Roche and Bristol-Myers Squibb announced Thursday that they entered into a clinical collaboration agreement to investigate the combination of Roche's investigational oral BRAF inhibitor vemurafenib with Bristol-Myers Squibb’s CTLA-4 inhibitor Yervoy (ipilimumab) in patients with a specific type of metastatic melanoma. "We have made significant progress in treating metastatic melanoma and hope to further improve outcomes by combining two agents that target this deadly disease in different ways," commented Roche CMO Hal Barron.
Under the agreement, the companies will conduct a Phase I/II trial to evaluate the combination's safety and efficacy, with further studies to take place if appropriate. A spokesperson for Bristol-Myers Squibb said the study's design would be submitted to the FDA for input and the trial would be conducted in the EU and US.
The FDA approved Yervoy for the treatment of patients with unresectable metastatic melanoma in March. Vemurafenib, which Roche is developing with Daiichi Sankyo, was recently filed for approval in the US and Europe for the treatment of patients with BRAF V600 mutation-positive metastatic melanoma.
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