Adjuvant ipilimumab significantly improved recurrence-free survival for patients with completely resected high-risk stage 3 melanoma, a study published in the journal The Lancet Oncology has shown.1
Researchers sought to evaluate ipilimumab in the adjuvant setting for patients with completely resected stage 3 melanoma at high risk of recurrence.
For the international, double-blind, phase III trial, researchers enrolled 951 patients and randomly assigned them 1:1 to ipilimumab 10 mg/kg IV or placebo every 3 weeks for four doses, then every 3 months for up to 3 years.1
Results showed that at a median follow-up of 2.74 years, there were 234 recurrence-free survival events in the ipilimumab group versus 294 in the placebo group.
Researchers found a median recurrence-free survival of 26.1 months (95% CI: 19.3-39.3) and 17.1 months (95% CI: 13.4-21.6) in the ipilimumab and placebo groups, respectively.
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In addition, the study showed that the 3-year recurrence-free survival was 46.5% (95% CI: 41.5-51.3) in the ipilimumab group compared with 34.8% (95% CI: 30.1-39.5) in the placebo group.1
In regard to safety, the most common grade 3 to 4 adverse events associated with ipilimumab use were diarrhea (10%), colitis (~8%), increased alanine transaminase (5%), increased aspartate transaminase (~5%), and hypophysitis (~6%).
The most common immune-mediated adverse reactions included diarrhea (10%), colitis (~8%), elevated liver function enzymes (5%), hypophysitis (~6%), and dermatological side effects (4%).1