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Yervoy (Ipilimumab) Meets Primary Endpoint in Phase III Melanoma Trial

Recurrence-free survival shows significant improvement

Positive results have been reported from a phase III study of Yervoy (ipilimumab, Bristol-Myers Squibb) in patients with stage 3 melanoma who were at high risk of recurrence following complete surgical resection — an adjuvant setting.

The new data will be presented at the 50th annual meeting of the American Society of Clinical Oncology (ASCO), being held May 30–June 3 in Chicago, Illinois.

The randomized, double-blind CA184-029 trial enrolled patients in the U.S., Canada, Europe, Russia, and Australia who underwent complete resection of stage 3 cutaneous melanoma, excluding lymph node metastasis ≤ 1 mm or in-transit metastasis. Patients had stage 3A (21%), 3B (45%), or 3C (35%) melanoma; 41% percent had ulcerated primary melanoma, and 56% had macroscopic lymph-node involvement. The patients were stratified by stage and region and were randomly assigned to receive ipilimumab 10 mg/kg (n = 475) or placebo (n = 476) every 3 weeks for four doses, and then every 3 months for up to 3 years until completion, disease recurrence, or unacceptable toxicity. The study’s primary endpoint was recurrence-free survival (RFS).

Ipilimumab 10 mg/kg significantly improved RFS compared with placebo, for a 25% reduction in the risk of recurrence or death (hazard ratio, 0.75; P = 0.0013). At 3 years, an estimated 46.5% of patients treated with ipilimumab were free of disease recurrence compared with an estimated 34.8% of patients given placebo. The median RFS was 26.1 months for ipilimumab and 17.1 months for placebo, with a median follow-up of 2.7 years.

Treatment-related adverse events (AEs) were common, with most being immune-related. Grade-3 or greater AEs in the ipilimumab and placebo arms, respectively, were gastrointestinal (15.9% vs. 0.8%), liver (10.6% vs. 0.2%), endocrine (8.5% vs. 0%), and dermatologic (4.5% vs. 0%). Most AEs were managed and resolved using established algorithms. According to investigator assessments, the incidence of drug-related death in the ipilimumab arm was 1.1% (n = 5) compared with no drug-related deaths in the placebo arm. Of the patients who began treatment with ipilimumab, 48.8% (230/471) discontinued treatment because of drug-related AEs compared with 1.7% (n = 8) of the placebo arm.

Source: Bristol-Myers Squibb; June 2, 2014.

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