Retrospective study of real-world outcomes with neoadjuvant immunotherapy in melanoma patients

Based on outcomes observed in clinical trials, neoadjuvant therapy with immune checkpoint inhibitors (ICIs) is increasingly used in advanced or recurrent melanoma. The efficacy and toxicity of this strategy in a real-world setting are not yet clear. A retrospective review of adult patients with advanced, resectable cutaneous melanoma who received neoadjuvant ICIs at Memorial Sloan Kettering Cancer Center (New York, NY) investigated pathological response (PR, primary endpoint) and immune-related toxicity. Between 2019 and 2024, 81 patients received neoadjuvant ICIs. The median age was 64 years (range 21-86). Disease stage ranged form IIC to IV, with 57% IIIC. Most patients (n=53) received two cycles prior to resection (range 1-7 cycles). Dual ICI was the most common approach (n=62). Pathologic complete response was seen in 20 patients (25%), near-pCR in 2 (2%), partial PR in 8 (10%), while 41 (50%) were non-responders an 10 (12%) had a discrepant PR between two or more resected sites. Immune-related adverse events were observed in 34 patients (42%); 21 (26%) grade 1-2 and 13 (16%) grade 3-4. The authors conclude that neoadjuvant ICI therapy in the real world is associated with a less favorable PR and similar toxicity compared to what is reported in clinical trials.