NIVOLUMAB + IPILIMUMAB + 2 CYCLES OF PLATINUM-DOUBLET CHEMOTHERAPY (CHEMO) VERSUS 4 CYCLES CHEMO AS FIRST-LINE TREATMENT FOR STAGE IV/ RECURRENT NON-SMALL CELL LUNG CANCER (NSCLC): CHECKMATE 9LA

Background: nivolumab+ipilimumab improved overall survival (OS) versus chemo in first-line advanced NSCLC in CheckMate 227 Part 1, regardless of PD-L1 expression. CheckMate 9LA (NCT03215706), a phase 3 randomized study, evaluates nivolumab+ipilimumab+chemo (2 cycles) versus chemo (4 cycles) in first-line advanced NSCLC. Methods: Adults with treatment-naive, stage IV/recurrent NSCLC were randomized to nivolumab 360mg Q3W + IPI 1mg/kg Q6W + chemo (2 cycles) (n=361) or chemo (4 cycles) alone (n=358), stratified by PD-L1 (<1% versus >1%), sex, and histology. Chemo was histology based. Primary endpoint: OS. Secondary end points: PFS and ORR (BICR), and efficacy by PD-L1 subgroups. Safety/tolerability was exploratory. Results: At a preplanned interim analysis (minimum follow-up 8.1months), OS was significantly prolonged with nivolumab+ipilimumab+chemo versus chemo (HR 0.69, 96.71%CI: 0.55 0.87; P=0.0006), as were PFS and ORR. With longer follow-up (minimum 12.7months), OS continued to favor nivolumab+ipilimumab+chemo versus chemo; median: 15.6 versus 10.9 months (HR 0.66, 95%CI: 0.55 0.80); 1-year OS rates: 63% versus 47%. Clinical benefit was consistent across all efficacy measures in key subgroups (PD-L1 and histology). Grade 3 4 TRAEs: 47% (nivolumab+ipilimumab+chemo) and 38% (chemo). Conclusions: OS was significantly improved with nivolumab+ipilimumab+chemo (2 cycles) versus chemo (4 cycles) in first-line advanced NSCLC, with no new safety signals. © 2020 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2020 ASCO Annual Meeting. All rights reserved.