Successful Phase III trial (CA184-029 (EORTC 18071) five year analysis of Yervoy (ipilimumab) for stage III melanoma.- BMS

Bristol-Myers Squibb Company announced superior efficacy with Yervoy 10 mg/kg versus placebo on all survival endpoints in the Phase III trial CA184-029 (EORTC 18071) evaluating stage III melanoma patients who are at high risk of recurrence following complete surgical resection.

In the study, Yervoy compared with placebo significantly improved overall survival (OS) (HR=0.72 [95.1% CI: 0.58-0.88; p=0.001]), a secondary endpoint, with five-year OS rates at 65.4% in the Yervoy group and 54.4% in the placebo group. Distant metastasis-free survival (DMFS), a secondary endpoint, was also significantly improved versus placebo (HR=0.76 [95.8% CI: 0.64-0.92; p=0.002]) and had five-year DMFS rates of 48.3% and 38.9% 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 (HR=0.76 [95% CI: 0.64-0.89; p<0.001). 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%), hepatic (10.8%), and endocrine (7.9%). 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.

See-"Prolonged Survival in Stage III Melanoma with Ipilimumab Adjuvant Therapy"- Alexander M.M. Eggermont, M.D., Ph.D., Vanna Chiarion-Sileni, M.D., Jean-Jacques Grob, M.D., Ph.D., Reinhard Dummer, M.D., et al., October 8, 2016DOI: 10.1056/NEJMoa1611299.

Comment:On the basis of data from a phase II trial that compared the checkpoint inhibitor ipilimumab at doses of 0.3 mg, 3 mg, and 10 mg per kilogram of body weight in patients with advanced melanoma, this phase III trial evaluated ipilimumab at a dose of 10 mg per kilogram in patients who had undergone complete resection of stage III melanoma.