Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer

作者：Matthew D. Hellmann, Luis Paz‐Ares, Reyes Bernabe Caro, Bogdan Żurawski, Sang‐We Kim, Enric Carcereny, Keunchil Park, Aurelia Alexandru, Lorena Lupinacci, Emmanuel de la Mora Jimenez, Hiroshi Sakai, István Albert, A. Vergnenègre, Solange Peters, Konstantinos Syrigos, Fabrice Barlési, Martin Reck, Hossein Borghaei, Julie R. Brahmer, Kenneth J. O’Byrne, William J. Geese, Prabhu Bhagavatheeswaran, Sridhar K. Rabindran, Ravi S. Kasinathan, Faith E. Nathan, Suresh S. Ramalingam · 发表于：New England Journal of Medicine · 年份：2019 · DOI：10.1056/nejmoa1910231 · 被引用次数：2894 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Diagnosis and Treatment、Immunotherapy and Immune Responses

BACKGROUND: In an early-phase study involving patients with advanced non-small-cell lung cancer (NSCLC), the response rate was better with nivolumab plus ipilimumab than with nivolumab monotherapy, particularly among patients with tumors that expressed programmed death ligand 1 (PD-L1). Data are needed to assess the long-term benefit of nivolumab plus ipilimumab in patients with NSCLC. METHODS: In this open-label, phase 3 trial, we randomly assigned patients with stage IV or recurrent NSCLC and a PD-L1 expression level of 1% or more in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab alone, or chemotherapy. The patients who had a PD-L1 expression level of less than 1% were randomly assigned in a 1:1:1 ratio to receive nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy alone. All the patients had received no previous chemotherapy. The primary end point reported here was overall survival with nivolumab plus ipilimumab as compared with chemotherapy in patients with a PD-L1 expression level of 1% or more. RESULTS: Among the patients with a PD-L1 expression level of 1% or more, the median duration of overall survival was 17.1 months (95% confidence interval [CI], 15.0 to 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI, 12.7 to 16.7) with chemotherapy (P = 0.007), with 2-year overall survival rates of 40.0% and 32.8%, respectively. The median duration of response was 23.2 months with nivolumab plus ipilimumab and 6.2 months with chemot...