KEYNOTE-522 — Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy for Early Triple-Negative Breast Cancer

Phase 3 · 2020 · Breast Cancer

Design

Randomized 2:1 to neoadjuvant chemotherapy plus pembrolizumab vs placebo, followed by adjuvant pembrolizumab or placebo after surgery.

Population

Previously untreated stage II-III triple-negative breast cancer, regardless of PD-L1 status.

Primary Endpoint

pathologic complete response (pCR) and event-free survival (EFS)

Key Result

pCR 64.8% vs 51.2% (+13.6 points); EFS at 5 yr ~81.3% vs 72.3%, HR 0.63; OS benefit HR ~0.66.

Guideline Impact

NCCN category 1 for neoadjuvant/adjuvant stage II-III TNBC