Bristol-Myers Squibb Reports First Randomized Study Evaluating Opdivo+Yervoy Regimen Shows Superior Efficacy Related to Yervoy Alone

Bristol-Myers Squibb Company

today announced positive results from a Phase II trial (CheckMate -069), evaluating the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen versus Yervoy alone in patients with previously untreated advanced melanoma. Patients with BRAF wild-type mutation status treated with the Opdivo+Yervoy regimen experienced a higher objective response rate (ORR) of 61% (n=44/72) – the primary study endpoint – compared to 11% (n=4/37) for patients administered Yervoy monotherapy (P<0.001). Complete responses were also reported in 22% (n=16) of patients with BRAF wild-type mutation status administered the Opdivo+Yervoy regimen and in no patients who received Yervoy monotherapy. Similar results were also observed in BRAF mutation-positive patients. The safety profile was consistent with previously-reported studies evaluating the Opdivo+Yervoy regimen and included grade 3-4 colitis (17%), diarrhea (11%), and increased alanine aminotransferase (11%). These data will be presented today at the American Association for Cancer Research (AACR) Annual Meeting and featured during a press briefing at 8:30 AM EDT [Abstract #2860]. The results will also be published in The New England Journal of Medicine (NEJM). "These data are unprecedented in advanced melanoma, showing efficacy results that have not previously been observed with Immuno-Oncology agents," said F. Stephen Hodi, M.D., Associate Professor of Medicine, Dana-Farber Cancer Institute and an author of the NEJM manuscript. "With the Opdivo+Yervoy regimen, we observed much higher response rates which were sustained, as well as significant reduction in tumor burden than with Yervoy. These responses seen in CheckMate -069 demonstrate the potential of this regimen in patients with metastatic melanoma." Melanoma is the most serious form of skin cancer and strikes adults of all ages. While melanoma represents less than 5% of skin cancers, it results in most deaths. The CheckMate -069 trial is the first randomized study reporting outcomes in the first-line setting for advanced melanoma patients treated with a regimen of immune checkpoint inhibitors compared to Yervoy. The efficacy and safety results of CheckMate -069 are consistent with the Phase Ib dose-ranging trial (CheckMate -004), which evaluated the safety and activity of the regimen in patients with advanced melanoma. "The CheckMate -069 results reinforce our belief that the future lies in the combination of Immuno-Oncology agents, including Opdivo and Yervoy, that can leverage the immune system in order to offer cancer patients options with greater efficacy beyond current treatment approaches," said Michael Giordano, senior vice president, Head of Development, Oncology. "Our strategy has always been to build upon the success achieved with Yervoy. In 2011, long-term survival for metastatic melanoma patients was unheard of, but the introduction of Yervoy has helped to make this a reality for some patients. Now we are building on this success with Opdivo, which was the first PD-1 inhibitor to demonstrate an improved survival benefit."