Bristol-Myers Squibb Company (NYSE: BMY) today announced that YERVOY ® (ipilimumab), a novel immunotherapy and the first medicine approved for unresectable or metastatic melanoma in more than a decade, received the Prix Galien USA 2012 Award for Best Biotechnology Product. The award, which is selected by a preeminent scientific committee that includes several Nobel Laureates, recognizes the technical, scientific and clinical research skills and achievements necessary to develop innovative medicines and devices and is considered the most prestigious prize in biopharmaceutical research and development.
“Immuno-oncology, or the science of harnessing the immune system to fight cancer, represents a new paradigm in the treatment of cancer and this requires a willingness to think differently about the discovery, development and commercialization of these novel agents,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, Research & Development, Bristol-Myers Squibb. “YERVOY is an important representation of the progress we have made in this innovative field and a great example of how the combined contributions of BioPharma, biotech and academia can make a difference in people’s lives. We are proud that our work is being recognized by the Prix Galien USA Committee.”
The mechanism of action of YERVOY’s effect in patients with melanoma is indirect, possibly through T-cell-mediated anti-tumor immune responses. YERVOY is the only metastatic melanoma therapy proven in a Phase 3 study to deliver a durable long-term survival benefit at two years for 24% of previously-treated patients. In the study, median overall survival was 10 months (95% CI: 8.0-13.8) for YERVOY and 6 months (95% CI: 5.5-8.7) for the gp100 control arm.
Overall, the types of adverse events (AEs) attributed to YERVOY are generally mechanism (immune)- based. YERVOY can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation. Adverse events associated with YERVOY were managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.