PRINCETON, N.J.—Bristol-Myers Squibb Co. has announcedresults from a pooled analysis of survival data for 12 studies—consisting of 1,861subjects total—in patients with metastatic or locally advanced or unresectablemelanoma who were treated with Yervoy (ipilimumab) at different doses andregimens. Central to these announced results, the data for which will bepresented at the 2013 European Cancer Congress Sept. 28, is that a plateau inthe survival curve begins at approximately three years, with follow-up of up to10 years in some patients.
"This pooled analysis reinforces the long-termsurvival data seen in the individual studies and provides additional insightinto the overall survival of metastatic melanoma patients treated with Yervoy,"said Brian Daniels, senior vice president of global development and medical affairs."The durability and consistency of long-term survival observed in this analysisis encouraging as we continue to advance the research and development of ourimmuno-oncology portfolio."
"In this analysis, approximately 26 percent oftreatment-naïve and 20 percent of previously treated patients were alive atthree years after being treated with an ipilimumab regimen," added Dr. F.Stephen Hodi, of the Department of Medicine of Harvard Medical School and Dana-FarberCancer Institute. "This pooled analysis is encouraging, particularly whenconsidering that metastatic melanoma is one of the most aggressive forms ofcancer and historically, average survival was just six to nine months."
Safety data were not included in this analysis; however,safety data from the individual studies have been reported. Overall, the typesof adverse events attributed to Yervoy are generally mechanism-related (i.e.immune-based). Yervoy can result in severe and fatal immune-related adversereactions due to T-cell activation and proliferation. In these clinical trials,adverse events associated with Yervoy were managed with protocol-specificguidelines, including the administration of systemic corticosteroids, doseinterruption/discontinuation and/or other immunosuppressants.
Yervoy, which is a recombinant, human monoclonalantibody, blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4).CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 andblocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade ofCTLA-4 has been shown to augment T-cell activation and proliferation. The mechanismof action of Yervoy's effect in patients with melanoma is indirect, possiblythrough T-cell mediated anti-tumor immune responses. On March 25, 2011, the U.S.Food and Drug Administration approved Yervoy 3 mg/kg monotherapy for patientswith unresectable or metastatic melanoma. Yervoy is now approved in more than40 countries.
SOURCE: Bristol-Myers Squibb news release
