KEYNOTE-189 — Pemetrexed and Platinum Chemotherapy With or Without Pembrolizumab in Metastatic Nonsquamous NSCLC

Phase 3 · 2018 · Non-Small Cell Lung Cancer

Design

Randomized 2:1 to pemetrexed-platinum plus pembrolizumab or placebo, with crossover allowed.

Population

Untreated metastatic nonsquamous NSCLC without EGFR/ALK alterations, any PD-L1.

Primary Endpoint

overall survival (OS) and progression-free survival (PFS)

Key Result

OS HR 0.56 (median 22.0 vs 10.7 mo); PFS HR 0.48 (9.0 vs 4.9 mo); benefit across all PD-L1 strata.

Guideline Impact

NCCN category 1 first-line for nonsquamous NSCLC without driver mutations