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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Wednesday, September 10, 2025
According to Patrick M. Forde, MB, BCh, PhD, of Trinity St. James’s Cancer Institute, Trinity College Dublin, and colleagues, the addition of the PD-1 inhibitor nivolumab to neoadjuvant chemotherapy significantly prolonged overall survival in patients with resectable non–small cell lung cancer (NSCLC). The results of the planned overall survival analysis of the phase III CheckMate 816 trial were published in The New England Journal of Medicine.
“On the basis of the [event-free survival and pathologic complete response] findings from this trial, nivolumab plus chemotherapy is the sole neoadjuvant-only chemoimmunotherapy regimen approved for patients with resectable NSCLC in the United States, European Union, and several other jurisdictions,” the investigators commented. However, they also acknowledged that “data are needed on overall survival,” prompting the present analysis.
A total of 358 patients with stage IB to IIIA resectable NSCLC were randomly assigned in a 1:1 ratio to receive nivolumab plus chemotherapy or chemotherapy alone for three cycles, followed by surgery. The final overall survival results appeared to significantly favor neoadjuvant nivolumab plus chemotherapy (hazard ratio for death = 0.72; P = .048). With a median follow-up of 68.4 months, the 5-year overall survival rate was 65.4% with nivolumab plus chemotherapy and 55.0% with chemotherapy alone; consistent results were observed across most subgroups.
Exploratory analyses revealed 5-year overall survival rates of 95.3% and 55.7% in those with and without a pathologic complete response, respectively, in the nivolumab-plus-chemotherapy group. The overall survival rate was 75.0% in patients with clearance of circulating tumor DNA before surgery and 52.6% in those without. No new safety signals were reported.
“These findings support the hypothesis that neoadjuvant chemoimmunotherapy can have a profound effect on the course of a patient’s life when paired with the curative potential of surgical resection,” the investigators concluded.
Disclosure: For full disclosures of the study authors, visit nejm.org.
The New England Journal of Medicine
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