Treatment-related select adverse events of any grade were associated with higher overall response rate, but no progression-free survival benefit, among patients with advanced melanoma treated with nivolumab monotherapy, according to a study published in the Journal of Clinical Oncology.1

To evaluate the safety profile of single-agent nivolumab in patients with metastatic or unresectable melanoma, and to examine the management of adverse events, researchers conducted a pooled safety analysis of data from 4 studies, including 2 phase 3 trials.

Investigators assessed  the rate of treatment-related adverse events, time to onset, and resolution of potentially immune-mediated adverse events, and impact of those adverse events and immunosuppressive agents on antitumor efficacy, in 576 patients who received nivolumab 3 mg/kg intravenously once every 2 weeks.

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The study showed that 71% (95% CI, 67-75) of patients experienced any-grade treatment-related adverse events, and 10% (95% CI, 8-13) reported grade 3 to 4 treatment-related adverse events. The most common adverse events were fatigue, pruritus, diarrhea, and rash.

Nearly half (49%) of patients experienced potentially immune-mediated adverse events, which were most frequently skin related, gastrointestinal, endocrine, and hepatic, and 4% had grade 3 to 4 select adverse events.

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About 24% of patients received systemic immunosuppressive therapy to manage immune-mediated adverse events, which resolved in most cases. After adjusting for the number of doses, the study demonstrated that objective response rate was significantly higher in patients who experienced any grade immune-mediated adverse events compared with those who did not.

Occurrence of these adverse events was not, however, associated with a progression-free survival benefit.


  1. Weber JS, Hodi FS, Wolchok JD, et al. Safety profile of nivolumab monotherapy: A pooled analysis of patients with advanced melanoma. J Clin Oncol. 2016 Nov 14. doi: 10.1200/JCO.2015.66.1389. [Epub ahead of print]