Phase 3 Study: Yervoy Improves Overall Survival in Fully Resected Stage III Melanoma Patients

Yervoy 10 mg/kg demonstrated superiority versus placebo on all survival endpoints in the Phase 3 trial CA184-029 (EORTC 18071) evaluating stage III melanoma patients who are at high risk of recurrence following complete surgical resection, according to Bristol-Myers Squibb Company. In the study, Yervoy compared with placebo significantly improved overall survival (OS), a secondary endpoint, with five-year OS rates at 65.4 percent in the Yervoy group and 54.4 percent in the placebo group. Distant metastasis-free survival (DMFS), a secondary endpoint, was also significantly improved versus placebo and had five-year DMFS rates of 48.3 percent and 38.9 percent in the Yervoy and placebo groups, respectively. In this updated five-year analysis, the recurrence-free survival (primary endpoint) benefit observed previously with Yervoy was maintained. The safety profile remained consistent with the initial analysis, with no new deaths or safety signals. The most common grade 3/4 immune-related adverse events in the Yervoy group were gastrointestinal (16.1 percent), hepatic (10.8 percent), and endocrine (7.9 percent).

These data were featured during the 2016 European Society for Medical Oncology Congress Press Program and simultaneously published in The New England Journal of Medicine.

“Despite surgical intervention, most patients with stage III melanoma experience disease recurrence and progress to metastatic disease, reinforcing the unmet need for effective systemic therapies in the adjuvant setting,” said Alexander M.M. Eggermont, MD, PhD, director general, Cancer Institute Gustave Roussy in Villejuif, France. “The impact of Yervoy on overall survival, distant-metastasis free survival, and recurrence-free survival observed in study -029 offers physicians new insights in the treatment of adjuvant melanoma.”

In stage III melanoma, the disease has not yet spread to distant lymph nodes or to other parts of the body and requires surgical resection of the primary tumor as well as the involved lymph nodes. The stage III patient population is heterogeneous with disease-specific survival rates of 78%, 59%, and 40% for stage IIIA, IIIB, and IIIC melanoma, respectively.

“The results from study -029 are important data for the scientific community and underscore our ongoing dedication to improving survival across stages of melanoma,” said Vicki Goodman, MD, development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “Yervoy is the first immune checkpoint inhibitor to demonstrate a statistically significant survival benefit for high-risk patients with fully resected stage III melanoma. With further evaluation of our Immuno-Oncology agents and different dosing options, we remain committed to further research across the full continuum of melanoma treatment.”