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EU Panel Backs Frontline Pembrolizumab Combo for Nonsquamous NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Jul 30, 2018

Roger M. Perlmutter, MD, PhD

Roger M. Perlmutter, MD, PhD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of frontline pembrolizumab (Keytruda) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK mutations, regardless of PD-L1 expression.

The CHMP recommendation is based on the phase III KEYNOTE-189 trial, in which patients with nonsquamous NSCLC without EGFR or ALK mutations received frontline pembrolizumab or placebo in combination with pemetrexed (Alimta) and either cisplatin or carboplatin. At a median follow-up of 10.5 months, the estimated 12-month overall survival (OS) rate was 69.2% (95% CI, 64.1-73.8) in the pembrolizumab arm compared with 49.4% (95% CI, 42.1-56.2) in the control group (HR, 0.49; 95% CI, 0.38-0.64; P <.001).1,2
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