Neoadjuvant immunotherapy for patients with resectable melanoma

Abstract Introduction Randomized clinical trials have shown that neoadjuvant immunotherapy leads to superior event-free survival (EFS) compared to adjuvant treatment in patients with resectable stage III/IV cutaneous melanoma. Although these results are encouraging, data from unselected real-world populations remain limited. Sweden was among the first countries to adopt neoadjuvant immunotherapy into standard practice, providing a unique opportunity to assess its impact outside of controlled trial settings. Method This retrospective, population-based study included patients from three academic medical centers across Sweden. All individuals with advanced, yet resectable, cutaneous melanoma who received neoadjuvant immune checkpoint inhibitors (ICIs) between January 1, 2022, and June 30, 2024, were eligible for inclusion. Result A total of 118 patients were analyzed. The median number of neoadjuvant ICI treatments was two, with 98% receiving nivolumab monotherapy. Surgery was carried out as planned in 88% of the patients. Among all patients who initiated treatment, 42% achieved major pathological response (MPR), 9% had partial pathological response (pPR), and 31% showed no pathological response (pNR). At a median follow-up of 12 months, the estimated 12-month EFS was 72% (95% CI, 63–82), and recurrence-free survival (RFS) was 74% (95% CI, 65–83). Stratified by response, the 12-month RFS was 94% in patients with MPR, 91% in those with pPR, and 61% in those with pNR. Severe (grade ≥3) immune-related adverse events were observed in 9% of patients. Discussion These real-world, population-based findings mirror those from clinical trials, reinforcing the effectiveness and tolerability of neoadjuvant immunotherapy for resectable stage III/IV melanoma.