Phase 3
Completed N=622
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
Source: ClinicalTrials.gov NCT02555657 ↗Enrolled (actual)
622
Serious AEs
20.7%
Results posted
May 2020
Primary outcomePrimary: Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10 — 12.7; 11.6 Months — p=0.0574
Summary
In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival compared to TPC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10 |
12.7; 11.6 | 0.0574 |
| PRIMARY Overall Survival in Participants With PD-L1 CPS ≥1 |
10.7; 10.2 | 0.0728 |
| PRIMARY Overall Survival in All Participants |
9.9; 10.8 | 0.3802 |
| SECONDARY Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10 |
17.7; 9.2 | 0.0457 sig |
| SECONDARY Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 |
12.3; 9.4 | 0.1752 |
| SECONDARY Overall Response Rate Per RECIST 1.1 in All Participants |
9.6; 10.6 | 0.6629 |
| SECONDARY Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 |
2.1; 3.4 | 0.7936 |
| SECONDARY Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 |
2.1; 3.1 | 0.9964 |
| SECONDARY Progression-Free Survival Per RECIST 1.1 in All Participants |
2.1; 3.3 | 1.0000 |
| SECONDARY Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response |
NA; 7.1 | — |
| SECONDARY Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response |
12.2; NA | — |
| SECONDARY Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response |
12.2; NA | — |
| SECONDARY Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 |
19.8; 17.3 | 0.3388 |
| SECONDARY Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 |
14.3; 15.8 | 0.6701 |
| SECONDARY Disease Control Rate Per RECIST 1.1 in All Participants |
12.2; 18.7 | 0.9877 |
| SECONDARY Number of Participants Who Experienced One or More Adverse Events |
285; 281 | — |
| SECONDARY Number of Participants Who Discontinued Study Treatment Due to an Adverse Event |
14; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Centrally confirmed Stage IV/M1 mTNBC
- Newly obtained tumor biopsy from metastatic site
- Central determination of programmed cell death ligand 1 (PD-L1) tumor status
- Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
- Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
- Adequate organ function
Exclusion Criteria
- Participation in another clinical trial within 4 weeks
- Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks
- Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks
- Active autoimmune disease that required systemic treatment in the past 2 years
- Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days
- Known additional malignancy that required treatment or progressed in last 5 years
- Known active brain metastases and/or carcinomatous meningitis
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1 (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40, CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies
Data sourced from ClinicalTrials.gov (NCT02555657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.