Bristol-Myers Squibb melanoma drug Yervoy may extend patients' lives up to 10 years
PRINCETON, N.J.—Bristol-Myers Squibb Co. has announced results from a pooled analysis of survival data for 12 studies— consisting of 1,861 subjects total—in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy (ipilimumab) at different doses and regimens. Central to these announced results, the data for which will be presented at the 2013 European Cancer Congress Sept. 28, is that a plateau in the survival curve begins at approximately three years, with follow-up of up to 10 years in some patients.
"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 of 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 percent of treatment-naïve and 20 percent of previously treated patients were alive at three years after being treated with an ipilimumab regimen," added Dr. F. Stephen Hodi, of the Department of Medicine of Harvard Medical School and 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."
Safety data were not included in this analysis; however, safety data from the individual studies have been reported. Overall, the types of adverse events attributed to Yervoy are generally mechanism-related (i.e. 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.
Yervoy, 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. Yervoy 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 Yervoy's effect in patients with melanoma is indirect, possibly through 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 patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries.
SOURCE: Bristol-Myers Squibb news release