Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C.

9016Background: The anti–PD-1 antibody pembro exhibits robust antitumor activity in patients (pts) with advanced NSCLC. In cohorts A-C of KEYNOTE-021 (NCT02039674), we evaluated the efficacy and safety of pembro + various chemotherapy combinations in advanced NSCLC. Methods: Chemotherapy-naive, advanced, EGFR/ALK (-) NSCLC pts, PS 0 or 1, were randomly assigned to pembro 2 or 10 mg/kg Q3W plus either carboplatin AUC 6 + paclitaxel 200 mg/m2 (A, any histology), carboplatin AUC 6 + paclitaxel 200 mg/m2 + bevacizumab (BEV) 15 mg/kg (B, nonsquamous), or carboplatin AUC 5 + pemetrexed (PEM) 500 mg/m2(C, nonsquamous) for 4 cycles followed by maintenance pembro (A), pembro + BEV (B), or pembro + PEM (C). Response was assessed every 6 wk by central imaging vendor. Results: As of Dec 16, 2015, 74 pts (25 in A, 25 in B, and 24 in C) had been treated; median follow-up duration was 12 mo (A = 13; B = 9; C = 16). 1 DLT occurred in cycle 1 (gr 3 rash, C). Gr 3-4 treatment-related AEs occurred in 36%, 46%, and 42% of pt...