Bristol-Myers Squibb's second YERVOY Phase 3 trial on metastatic melanoma meets primary endpoint

Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a second Phase 3 randomized, double blind study demonstrating that YERVOY™ (ipilimumab) prolonged the lives of patients with metastatic melanoma. The data were published today in the New England Journal of Medicine and presented at the 47^th Annual Meeting of the American Society of Clinical Oncology. (Abstract #5)

In study 024, patients had not received prior treatment for metastatic melanoma and were randomized to receive the investigational dose of YERVOY 10mg/kg in combination with the chemotherapy dacarbazine (850 mg/m²) or dacarbazine alone. There was a significant improvement in overall survival (HR = 0.72)

Overall, the types of adverse events (AEs) attributed to YERVOY in study 024 were generally mechanism (immune)- based and consistent with prior YERVOY studies. A higher-than-expected rate of liver enzyme elevations was reported. There were no gastrointestinal perforations in either arm of the study and no drug-related deaths in the YERVOY arm. Adverse events associated with YERVOY were managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.

"We now have Phase 3 data demonstrating that ipilimumab improved survival in patients with metastatic melanoma in both the first and second-line settings," said Jedd Wolchok, M.D., Ph.D., Memorial Sloan-Kettering Cancer Center, and presenter of the study results. "For physicians who treat cancer, improving overall survival is what we strive for with our patients and I believe ipilimumab is a foundational therapy for metastatic melanoma."

"In this study, the one, two and three-year estimated survival rates demonstrate prolonged survival for patients in the YERVOY plus dacarbazine arm," said Caroline Robert, M.D., Institute Gustave Roussy in Paris, France, and lead author on the New England Journal of Medicine paper. "Results from this study are significant in a disease as devastating at metastatic melanoma."

The combination of dacarbazine with YERVOY is not an FDA approved-regimen. In addition, study 024 was not designed to compare the safety and efficacy of the FDA- approved monotherapy dose of 3 mg/kg for unresectable or metastatic melanoma vs. the investigational dose of 10 mg/kg. Bristol-Myers Squibb plans to conduct a head-to-head Phase 3 study comparing the safety and efficacy of these two doses given as a monotherapy in patients with unresectable or metastatic melanoma.