417O Phase 3, randomized trial (CheckMate 057) of nivolumab vs docetaxel in advanced non-squamous (non-SQ) non-small cell lung cancer (NSCLC): subgroup analyses and patient reported outcomes (PROs)

Abstract

Background: Treatment options are limited for patients (pts) with advanced non-SQ NSCLC who progress after platinum-based doublet chemotherapy (PT-DC). DOC is approved for second-line treatment of advanced NSCLC; however, no single agent therapy has shown superior survival and improved tolerability vs DOC in this setting. We report results from a randomized, global phase 3 study of NIVO, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, vs DOC in pts with advanced non-SQ NSCLC after failure of PT-DC and tyrosine kinase inhibitor, if eligible. Methods: Pts were randomized to NIVO 3 mg/kg Q2W (n = 292) or DOC 75 mg/m2 Q3W (n = 290) until progression or discontinuation due to toxicity/ other reasons. Primary objective was OS; secondary objectives were investigator-assessed ORR (per RECIST v1.1), PFS, efficacy by PD-L1 expression, PROs, and safety. Results: NIVO improved OS (hazard ratio [HR]=0.73; 96% CI: 0.59, 0.89; P = 0.00155) and ORR (19.2% vs 12.4%; P = 0.0235) vs DOC. HR for PFS was 0.92 (95% CI: 0.77, 1.11; P = 0.393) (Table 1). Grade 3-5 treatment-related adverse events (AEs) occurred in 10.5% (30/287) of NIVO and 53.7% (144/268) of DOC pts. Treatment-related serious AEs (SAEs) were less frequent in the NIVO arm. Treatment-related AEs leading to discontinuation (DC) were more common with DOC vs NIVO (Table 2). No deaths were related to NIVO vs 1 DOC-related death. Additional subgroup analyses, including efficacy by tumor PD-L1 expression, and PROs, will be presented. Conclusions: NIVO significantly improved OS vs DOC in pts with advanced, previously-treated non-SQ NSCLC. The safety profile of NIVO 3 mg/kg Q2W was favorable vs DOC. NIVO demonstrated survival benefit across histologies in two randomized phase 3 trials. (Table Presented).