KEYNOTE-355 — Pembrolizumab Plus Chemotherapy Versus Chemotherapy for Metastatic Triple-Negative Breast Cancer

Phase 3 · 2020 · Breast Cancer

Design

Randomized 2:1 to chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin) plus pembrolizumab or placebo.

Population

Untreated locally recurrent inoperable or metastatic triple-negative breast cancer.

Primary Endpoint

progression-free survival (PFS) and overall survival (OS) in PD-L1 CPS >=10

Key Result

In CPS >=10: PFS 9.7 vs 5.6 mo (HR 0.65) and OS 23.0 vs 16.1 mo (HR 0.73).

Guideline Impact

NCCN category 1 first-line for PD-L1 CPS >=10 metastatic TNBC