학술논문
Four-year clinical update and treatment switching-adjusted outcomes with first-line nivolumab plus ipilimumab with chemotherapy for metastatic non-small cell lung cancer in the CheckMate 9LA randomized trial
Document Type
article
Author
Enriqueta Felip; David P. Carbone; Martin Reck; Luis Paz-Ares; Yong Yuan; Nan Hu; Niels Reinmuth; Xiaoqing Zhang; Thomas John; Ying Cheng; Shun Lu; Manuel Cobo; Michael Schenker; Tudor-Eliade Ciuleanu; Stéphanie Bordenave; Oscar Juan-Vidal; Juliana Menezes; Eduardo Richardet; Hideaki Mizutani; Bogdan Zurawski; Aurelia Alexandru; Javed Mahmood; Tuli De; Irene Santi; John R. Penrod; Adam Lee
Source
Journal for ImmunoTherapy of Cancer, Vol 12, Iss 2 (2024)
Subject
Language
English
ISSN
2051-1426
Abstract
Background In CheckMate 9LA, nivolumab plus ipilimumab with chemotherapy prolonged overall survival (OS) versus chemotherapy regardless of tumor PD-L1 expression or histology. We report updated efficacy and safety in all randomized patients with a minimum 4-year follow-up and an exploratory treatment-switching adjustment analysis in all treated patients who received chemotherapy and subsequent immunotherapy.Methods Adults with stage IV/recurrent non-small cell lung cancer (NSCLC), no sensitizing EGFR/ALK alterations, and ECOG performance status ≤1 were randomized 1:1 to nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg every 6 weeks with chemotherapy (two cycles) or chemotherapy (four cycles, with optional maintenance pemetrexed for the nonsquamous population). Assessments included OS, progression-free survival, and objective response rate. Exploratory analyses included efficacy by tumor PD-L1 expression and histology and in patients who discontinued nivolumab plus ipilimumab with chemotherapy due to treatment-related adverse events (TRAEs), and a treatment-switching adjustment analysis using inverse probability of censoring weighting.Results With a 47.9-month minimum follow-up for OS, nivolumab plus ipilimumab with chemotherapy continued to prolong OS over chemotherapy in all randomized patients (HR 0.74, 95% CI 0.63 to 0.87; 4-year OS rate: 21% versus 16%), regardless of tumor PD-L1 expression (HR (95% CI): PD-L1