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Efficacy and safety of nivolumab in metastatic melanoma: real-world practice

Anti-PD1 antibodies have revolutionized the management of patients with advanced melanoma. In clinical trials, the efficacy of nivolumab is being tested in selected populations of patients. The aim of this study was to analyse the efficacy and safety of nivolumab in patients with advanced melanoma under real-life conditions. A retrospective, observational study was conducted in patients treated with nivolumab for advanced melanoma included in the RIC-Mel network. Overall survival and progression-free survival (PFS) were assessed using the Kaplan-Meier method. Eighty-seven patients were included with a median follow-up of 31 months. The median PFS was 13 months (95% CI: 7–28). Objective response rate was 33.3%. Among patients achieving a complete response, the response was maintained after treatment discontinuation in 80.7% of patients for a median duration of 21.7 months. Multivariate analysis showed that an increased lactate dehydrogenase level (p = 0.03; HR: 1.21; 95% CI: 1.02–1.45) and brain metastases (p = 0.024; HR: 2.78; 95% CI: 1.14–6.77) were correlated with a decrease in PFS. Grade 3 or 4 adverse events were found in 10.3% of patients. Based on our study, the efficacy and safety of nivolumab in patients with advanced melanoma are consistent with previously published data.