In an analysis from the phase III CheckMate 816 trial reported at the 2025 ASCO Annual Meeting and in The New England Journal of Medicine, Forde et al examined overall survival outcomes with the addition of neoadjuvant nivolumab to platinum-based chemotherapy in patients with stage IB to IIIA resectable non–small cell lung cancer (NSCLC).
Prior reports from the trial showed improved pathologic complete response rate and event-free survival with nivolumab plus chemotherapy.
Study Details
In the open-label international trial, 358 patients were randomly assigned between March 2017 and November 2019 to receive neoadjuvant nivolumab at 360 mg plus platinum-based chemotherapy (n = 179) or neoadjuvant platinum-based chemotherapy alone (n = 179) every 3 weeks for three cycles. The current report presents the planned final analysis of overall survival.
Key Findings
Median follow-up was 68.4 months. Overall survival was significantly improved with nivolumab plus chemotherapy vs chemotherapy alone (hazard ratio [HR] = 0.72, 95% confidence interval [CI] = 0.523–0.998, P = .048); 5-year overall survival was 65.4% (95% CI = 57.8%–71.9%) vs 55.0% (95% CI = 47.3%–62.0%).
At 5 years, the percentage of patients alive without disease progression or recurrence was 49.2% (95% CI = 40.8%–57.2%) vs 34.4% (95% CI = 26.8%–42.1; HR = 0.68, 95% CI = 0.51%–0.91%).
Exploratory analyses showed that 5-year overall survival in the nivolumab plus chemotherapy group was 95.3% (95% CI = 82.7%–98.8%) among patients with pathological complete response and 55.7% (95% CI, 46.9%–63.7%) among those without pathological complete response (HR = 0.11, 95% CI = 0.04%–0.36%). Among patients with major pathological response, 5-year overall survival was 86.3% (95% CI = 75.4%–92.6%) vs 52.8% (95% CI = 43.1%–61.6%) among those without major pathological response (HR = 0.23, 95% CI = 0.12%–0.45%). In addition, 5-year overall survival was 75.0% among patients with presurgery clearance of circulating tumor DNA and 52.6% among those without such clearance.
No new safety signals were reported.
The investigators concluded: “Three cycles of neoadjuvant nivolumab plus chemotherapy significantly improved overall survival among patients with resectable NSCLC as compared with chemotherapy alone.”
Patrick M. Forde, MB, BCh, of Trinity St. James’s Cancer Institute, Trinity College Dublin, is the corresponding author for the New England Journal of Medicine article.
Disclosure: The study was funded by Bristol Myers Squibb. For full disclosures of all study authors, visit The New England Journal of Medicine.
