Jeffrey A. Sosman, MD reviewing Eggermont AMM et al. N Engl J Med 2016 Oct 8.

Recurrence-free survival was improved with ipilimumab versus placebo, but at a cost of significant toxicity.

Ipilimumab was recently shown in a randomized, controlled, phase III trial (EORTC 18071) to significantly improve recurrence-free survival (RFS) in patients with resected, high-risk, stage III melanoma at a median follow-up of 2.7 years (Lancet Oncol 2015; 16:522). Until that time, adjuvant interferon alfa, a standard of care, had demonstrated only a minimal improvement in overall survival (OS).

Now, investigators have updated results for 951 patients in the EORTC 18071 trial who received ipilimumab (10 mg/kg) or placebo intravenously once every 3 weeks for 12 weeks, and then once every 3 months for up to 3 years or until recurrence or unacceptable toxicity.

At a median 5.3 years of follow-up, 5-year RFS (the primary endpoint) was improved with ipilimumab versus placebo (40.8% vs. 30.3%; hazard ratio, 0.76; P<0.001), as were 5-year distant metastatic-free survival (48.3% vs. 38.9%; HR, 0.76; P=0.002), and OS (65.4% vs. 54.4%; HR, 0.72; P=0.001). Grade 3 or 4 adverse events occurred in more ipilimumab recipients (54.1% vs. 26.2%), as did immune-related grade 3 or 4 events (41.6% vs. 2.7%); 1.1% of ipilimumab recipients died from immune-related events.

CITATION(S):

Eggermont AMM et al. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. N Engl J Med 2016 Oct 8; [e-pub].

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