ASCO 2024: Neoadjuvant immunotherapy in resectable stage III melanoma

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 (EFS) than surgery followed by adjuvant nivolumab.

In the phase 3 NADINA trial, 423 patients with resectable, macroscopic stage III melanoma were randomized in a 1:1 ratio to receive two cycles of neoadjuvant ipilimumab plus nivolumab and then undergo surgery (n = 212) or to undergo surgery and then receive 12 cycles of adjuvant nivolumab (n = 211). Patients in the neoadjuvant group who had a partial response or nonresponse received subsequent adjuvant treatment.

At a median follow-up of 9.9 months, estimated 12-month EFS was 83.7% in the neoadjuvant group vs. 57.2% in the adjuvant group. Difference in restricted mean survival time was 8.00 months (hazard ratio for progression, recurrence, or death, 0.32; 99.9% confidence interval, 0.15-0.66). In the neoadjuvant group, 59.0% of participants had a major pathological response (MPR), 8.0% had a partial response (PR), 26.4% had a nonresponse (NR; >50% residual viable tumor), and 2.4% had progression. Estimated 12-month recurrence-free survival was 95.1% among those in the neoadjuvant group who had MPR, 76.1% among those who had PR, and 57.0% among those who had NR. Rates of adverse events of grade 3 or higher that were related to systemic treatment were 29.7% in the neoadjuvant group vs. 14.7% in the adjuvant group.

Source:

Blank CU, et al. (2024, June 2). N Engl J Med. Neoadjuvant Nivolumab and Ipilimumab in Resectable Stage III Melanoma. https://pubmed.ncbi.nlm.nih.gov/38828984/