Bristol-Myers Squibb, Roche collaboration to combine metastatic melanoma treatments
NEW YORK—Bristol-Myers Squibb Company and Roche have entered into a clinical collaboration agreement for the evaluation of the utility of Bristol-Myers Squibb's CTLA-4 inhibitor, YERVOY (ipilimumab), when combined with Roche's investigation oral BRAF inhibitor, vemurafenib, in the treatment of patients suffering from a specific type of metastatic melanoma.
"Metastatic melanoma is one of the most aggressive forms of cancer," said Brian Daniels, senior vice president of Development and Medical Affairs at Bristol-Myers Squibb, in a statement about the collaboration. "We are excited to be working with Roche to evaluate the potential that together YERVOY and vemurafenib could improve outcomes for melanoma patients."
Under the terms of the agreement, Bristol-Myers Squibb and Roche will conduct a Phase I/II study to determine the safety and efficacy of the two medicines in combination, and if required, they will also conduct additional development of the combination. The collaboration is a prime opportunity to evaluate the potential of a new regimen for treating metastatic melanoma.
Bristol-Myers Squibb's YERVOY 3 mg/kg received U.S. Food and Drug Administration (FDA) approval earlier this year, on March 25, and is the fisrt and only therapy with approval for the treatment of unresectable or metastatic melanoma that demontratse a marked improvement in overall survival.
The drug is a recombinant, human monoclonal antibody that works by blocking the cytotoxic T-lymphocyte antigen-4 (CTLA-4), which is a negative regulator of T-cell activation. YERVOY binds to CTLA-4 and blocks the interaction of the antigen with its ligands, a blocking that has proven to boost T-cell activation and proliferation.
Due to its effects in terms of T-cell activation and proliferation, YERVOY can cause immune-mediated adverse reactions that range from severe to fatal, with the most common severe immune-mediated adverse reactions being hepatitis, dermatitis (including toxic epidermal necrolysis), enterocolitis, neuropathy and endocrinopathy. The most common adverse reactions to YERVOY were fatigue, diarrhea, pruritus, rash and colitis.
As for Roche's drug, vemurafenib is created to inhibit a mutated form of the BRAF protein that is found in almost half of all cases of melanoma.
"We have worked swiftly to advance the vemurafenib development program, knowing that patients with metastatic melanoma have a poor prognosis and limited treatment options," said Hal Barron M.D., Chief Medical Officer and Head of Global Product Development at Roche in a statement regarding the compound's New Drug Application. "The regulatory submissions of vemurafenib and the companion diagnostic to identify people with the type of melanoma specifically targeted by this medicine are exciting steps toward our goal of delivering a personalized therapy for this disease."
Metastatic melanoma is the deadliest form of skin cancer, and the National Cancer Institutes (NCI) predicted 68,130 new cases in the United States in 2010, and 8,700 deaths. It is aggressive, and prognosis is particularly poor if the cancer has spread. The NCI reports that if the melanoma is localized, the relative five-year survival rate is 98.1 percent. Once it has metastasized, the five- year survival rate plummets to 15.3 percent.
No financial details regarding the collaboration were released.