Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analysis of Yervoy™ (Ipilimumab) Treatment in More Than 1,800 Patients with Metastatic or Locally Advanced or Unresectable Melanoma PR Newswire PRINCETON, New Jersey, September 27, 2013 PRINCETON, New Jersey, September 27, 2013 /PRNewswire/ -- *In this pooled analysis of 12 studies, a plateau in the survival curve begins at approximately three years, with some patients followed for up to ten years *Three-year estimated survival rate of 22% observed in patients treated with ipilimumab *Findings are based on different doses and regimens and show consistency of long-term survival data for ipilimumab in metastatic melanoma *Data presented as a late-breaker at the 2013 European Cancer Congress and highlighted at Congress press briefing Bristol-Myers Squibb Company (NYSE: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 ipilimumab are generally mechanism (immune)-based.Ipilimumab 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 ipilimumab 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 ipilimumab," 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 ipilimumab 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 OS 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 ipilimumab at different doses and regimens. The majority of patients received ipilimumab 3 mg/kg (n=965) or at 10 mg/kg (n=706). Ipilimumab was given every 3 weeks for 4 doses, and most studies included the option to receive either ipilimumab retreatment or ipilimumab maintenance therapy for eligible patients. About ipilimumab Ipilimumab, which is a recombinant, human monoclonal antibody, blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab's effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses. On March 25, 2011, the FDA approved ipilimumab 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. In July 2011, the EU approved ipilimumab 3 mg/kg for the treatment of adult patients with previously-treated unresectable or metastatic melanoma. Yervoy™ (ipilimumab) is now approved in more than 40 countries. For full Prescribing Information, please refer to the SMPC. ^[ ^1 ^] YERVOY is a registered trademark of Bristol-Myers Squibb Company. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2012, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Reference 1.Yervoy Summary of Product Characteristics. July 2011. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002213/human_med_001465.jsp∣=WC0b01ac058001d124 Last accessed September 2013. 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Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analysis of Yervoy™ (Ipilimumab) Treatment in More Than
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