Bristol-Myers Says Expecting Three-Year Survival Rate of 22% for Yervoy Study

Bristol-Myers Squibb Company BMY today announced results from a pooled analysis of survival data for 12 studies (n=1,861) in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy^® (ipilimumab) at different doses and regimens. A plateau in the survival curve begins at approximately three years, with follow-up of up to ten years in some patients. Approximately 22% of patients were alive at three years. The data will be presented at the 2013 European Cancer Congress on September 28 at 1:00 p.m. CEST and were highlighted at a Congress press briefing (Abstract # 24LBA, “Pooled analysis of long-term survival data from Phase 2 and Phase 3 trials of ipilimumab in metastatic or locally advanced, unresectable melanoma”). Safety data were not included in this analysis. However, safety data from these individual studies have been reported. 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. In these clinical trials, adverse events associated with Yervoy were managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants. “This pooled analysis reinforces the long-term survival data seen in the individual studies and provides additional insight into the overall survival of metastatic melanoma patients treated with Yervoy,” said Brian Daniels, senior vice president, Global Development and Medical Affairs. “The durability and consistency of long-term survival observed in this analysis is encouraging as we continue to advance the research and development of our immuno-oncology portfolio.” “In this analysis, approximately 26% of treatment-naïve and 20% of previously-treated patients were alive at three years after being treated with an ipilimumab regimen,” said F. Stephen Hodi, M.D., Department of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. “This pooled analysis is encouraging, particularly when considering that metastatic melanoma is one of the most aggressive forms of cancer and historically, average survival was just six to nine months.” About The Analysis This pooled analysis was conducted to provide a more precise estimate of the long-term survival effect of Yervoy in patients with metastatic melanoma. It is comprised of patient-level data from 12 prospective and retrospective studies, including two Phase 3 trials (n=790), eight Phase 2 trials (n=821), and two retrospective, observational studies (n=250), which have been or will be reported on as individual studies. Three studies included overall survival follow-up in some patients for up to ten years. The analysis included both previously-treated (n=1,257) and previously untreated patients (n=604) who received Yervoy at different doses and regimens. The majority of patients received Yervoy 3 mg/kg (n=965) or 10 mg/kg (n=706). Yervoy was given every 3 weeks for 4 doses, and most studies included the option to receive either Yervoy retreatment or Yervoy maintenance therapy for eligible patients.