RT Journal Article
T1 First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 4-Year Outcomes From the Randomized, Open-Label, Phase 3 CheckMate 227 Part 1 Trial.
A1 Paz-Ares, Luis G
A1 Ramalingam, Suresh S
A1 Ciuleanu, Tudor-Eliade
A1 Lee, Jong-Seok
A1 Urban, Laszlo
A1 Caro, Reyes Bernabe
A1 Park, Keunchil
A1 Sakai, Hiroshi
A1 Ohe, Yuichiro
A1 Nishio, Makoto
A1 Audigier-Valette, Clarisse
A1 Burgers, Jacobus A
A1 Pluzanski, Adam
A1 Sangha, Randeep
A1 Gallardo, Carlos
A1 Takeda, Masayuki
A1 Linardou, Helena
A1 Lupinacci, Lorena
A1 Lee, Ki Hyeong
A1 Caserta, Claudia
A1 Provencio, Mariano
A1 Carcereny, Enric
A1 Otterson, Gregory A
A1 Schenker, Michael
A1 Zurawski, Bogdan
A1 Alexandru, Aurelia
A1 Vergnenegre, Alain
A1 Raimbourg, Judith
A1 Feeney, Kynan
A1 Kim, Sang-We
A1 Borghaei, Hossein
A1 O'Byrne, Kenneth John
A1 Hellmann, Matthew D
A1 Memaj, Arteid
A1 Nathan, Faith Ellen
A1 Bushong, Judith
A1 Tran, Phuong
A1 Brahmer, Julie R
A1 Reck, Martin
K1 CTLA-4
K1 First-line
K1 Immunotherapy
K1 Metastatic non–small cell lung cancer
K1 PD-1 checkpoint inhibitor
AB 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.
YR 2021
FD 2021-10-12
LK http://hdl.handle.net/10668/22342
UL http://hdl.handle.net/10668/22342
LA en
DS RISalud
RD Apr 6, 2025