Phase 3 Study Evaluating Yervoy® (Ipilimumab) for Melanoma in an Adjuvant Setting Meets Primary Endpoint of Recurrence-Free Survival

• Results demonstrate a significant improvement in recurrence-free survival for an investigational dose of Yervoy vs. placebo for patients with stage 3 melanoma at high risk of recurrence following surgical resection
• Types of adverse events were generally consistent with those observed using Yervoy in advanced melanoma, although a higher incidence of endocrinopathies was observed

Third positive Phase 3 trial of Yervoy in melanoma, now with a study demonstrating efficacy in an earlier stage of the disease
Bristol-Myers Squibb Company BMY today announced results from a Phase 3 randomized, double blind study demonstrating that Yervoy (ipilimumab) 10 mg/kg (n=475) significantly improved recurrence-free survival (RFS, the length of time before recurrence or death) vs. placebo (n=476) for patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection, an adjuvant setting. A twenty-five percent reduction in the risk of recurrence or death was observed (HR = 0.75; 95% CI = 0.64–0.90; p = 0.0013). At three years, an estimated 46.5% of patients treated with Yervoy were free of disease recurrence compared to an estimated 34.8% of patients on placebo. The median RFS was 26.1 months for Yervoy vs. 17.1 months for placebo, with a median follow-up of 2.7 years. The data will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology at 3:00 p.m. CDT today and highlighted at a Congress press briefing (LBA9008).

Treatment-related adverse events were common, with most being immune-related, and were managed using standard Yervoy adverse event (AE) management protocols. These Grade ≥3 AEs in the Yervoy 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 were managed and resolved using established algorithms. Per investigator assessment, the incidence of drug-related death in the Yervoy arm was 1.1% (n=5) and no drug-related deaths were observed in the placebo arm. Of the patients who began treatment with Yervoy (n=471), 48.8% (n=230) discontinued treatment due to drug-related AEs vs. 1.7% (n=8) in the placebo arm.

“Despite the strong likelihood of disease recurrence among stage 3 melanoma patients, there are very limited treatment options available to help reduce the risk of metastatic disease after surgery. There is only one class of therapies available to patients and this standard of care has remained largely unchanged over the last 20 years,” said Alexander Eggermont, director general, Gustave Roussy Cancer Campus Grand Paris, Villejuif, France, presenter of the results and lead author of the abstract. “These findings are significant not only because ipilimumab is the first immune-checkpoint inhibitor to demonstrate an improvement in recurrence-free survival in this earlier treatment setting, but also because this benefit was observed across all patient sub-groups, including those who were at highest risk of recurrence. These findings add to the growing body of data for ipilimumab, which is currently approved at 3 mg/kg for metastatic melanoma.”

“This is the third positive Phase 3 trial of Yervoy in melanoma, reflecting our commitment to seeking options to address unmet medical needs across stages of disease and lines of therapy for melanoma,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunosciences, Bristol-Myers Squibb. “These findings demonstrate, for the first time, that Yervoy has the potential to reduce the risk of cancer recurrence at an earlier stage of melanoma and support our belief that immuno-oncology may have broad applicability across lines of therapy and stages of the disease.”

Additional trials of Yervoy for melanoma in the adjuvant setting are ongoing, including a Phase 3 study sponsored by the U.S. National Cancer Institute and conducted by ECOG-ACRIN investigating Yervoy at doses of 3 mg/kg and 10 mg/kg, or high-dose interferon alfa-2b in patients with high-risk stage 3 and resectable stage 4 melanoma.