Neoadjuvant Nivolumab Plus Chemotherapy Improves Survival for Patients With Resectable Non-Small Cell Lung Cancer
Updated results from the phase 3 CheckMate 816 trial demonstrated that the addition of nivolumab to neoadjuvant chemotherapy significantly improved survival among patients with resectable non-small cell lung cancer (NSCLC).
In this open-label trial, 358 patients with resectable, stage IB to IIIA NSCLC were randomized to receive 3 cycles of either nivolumab plus chemotherapy (n = 179) or chemotherapy alone (n = 179) followed by surgical resection. According to previously reported results, “neoadjuvant nivolumab plus chemotherapy significantly improved pathological complete response and event-free survival in patients with resectable NSCLC in a phase 3 trial,” stated Patrick Forde, Trinity St. James’s Cancer Institute, Dublin, Ireland, and coauthors. The primary end point here was overall survival (OS). A key secondary end point was safety.
At a median follow-up of 68.4 months, the 5-year OS rate was 65.4% in the nivolumab plus chemotherapy arm and 55% in the chemotherapy alone arm (hazard ratio [HR] 0.72; 95% confidence interval [CI], 0.523 to 0.998; P = .048). Among patients treated with nivolumab plus chemotherapy, the 5-year OS rate was 95.3% in patients with a pathological complete response and 55.7% in patients without a pathological complete response. Survival was 75% in patients with presurgery ctDNA clearance and 52.6% in patients without presurgery ctDNA clearance. Safety was consistent with prior findings.
“Three cycles of neoadjuvant nivolumab plus chemotherapy significantly improved overall survival among patients with resectable NSCLC as compared with chemotherapy alone,” concluded Dr Forde et al.
Source:
Forde PM, Spicer JD, Provencio M, et al. Overall survival with neoadjuvant nivolumab plus chemotherapy in lung cancer. N Engl J Med. Published online: June 2, 2025. doi: 10.1056/NEJMoa2502931
