Nivolumab plus ipilimumab with chemotherapy as first-line treatment of patients with metastatic non-small-cell lung cancer: final, 6-year outcomes from CheckMate 9LA

BACKGROUND: The phase III CheckMate 9LA study demonstrated durable overall survival (OS) benefit with nivolumab plus ipilimumab with chemotherapy versus chemotherapy in patients with metastatic non-small-cell lung cancer (NSCLC). Here, we report final, 6-year efficacy and safety outcomes. PATIENTS AND METHODS: Treatment-naive adults with stage IV/recurrent NSCLC and no sensitizing EGFR/ALK alterations were randomized to nivolumab plus ipilimumab with chemotherapy (n = 361) or chemotherapy (n = 358). Assessments included OS, progression-free survival, objective response rate, and duration of response (DOR) in all randomized patients and subgroups, and OS by select somatic mutation status (KRAS, STK11, KEAP1, and TP53). RESULTS: With 68.6 months' minimum follow-up, nivolumab plus ipilimumab with chemotherapy demonstrated continued OS benefit versus chemotherapy (hazard ratio 0.74, 95% confidence interval 0.63-0.87, 6-year OS rates 16% versus 10%), regardless of tumor programmed death ligand 1 (PD-L1) expression (PD-L1 <1%, 20% versus 7%; PD-L1

• Carbone, D. P.
• Ciuleanu, T. E.
• Cobo, M.
• Schenker, M.
• Zurawski, B.
• Menezes, J.
• Richardet, E.
• Felip, E.
• Cheng, Y.
• Juan-Vidal, O.
• Alexandru, A.
• Mizutani, H.
• Reinmuth, N.
• Lu, S.
• Reck, M.
• John, T.
• Scherpereel, A.
• De Marchi, P.
• Aoyama, T.
• Sathyanarayana, P.
• Grootendorst, D. J.
• Hu, N.
• Ip, V.
• Hung, Y. H.
• Paz-Ares, L. G.