Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis
Year: 2026
Type: article
Abstract: Individuals with non-small-cell lung cancer (NSCLC) with metastases to the ipsilateral mediastinum or subcarinal lymph nodes (N2 disease) have poor long-term survival. This exploratory analysis from the randomized phase 3 CheckMate 77T study assessed clinical outcomes by nodal status in individuals with stage III NSCLC who received neoadjuvant nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab (nivolumab) versus neoadjuvant chemotherapy followed by surgery and adjuvant placebo (placebo). Here we show that among patients with N2 disease, nivolumab versus placebo improved event-free survival (1-year rate, 70% versus 45%; hazard ratio, 0.46 (95% confidence interval, 0.30-0.70)) and pathological complete response rate (22.0% versus 5.6%); 77% versus 73% had definitive surgery, of whom 84% versus 74% received a simple lobectomy. Furthermore, nivolumab improved outcomes versus placebo in patients with multistation N2 NSCLC (1-year event-free survival rate: 71% versus 46%; hazard ratio, 0.43 (0.21-0.88); pathological complete response rate, 29.0% versus 2.7%). In the N2 subgroup with definitive surgery, 67% and 59% of patients had nodal downstaging after surgery (57% versus 44% downstaged to node-negative disease). Median EFS in randomized patients with stage III non-N2 NSCLC was not reached with nivolumab and 17.0 months with placebo (1-year EFS rate, 74% versus 62%; hazard ratio, 0.60 (0.33-1.08)). No new safety signals were identified. These findings support perioperative nivolumab plus neoadjuvant chemotherapy as an efficacious treatment for stage III N2 disease and suggest that N2 status may not predict poor prognosis in resectable NSCLC treated with perioperative immunotherapy. ClinicalTrials.gov identifier: NCT04025879 .
Source: Nature Cancer
Authors: Mariano Provencio, Mark M. Awad, Jonathan D. Spicer, Annelies Janssens, Fedor Moiseyenko, Yang Gao, Yasutaka Watanabe, Aurelia Alexandru, Florian Guisier, Nikolaj Frost, Fabio Franke, T. Jeroen Nicolaas Hiltermann, Jie He, Fumihiro Tanaka, Shun Lu, Cinthya Coronado Erdmann, Padma Sathyanarayana, Phuong Tran, Vipul Devas, Tina Cascone
Institutions: Hospital Universitario Puerta de Hierro Majadahonda, Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, McGill University Health Centre, Antwerp University Hospital, State Budget Institution of Health St. Petersburg Clinical Research Center Specialized Types of Medical Care, Xiangya Hospital Central South University, Saitama Cancer Center, Institutul Oncologic Bucuresti, Centre Hospitalier Universitaire de Rouen, Humboldt-Universität zu Berlin, Freie Universität Berlin, Charité - Universitätsmedizin Berlin, University Medical Center Groningen, University of Groningen, Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Hospital of Chinese Academy of Medical Sciences, University of Occupational and Environmental Health Japan, Shanghai Jiao Tong University, Shanghai Chest Hospital, Bristol-Myers Squibb (United States), The University of Texas MD Anderson Cancer Center
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $12,690
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Gilead Sciences, American Society of Clinical Oncology, F. Hoffmann-La Roche, Regeneron Pharmaceuticals, Taiho Pharmaceutical, Les Laboratories Pierre Fabre, Menarini Silicon Biosystems, BeiGene, Boehringer Ingelheim Japan, Apollomics, Yuhan, Moderna, European Commission, Eisai, Servier, Ono Pharmaceutical, Genentech, EMD Serono, Chugai Pharmaceutical, Takeda Oncology, Pfizer Canada, Eli Lilly Japan, Instituto de Salud Carlos III, Daiichi Sankyo Europe
OpenAlex ID: W7119035400