Real-World Use of Adjuvant Nivolumab for Resected Stage III-IV Melanoma: 2-Year Analysis of AdjuMel.

INTRODUCTION: Following the positive findings of the phase 3 CheckMate 238 trial, adjuvant nivolumab has become a standard therapy in patients with completely resected stage III-IV melanoma. The prospective, ongoing AdjuMel study is evaluating the real-world use, effectiveness, and safety of adjuvant nivolumab in patients with resected melanoma in France. Here we report 2-year results from the third interim analysis of AdjuMel. METHODS: This observational, prospective study is evaluating data from patients with resected stage III-IV melanoma treated with adjuvant nivolumab in France. Study outcomes include effectiveness, safety, and treatment patterns of anti-programmed cell death-1 (PD-1, nivolumab) under routine clinical practice in the adjuvant setting. The primary endpoint was relapse-free survival (RFS). This third interim analysis (data cut-off: 3 November 2023) included patients with ≥ 1 follow-up visit, using data collected up to the 24-month visit. RESULTS: Overall, 343 patients (median [range] age 65 [27-95] years; 57.7% male; 41.7% BRAF-mutation positive) were evaluable in this interim analysis, with a median (range) follow-up of 23.4 (2.1-27.3) months. At treatment initiation, 86.8% and 13.2% of patients had stage III and IV disease, respectively. The 2-year RFS rate was 52.8% (95% confidence interval 47.0-58.2). The risk of recurrence or death was lower in patients with stage IIIA disease versus IIIB-D (hazard ratio [HR] 0.43) and in those aged < 75 versus ≥ 75 years (HR 0.56), and higher in patients with versus without tumor ulceration (HR 1.99). The safety profile of adjuvant nivolumab was consistent with that reported in CheckMate 238, and patient quality of life did not appear to be adversely affected. CONCLUSIONS: These real-world data are in line with those reported in randomized clinical trials, despite the broader inclusion criteria of the study population. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04550247.