Under the agreement, the two companies will conduct a Phase I/II study to evaluate the safety and efficacy of the combination. If appropriate, the companies may conduct further development of the combination. This agreement represents an important cross-company collaboration exploring the potential role of this regimen in the treatment of metastatic melanoma.
"Metastatic melanoma is one of the most aggressive forms of cancer," said Brian Daniels, senior vice president, Development and Medical Affairs, Bristol-Myers Squibb. "We are excited to be working with Roche to evaluate the potential that together YERVOY and vemurafenib could improve outcomes for melanoma patients."
The U.S. Food and Drug Administration (FDA) approved YERVOY 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma on March 25, 2011 YERVOY is the first and only therapy approved for unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival based on results from a pivotal randomized, double-blind Phase III study (020) that included 676 patients with unresectable or metastatic melanoma who were previously treated with one or more of the following: aldesleukin, dacarbazine, temozolomide, fotemustine, or carboplatin. YERVOY is a recombinant, human monoclonal antibody that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4), 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.
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.