQ-BR23) Items 1-4, 6, 7, and 8 Score	-0.91 Score on a Scale Interval -3.27 to 1.44	-1.84 Score on a Scale Interval -4.17 to 0.48

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

The EQ-5D-5L is a questionnaire developed to assess health-related outcomes. The VAS is a component of the EQ-5D-5L that asks participants to rate their overall health on a vertical visual analogue scale, with the scale's ends labelled 'The best health you can imagine' (equivalent to a score of 0) and 'The worst health you can imagine' (equivalent to a score of 100). The change from baseline in VAS score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1) and BRCA status at randomization (BRCAm vs. BRCAwt)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Visual Analogue Scale (VAS) Score on the European Quality of Life 5-dimension, 5-level Questionnaire (EQ-5D-5L)	-2.74 Score on a Scale Interval -5.36 to -0.12	-2.37 Score on a Scale Interval -4.97 to 0.24

SECONDARY outcome

Timeframe: Baseline and up to 18 weeks

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Combined Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors	-4.85 Score on a Scale Interval -12.43 to 2.73	-3.51 Score on a Scale Interval -11.17 to 4.15

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors	4.12 Score on a Scale Interval -0.68 to 8.92	-0.70 Score on a Scale Interval -5.62 to 4.21

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 4 questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. The change from baseline in emotional functioning (EORTC QLQ-C30 Items 21-24) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors	-1.50 Score on a Scale Interval -8.41 to 5.41	-4.02 Score on a Scale Interval -11.15 to 3.11

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30, consisting of functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All, 4=Very Much). Using linear transformation, raw scores are standardized, so scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors	-4.27 Score on a Scale Interval -8.27 to -0.27	-2.67 Score on a Scale Interval -6.77 to 1.43

SECONDARY outcome

Timeframe: Baseline and week 18

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed at least one assessment for this outcome.

The EQ-5D-5L is a questionnaire developed to assess health-related outcomes. The VAS is a component of the EQ-5D-5L that asks participants to rate their overall health on a vertical visual analogue scale, with the scale's ends labelled 'The best health you can imagine' (equivalent to a score of 0) and 'The worst health you can imagine' (equivalent to a score of 100). The change from baseline in VAS score was calculated based on a cLDA model with scores as response variable with covariates for treatment by time interaction, stratification factors (response at randomization (CR/PR vs. SD), and baseline CPS for PD-L1 expression (PD-L1 CPS\<1 vs. PD-L1 CPS≥1)) as covariates.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Change From Baseline in Visual Analogue Scale (VAS) Score on the EQ-5D-5L in Participants With BRCAm Tumors	1.73 Score on a Scale Interval -3.08 to 6.54	-3.83 Score on a Scale Interval -8.77 to 1.11

SECONDARY outcome

Timeframe: Baseline and up to approximately 29 months

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Time to Deterioration (TTD) in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score	10.3 Months Interval 4.2 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 13.2 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 4 questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in emotional functioning Items 21-24 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 14.5 to NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in systemic therapy side effects Items 1-4, 6, 7 and 8 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=134 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=132 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Baseline and up to approximately 29 months

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
TTD in Health-Related QoL Using the EORTC QLQ-C30 Items 29 and 30 Score in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors	7.9 Months Interval 3.7 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 3.5 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score in Participants With BRCAm Tumors	NA Months Interval 10.4 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to 4 questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD was defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in emotional functioning Items 21-24 scale scores. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
TTD in Emotional Functioning Using the EORTC QLQ-C30 Items 21-24 Score in Participants With BRCAm Tumors	NA Months Interval 7.9 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months Interval 15.4 to NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants with BRCAm tumors, who received ≥1 dose of study treatment and who completed the baseline assessment for this outcome.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=29 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=30 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
TTD in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 Items 1-4, 6, 7, and 8 Score in Participants With BRCAm Tumors	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	NA Months NA = Median, lower limit, and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants who received ≥1 dose of study drug and who had at least 1 laboratory or vital sign measurement.

An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience at least 1 AE is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=133 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Number of Participants Who Experienced At Least One Adverse Event (AE)	126 Participants	130 Participants

SECONDARY outcome

Timeframe: Up to approximately 29 months

Population: The analysis population included all randomized participants who received ≥1 dose of study drug and who had at least 1 laboratory or vital sign measurement.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Olaparib n=135 Participants This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle plus olaparib 300 mg orally twice daily during the post-induction period.	Pembrolizumab + Carboplatin + Gemcitabine n=133 Participants This arm includes participants who randomized following completion of the induction period. Participants continued to receive both carboplatin AUC 2 with gemcitabine 1000 mg/m\^2 intravenously on Days 1 and 8 of each 21-day cycle in addition to pembrolizumab 200 mg intravenously on Day 1 of each 21-day cycle in the post-induction period.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	15 Participants	28 Participants

Adverse Events

Pembrolizumab + Carboplatin + Gemcitabine Induction Treatment

Serious events: 80 serious events

Other events: 456 other events

Deaths: 124 deaths

Pembrolizumab + Olaparib

Serious events: 35 serious events

Other events: 121 other events

Deaths: 50 deaths

Pembrolizumab + Carboplatin + Gemcitabine

Serious events: 32 serious events

Other events: 128 other events

Deaths: 54 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 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