Use of ipilimumab resulted in better rates of recurrence-free, overall, and distant metastasis–free survival compared with placebo in people with stage III melanoma in a randomized trial involving 951 individuals. Those who took the drug had more immune-related adverse events.
Patients had previously undergone complete resection, and were randomly assigned to receive ipilimumab 10 mg/kg (n=475) or placebo (n=476) every 3 weeks for 4 doses. They continued therapy every 3 months for up to 3 years. Among the results:
- The 5-year rate of recurrence-free survival was 41% in the ipilimumab group, vs 30% in the placebo cohort.
- Overall survival rates were 65% and 54%, respectively.
- Distant metastasis–free survival rates were 48% and 39%, respectively.
- Grade 3 or 4 adverse event rates were 54% and 26%, respectively.
- Grade 3 or 4 immune-related adverse event rates were 41% and 3%, respectively; 5 patients in the ipilimumab group died due to immune-related adverse events.
Eggermont A, Chiarion-Sileni V, Grob J, et al. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. [Published online ahead of print October 8, 2016]. N Engl J Med. doi:10.1056/NEJMoa1611299.
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Must Reads in Melanoma
FDA Approves First Treatment for Rare Skin Cancer, FDA news release; 2017 Mar 23
High-Dose Interferon vs Observation for Melanoma , J Clin Oncol; ePub 2017 Jan 30; Agarwala, et al
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