KEYNOTE-042 — Pembrolizumab Versus Platinum-Based Chemotherapy in PD-L1-Positive Advanced NSCLC

Phase 3 · 2019 · Non-Small Cell Lung Cancer

Design

Randomized pembrolizumab monotherapy vs platinum-based chemotherapy across PD-L1 TPS >=1% strata.

Population

Untreated locally advanced/metastatic NSCLC with PD-L1 TPS >=1%, no EGFR/ALK alterations.

Primary Endpoint

overall survival (OS) in TPS >=50%, >=20%, and >=1%

Key Result

OS benefit HR 0.81 in TPS >=1% (median 16.7 vs 12.1 mo), driven largely by the TPS >=50% subgroup (HR 0.69).

Guideline Impact

Supports first-line pembrolizumab monotherapy for PD-L1-positive NSCLC