Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer.

Abstract (PubMed)

First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a PD-L1 tumor proportion score of 50% or greater, pembrolizumab monotherapy has replaced chemotherapy as first-line standard of care. In this randomized, double-blind, phase 3 trial (KEYNOTE-189), we compared pembrolizumab plus platinum-based chemotherapy (pemetrexed plus cisplatin or carboplatin) with placebo plus chemotherapy in patients with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK mutations. The primary end points were overall survival (OS) and progression-free survival (PFS). A total of 616 patients were randomized 2:1 to pembrolizumab+chemotherapy vs placebo+chemotherapy. OS at 12 months was 69.2% vs 49.4% (HR 0.49; 95% CI 0.38–0.64; P<0.001). PFS was 8.8 months vs 4.9 months (HR 0.52; 95% CI 0.43–0.64; P<0.001). Pembrolizumab plus chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone in patients with metastatic nonsquamous NSCLC.