FDA Approves Ipilimumab in Adjuvant Treatment of Stage III Melanoma

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On October 28, 2015, the U.S. Food and Drug Administration (FDA) approved the monoclonal antibody ipilimumab (Yervoy) for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. The CTLA-4 antibody–blocking drug, ipilimumab, was approved previously for treatment of unresectable or metastatic melanoma.

The recent approval was based on improvement in recurrence-free survival in a randomized, double-blind, placebo-controlled trial in 951 patients with resected stage IIIA (lymph node > 1 mm), IIIB, and IIIC (with no in-transit metastases) histologically confirmed cutaneous melanoma.1  

The primary efficacy endpoint was recurrence-free survival. The median recurrence-free survival was 26 and 17 months in the ipilimumab (n = 475) and placebo (n = 476) arms, respectively (hazard ratio [HR] = 0.75, 95% confidence interval [CI] = 0.64–0.90, P < .002). 

Safety data were evaluated in 945 patients (median age = 51 years, 62% male), who received ipilimumab at 10 mg/kg (n = 471) or placebo (n = 474) given as an intravenous infusion for four doses every 3 weeks, followed by 10 mg/ kg every 12 weeks beginning at week 24, up to a maximum of 3 years. Ipilimumab-treated patients received a median of four doses, and 36% of patients received ipilimumab for longer than 6 months. Ipilimumab was discontinued for adverse reactions in 52% of patients.   ■


1. Eggermont AM, et al: Lancet Oncol 16:522-530, 2015.





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