ASCO20: Immunotherapy Combination Plus Chemotherapy for Advanced NSCLC
Posted: Monday, June 8, 2020
In patients with stage IV or recurrent non–small cell lung cancer (NSCLC), first-line treatment with nivolumab plus ipilimumab and a limited course of chemotherapy significantly improved overall survival compared with chemotherapy alone—meeting the primary endpoint of the phase III CheckMate 9LA trial. Martin Reck, MD, PhD, of the German Center for Lung Research, and colleagues presented their findings during the ASCO20 Virtual Scientific Program (Abstract 9501).
In this study, patients with treatment-naive stage IV or recurrent NSCLC were randomly assigned to receive either two cycles of nivolumab plus ipilimumab and two cycles of a platinum-doublet chemotherapy (n = 361) or four cycles of chemotherapy alone (n = 358). The choice of chemotherapy was based on tumor histology, and patients with nonsquamous NSCLC in the chemotherapy-alone arm could receive optional pemetrexed maintenance. The study included patients with an Eastern Cooperative Oncology Group performance status 0 to 1 and no known sensitizing EGFR/ALK alterations.
At a preplanned interim analysis—with a minimum follow-up of 8.1 months—overall survival was significantly longer in the nivolumab-plus-ipilimumab arm compared with the chemotherapy-alone arm (P = .0006); after a minimum follow-up of 12.7-months, nivolumab plus ipilimumab and chemotherapy continued to prolong overall survival (15.6 vs. 10.9 months). The 1-year survival rates with nivolumab plus ipilimumab and chemotherapy alone were 63% and 47%, respectively. Clinical benefit was consistent in key subgroups, including based on expression of PD-L1 and histology.
As for safety, grade 3 and 4 treatment-related adverse events were reported in 47% and 38%, respectively, of patients treated with nivolumab plus ipilimumab and chemotherapy alone. No new safety signals were reported.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
