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PurposeIn the phase III CheckMate 238 study, adjuvant nivolumab (NIVO) significantly improved recurrence-free survival (RFS) and distant metastasis-free survival versus ipilimumab (IPI) in patients with resected stage IIIB-C or stage IV melanoma, with benefit sustained at 4 years. We report updated 5-year efficacy and biomarker findings.Patients and methodsPatients with resected stage IIIB-C/IV melanoma were stratified by stage and baseline PD-L1 expression and received NIVO 3 mg/kg every 2 weeks or IPI 10 mg/kg every 3 weeks for four doses and then every 12 weeks, both intravenously for 1 year until disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was RFS.ResultsAt a minimum follow-up of 62 months, RFS with NIVO remained superior to IPI (HR 0.72; 95% CI, 0.60-0.86; 5-year rates of 50% versus 39%). 5-year DMFS rates were 58% with NIVO versus 51% with IPI. Five-year OS rates were 76% with NIVO and 72% with IPI (75% data maturity: 228 of 302 planned events). Higher levels of TMB, tumor PD-L1, intratumoral CD8+ T cells and interferon-gamma-associated gene expression signature, and lower levels of peripheral serum C-reactive protein were associated with improved RFS and OS with both NIVO and IPI, albeit with limited clinically meaningful predictive value.ConclusionNIVO is a proven adjuvant treatment for resected melanoma at high-risk of recurrence, with sustained, long-term improvement in RFS and DMFS compared with IPI and high OS rates. Identification of additional biomarkers are needed to better predict treatment outcome.

Original publication




Journal article


Clinical cancer research : an official journal of the American Association for Cancer Research

Publication Date



Royal Marsden NHS Foundation Trust, London, United Kingdom.