Real-World Use of Adjuvant Nivolumab for Resected Stage III–IV Melanoma: 2-Year Analysis of AdjuMel
Abstract
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.
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BibTeX
@article{dalle2026realworld,
title = {{Real-World Use of Adjuvant Nivolumab for Resected Stage III–IV Melanoma: 2-Year Analysis of AdjuMel}},
author = {Stéphane Dalle and Philippe Saiag and Céleste Lebbé and Jean-Jacques Grob and Brigitte Dréno and Sophie Dalac and Bernard Asselain and François Skowron and Sophie Darras and Nicolas Jovenin and Gaëlle Quereux and Amir Khammari and Capucine Rieuf and Florence Brellier and Laurent Mortier},
journal = {Dermatology and Therapy},
year = {2026},
month = aug,
doi = {10.1007/s13555-026-01853-4},
url = {https://inserm.hal.science/inserm-05732045v1},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Real-World Use of Adjuvant Nivolumab for Resected Stage III–IV Melanoma: 2-Year Analysis of AdjuMel
AU - Stéphane Dalle
AU - Philippe Saiag
AU - Céleste Lebbé
AU - Jean-Jacques Grob
AU - Brigitte Dréno
AU - Sophie Dalac
AU - Bernard Asselain
AU - François Skowron
AU - Sophie Darras
AU - Nicolas Jovenin
AU - Gaëlle Quereux
AU - Amir Khammari
AU - Capucine Rieuf
AU - Florence Brellier
AU - Laurent Mortier
PY - 2026
DA - 2026/08/29
JO - Dermatology and Therapy
DO - 10.1007/s13555-026-01853-4
UR - https://inserm.hal.science/inserm-05732045v1
AB - 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.
SN - 2193-8210
SN - 2193-8210
ER -