Larkin J, et al. - CheckMate 037 has previously demonstrated that nivolumab resulted in more patients achieving an objective response compared with chemotherapy regimens in ipilimumab-refractory patients with advanced melanoma. In this current study, researchers report the coprimary overall survival (OS) end point of CheckMate 037. As per findings, nivolumab as compared with investigator’s choice chemotherapy (ICC) showed higher, more durable responses but no difference in survival. Caution was recommended while interpreting OS due to likelihood of its being influenced by an increased dropout rate before treatment, which resulted in crossover therapy in the ICC group, and by an increased proportion of patients in the nivolumab group with poor prognostic factors.

• Taking into account programmed death-ligand 1 expression, BRAFstatus, and best prior cytotoxic T-lymphocyte antigen-4 therapy response, patients were stratified.
• Thereafter, patients were randomly assigned 2:1 to nivolumab 3 mg/kg intravenously every 2 weeks or investigator’s choice chemotherapy (ICC; dacarbazine 1,000 mg/m² every 3 weeks or carboplatin area under the curve 6 plus paclitaxel 175 mg/m² every 3 weeks).
• Treatment was continued until patients experienced progression or unacceptable toxicity.
• A follow-up of approximately 2 years was also performed.

• A total of 272 patients were randomly assigned to nivolumab (99% treated) and 133 to ICC (77% treated).
• Brain metastases (20% v 14%) and increased lactate dehydrogenase levels (52% v 38%) at baseline were noted in more nivolumab-treated patients; anti–programmed death 1 agents were given to 41% of patients treated with ICC vs 11% of patients treated with nivolumab, after randomly assigned therapy.
• Data showed that median OS was 16 months for nivolumab vs 14 months for ICC (hazard ratio, 0.95; 95.54% CI, 0.73 to 1.24); median progression-free survival was 3.1 months vs 3.7 months, respectively (hazard ratio, 1.0; 95.1% CI, 0.78 to 1.436).
• In addition, for nivolumab vs ICC, notably higher overall response rate (27% v 10%) and median duration of response (32 months v 13 months) were noted.
• In patients on nivolumab (14% v 34%), fewer grade 3 and 4 treatment-related adverse events were observed.