%0 Journal Article
%A Paz-Ares, Luis G
%A Ramalingam, Suresh S
%A Ciuleanu, Tudor-Eliade
%A Lee, Jong-Seok
%A Urban, Laszlo
%A Caro, Reyes Bernabe
%A Park, Keunchil
%A Sakai, Hiroshi
%A Ohe, Yuichiro
%A Nishio, Makoto
%A Audigier-Valette, Clarisse
%A Burgers, Jacobus A
%A Pluzanski, Adam
%A Sangha, Randeep
%A Gallardo, Carlos
%A Takeda, Masayuki
%A Linardou, Helena
%A Lupinacci, Lorena
%A Lee, Ki Hyeong
%A Caserta, Claudia
%A Provencio, Mariano
%A Carcereny, Enric
%A Otterson, Gregory A
%A Schenker, Michael
%A Zurawski, Bogdan
%A Alexandru, Aurelia
%A Vergnenegre, Alain
%A Raimbourg, Judith
%A Feeney, Kynan
%A Kim, Sang-We
%A Borghaei, Hossein
%A O'Byrne, Kenneth John
%A Hellmann, Matthew D
%A Memaj, Arteid
%A Nathan, Faith Ellen
%A Bushong, Judith
%A Tran, Phuong
%A Brahmer, Julie R
%A Reck, Martin
%T First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 4-Year Outcomes From the Randomized, Open-Label, Phase 3 CheckMate 227 Part 1 Trial.
%D 2021
%U http://hdl.handle.net/10668/22342
%X In CheckMate 227, nivolumab plus ipilimumab prolonged overall survival (OS) versus chemotherapy in patients with tumor programmed death-ligand 1 (PD-L1) greater than or equal to 1% (primary end point) or less than 1% (prespecified descriptive analysis). We report results with minimum 4 years' follow-up. Adults with previously untreated stage IV or recurrent NSCLC were randomized (1:1:1) to nivolumab plus ipilimumab, nivolumab, or chemotherapy (PD-L1 ≥1%); or to nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1  After 54.8 months' median follow-up, OS remained longer with nivolumab plus ipilimumab versus chemotherapy in patients with PD-L1 greater than or equal to 1% (hazard ratio = 0.76; 95% confidence interval: 0.65-0.90) and PD-L1 less than 1% (0.64; 0.51-0.81); 4-year OS rate with nivolumab plus ipilimumab versus chemotherapy was 29% versus 18% (PD-L1 ≥1%); and 24% versus 10% (PD-L1  At more than 4 years' minimum follow-up, with all patients off immunotherapy treatment for at least 2 years, first-line nivolumab plus ipilimumab continued to demonstrate durable long-term efficacy in patients with advanced NSCLC. No new safety signals were identified. Immune-mediated AEs occurred early and resolved quickly with guideline-based management. Discontinuation of nivolumab plus ipilimumab due to TRAEs did not have a negative impact on the long-term benefits seen in all randomized patients.
%K CTLA-4
%K First-line
%K Immunotherapy
%K Metastatic non–small cell lung cancer
%K PD-1 checkpoint inhibitor
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