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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Thursday, May 30, 2024
Based on the results of a prespecified interim analysis of the phase III CheckMate 77T trial, which were recently published in The New England Journal of Medicine, the addition of perioperative immunotherapy with the PD-1 inhibitor nivolumab to neoadjuvant platinum-doublet chemotherapy significantly prolonged the duration of event-free survival in patients with resectable non–small cell lung cancer (NSCLC). Tina Cascone, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported no unexpected safety signals with this regimen.
Patients with stage IIA to IIIB disease were randomly assigned in a 1:1 ratio to receive neoadjuvant nivolumab plus chemotherapy (n = 229) or chemotherapy plus a placebo (n = 232) every 3 weeks for four cycles, followed by definitive surgery and either adjuvant nivolumab or a placebo every 4 weeks for 1 year. Follow-up data were provided for a median of 25.4 months.
The 18-month event-free survival rates were 70.2% and 50.0% with the perioperative nivolumab-based regimen and neoadjuvant chemotherapy alone, respectively (hazard ratio for disease progression or recurrence, abandoned surgery, or death = 0.58; P < .001). More patients achieved pathologic complete (25.3% vs 4.7%; odds ratio [OR] = 6.64) and major pathologic (35.4% vs 12.1%; OR = 4.01) responses with nivolumab vs chemotherapy alone. Treatment-related adverse events of grade 3 or 4 were reported in 32.5% of patients treated with nivolumab and in 25.2% of those who received chemotherapy alone.
“I am enthusiastic about the initial findings of the study,” Dr. Cascone commented in an institutional press release. “Looking ahead, it will be critical to identify patient and disease characteristics that will tell us who can potentially be cured with neoadjuvant chemoimmunotherapy only and who will benefit from more intensified treatment strategies.”
Disclosure: For full disclosures of the study authors, visit nejm.org.
The New England Journal of Medicine
