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Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma

Christian U Blank, Minke W Lucas, Richard A Scolyer, et al. N Engl J Med. 2024 Nov 7;391(18):1696-1708

In phase 1-2 trials in patients with resectable, macroscopic stage III melanoma, neoadjuvant immunotherapy was more efficacious than adjuvant immunotherapy. A total of 423 patients underwent randomization. At a median follow-up of 9.9 months, the estimated 12-month event-free survival was 83.7% in the neoadjuvant group and 57.2% in the adjuvant group. The difference in restricted mean survival time was 8.00 months (P50% residual viable tumor), and 2.4% had progression. The estimated 12-month recurrence-free survival was 95.1% in patients in the neoadjuvant group who had a major pathological response, 76.1% among those with a partial response, and 57.0% among those with a nonresponse. Adverse events of grade 3 or higher that were related to systemic treatment occurred in 29.7% of patients in the neoadjuvant group and in 14.7% in the adjuvant group.Among patients with resectable, macroscopic stage III melanoma, neoadjuvant ipilimumab plus nivolumab followed by surgery and response-driven adjuvant therapy resulted in longer event-free survival than surgery followed by adjuvant nivolumab.

24 Mar, 2026