Positive new overall survival data for Opdivo/Yervoy combo

Pharma major Bristol-Myers-Squibb (NYSE: BMY) has, for the first time, presented overall survival data from CheckMate -069, showing the positive effects of combination treatment with its Opdivo (nivolumab) and Yervoy (ipilimumab), at the American Association for Cancer Research (AACR) 2016.

This is a Phase II trial and the first randomized study to evaluate the Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma. In the trial, the Opdivo and Yervoy combination regimen demonstrated a two-year overall survival (OS) rate of 69% compared to 53% for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma. Overall survival was an exploratory endpoint in this trial. The safety profile of the Opdivo and Yervoy combination regimen in this study was consistent with previously reported studies.

The US Food and Drug Administration granted accelerated approval to the combination of Opdivo and Yervoy as a treatment for patients with BRAF V600 wild-type unresectable or metastatic melanoma, based on findings from the CheckMate-069 study last November. In January, the combo was also cleared for the treatment of unresectable or metastatic melanoma. In the USA, the combination drug costs $141,000 for a four-dose course of treatment, or $256,000 for a year's worth of therapy, according to the company. The two drugs, purchased individually, carry a list price of almost $300,000.

Also presented Phase I five-year data