Journal Article

Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer

Martin, Claudio, Kerr, Keith, Ito, Hiroyuki, Wang, Lily, Provencio, Mariano, Brahmer, Julie R., Forde, Patrick M., Taube, Janis M., Spicer, Jonathan D., Awad, Mark M., Tanaka, Fumihiro, Duong, Quyen, Fiore, Joseph, Broderick, Stephen, Cai, Junliang, Girard, Nicolas, Swanson, Scott J., Saylors, Gene B., Felip, Enriqueta, Bhatia, Sumeena, Wang, Changli, Liberman, Moishe, Chen, Ke-Neng, Meadows-Shropshire, Stephanie, Mitsudomi, Tetsuya, Lu, Shun, Ciuleanu, Tudor-Eliade

2025

Overview

Neoadjuvant nivolumab plus chemotherapy significantly improved pathological complete response and event-free survival in patients with resectable non-small-cell lung cancer (NSCLC) in a phase 3 trial. Data are needed on overall survival. In this open-label, phase 3 trial, patients with stage IB to IIIA resectable NSCLC were randomly assigned to receive nivolumab plus chemotherapy or chemotherapy alone for three cycles, followed by surgery. The primary end points were event-free survival and pathological complete response. Here, we report the results of the planned analysis of overall survival. A total of 358 patients were concurrently assigned to receive nivolumab plus chemotherapy (179 patients) or chemotherapy alone (179 patients). The final analysis of overall survival significantly favored neoadjuvant nivolumab plus chemotherapy over chemotherapy (hazard ratio for death, 0.72; 95% confidence interval [CI], 0.523 to 0.998; P = 0.048). At a median follow-up of 68.4 months, the 5-year overall survival was 65.4% with nivolumab plus chemotherapy and 55.0% with chemotherapy alone, with consistency across most subgroups. In exploratory analyses, the 5-year overall survival in the nivolumab-plus-chemotherapy group was 95.3% (95% CI, 82.7 to 98.8) among the patients with a pathological complete response and 55.7% (95% CI, 46.9 to 63.7) among those without such a response; survival was 75.0% among the patients with presurgery clearance of circulating tumor DNA (ctDNA) and 52.6% among those without such clearance. No new safety signals were observed. Three cycles of neoadjuvant nivolumab plus chemotherapy significantly improved overall survival among patients with resectable NSCLC as compared with chemotherapy alone. (Funded by Bristol Myers Squibb; CheckMate 816 ClinicalTrials.gov number, NCT02998528.).

• Publisher: Massachusetts Medical Society
• Subject: Adult / Aged / Aged, 80 and over / Antineoplastic Combined Chemotherapy Protocols - administration & dosage / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Cancer therapies / Carcinoma, Non-Small-Cell Lung - drug therapy / Carcinoma, Non-Small-Cell Lung - mortality / Carcinoma, Non-Small-Cell Lung - surgery / Chemotherapy / Chemotherapy, Adjuvant - adverse effects / Chemotherapy, Adjuvant - methods / Committees / Critical Care / Critical Care General / Female / Follow-Up Studies / Hematology / Humans / Hypothesis testing / Immune Checkpoint Inhibitors - administration & dosage / Immune Checkpoint Inhibitors - adverse effects / Immunotherapy / Lung Cancer / Lung Neoplasms - drug therapy / Lung Neoplasms - mortality / Lung Neoplasms - surgery / Male / Middle Aged / Missing data / Neoadjuvant Therapy - adverse effects / Neoadjuvant Therapy - methods / Neoplasm Staging / Nivolumab - administration & dosage / Nivolumab - adverse effects / Non-small cell lung carcinoma / Oncology / Pathologic Complete Response / Patients / Pneumonectomy / Pulmonary / Small cell lung carcinoma / Survival Analysis / Survival Rate / Time Factors / Treatments in Oncology