Pembrolizumab Plus Pemetrexed-Platinum for Metastatic Nonsquamous Non-Small-Cell Lung Cancer: KEYNOTE-189 Japan Study.

Pembrolizumab plus pemetrexed-platinum significantly improved overall survival (OS) and progression-free survival (PFS) with manageable safety versus placebo plus pemetrexed-platinum in patients with previously untreated metastatic nonsquamous non-small-cell lung cancer (NSCLC) without EGFR/ALK alterations in the global, randomized, double-blind, phase 3 KEYNOTE-189 study. We present results of Japanese patients enrolled in the KEYNOTE-189 global and Japan extension studies. Patients were randomized 2:1 to intravenous pembrolizumab 200 mg or placebo every 3 weeks (Q3W) for up to 35 cycles. All patients received pemetrexed 500 mg/m2 plus investigator's choice of cisplatin or carboplatin Q3W for 4 cycles, followed by maintenance pemetrexed 500 mg/m2 Q3W (all intravenous). Co-primary endpoints were OS and PFS. Forty Japanese patients enrolled (pembrolizumab, n=25; placebo, n=15). At data cutoff (May 20, 2019; median time from randomization to data cutoff, 18.5 [range, 14.7-38.2] months), median OS was not reached in the pembrolizumab plus pemetrexed-platinum arm versus 25.9 (95% CI, 11.9-29.0) months in the placebo plus pemetrexed-platinum arm (hazard ratio [HR] 0.29; 95% CI, 0.07-1.15). Median (95% CI) PFS was 16.5 (8.8-21.1) versus 7.1 (4.7-21.4) months (HR, 0.62; 95% CI, 0.27-1.42). There were no grade 5 adverse events (AEs). Grade 3/4 AEs occurred in 72% versus 60% of patients in the pembrolizumab versus placebo arms; 40% versus 20% had immune-mediated AEs, and 4% versus 0% had infusion reactions. Efficacy and safety outcomes were similar to those from the global study and support first-line therapy with pembrolizumab plus pemetrexed-platinum in Japanese patients with nonsquamous NSCLC without EGFR/ALK alterations. This article is protected by copyright. All rights reserved.

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