NEW YORK—Bristol-Myers Squibb Company and Roche have enteredinto a clinical collaboration agreement for the evaluation of the utility ofBristol-Myers Squibb's CTLA-4 inhibitor, YERVOY (ipilimumab), when combinedwith Roche's investigation oral BRAF inhibitor, vemurafenib, in the treatmentof patients suffering from a specific type of metastatic melanoma.
"Metastatic melanoma is one of the most aggressive forms ofcancer," said Brian Daniels, senior vice president of Development and MedicalAffairs at Bristol-Myers Squibb, in a statement about the collaboration. "We are excited to be working with Roche toevaluate the potential that together YERVOY and vemurafenib could improveoutcomes for melanoma patients."
Under the terms of the agreement, Bristol-Myers Squibb andRoche will conduct a Phase I/II study to determine the safety and efficacy ofthe two medicines in combination, and if required, they will also conductadditional development of the combination. The collaboration is a primeopportunity to evaluate the potential of a new regimen for treating metastaticmelanoma.
Bristol-Myers Squibb's YERVOY 3 mg/kg received U.S. Food andDrug Administration (FDA) approval earlier this year, on March 25, and is thefisrt and only therapy with approval for the treatment of unresectable ormetastatic melanoma that demontratse a marked improvement in overall survival.
The drug is a recombinant, human monoclonal antibody that works by blocking thecytotoxic T-lymphocyte antigen-4 (CTLA-4), which is a negative regulator ofT-cell activation. YERVOY binds to CTLA-4 and blocks the interaction of theantigen with its ligands, a blocking that has proven to boost T-cell activationand proliferation.
Due to its effects in terms of T-cell activation andproliferation, YERVOY can cause immune-mediated adverse reactions that rangefrom severe to fatal, with the most common severe immune-mediated adversereactions being hepatitis, dermatitis (including toxic epidermal necrolysis),enterocolitis, neuropathy and endocrinopathy. The most common adverse reactionsto 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 isfound in almost half of all cases of melanoma.
"We have worked swiftly toadvance the vemurafenib development program, knowing that patients withmetastatic melanoma have a poor prognosis and limited treatment options," saidHal Barron M.D., Chief Medical Officer and Head of Global Product Developmentat Roche in a statement regarding the compound's New Drug Application. "Theregulatory submissions of vemurafenib and the companion diagnostic to identifypeople with the type of melanoma specifically targeted by this medicine areexciting steps toward our goal of delivering a personalized therapy for thisdisease."
Metastatic melanoma is thedeadliest form of skin cancer, and the National Cancer Institutes (NCI) predicted 68,130 new cases in the United Statesin 2010, and 8,700 deaths. It is aggressive, and prognosis is particularly poorif 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 werereleased.
