Primary results from Japanese phase I study of pembrolizumab plus chemotherapy as front-line therapy for advanced NSCLC

Abstract

Abstract Background The anti¯PD¯1 antibody pembrolizumab (pembro) exhibits robust antitumor activity in patients with advanced NSCLC. In part B¯C of KEYNOTE¯011 (NCT01905657), we evaluated the efficacy and safety of pembro + chemotherapy combinations in advanced NSCLC. Here we report primary results from both studies. This is the longest follow-up data on treatment of pembro plus standard chemotherapy regimens in Japanese NSCLC patients. Methods Chemotherapy-naive, advanced, EGFR/ALK (¯) NSCLC pts, PS 0 or 1, were treated to pembro plus either cisplatin or carboplatin + pemetrexed (PEM) (part B, non-squamous), or carboplatin and paclitaxel or nab-paclitaxel (part C, squamous) for 4 cycles followed by maintenance pembro + PEM (B), pembro (C). Results In part B, 12 pts (6 in cisplatin cohort, 6 in carboplatin cohort) had been treated; median (range) follow-up duration was 16.0 mo (3.7 ¯ 21.2 mo). 1 DLT occurred in cisplatin cohort (Grade 4 Hyponatremia) during the DLT evaluation period. At the time of data cutoff, ≥Gr 3 treatment-related AEs occurred in 75.0%, 2 treatment¯related death occurred (2 pneumonitis in carboplatin cohort). ORR was 66.7% and 80.0% in cisplatin and carboplatin cohort, respectively. ORR with cohorts combined in TPS ≥50%, TPS = 1¯49%, TPS Conclusions Pembro plus standard chemotherapy regimens is feasible and yields substantial clinical efficacy regardless of PD¯L1 status in treatment-naive advanced NSCLC. Detailed survival and safety will be presented.