Merck & Co. and Amgen on Friday announced an expansion to an existing collaboration, under which the companies plan to conduct a Phase I study evaluating the anti-PD-1 therapy Keytruda (pembrolizumab) in combination with the oncolytic immunotherapy
talimogene laherparepvec (T-Vec) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The companies also said they will initiate a Phase III study of the combination in patients with regionally or distantly metastatic melanoma.
Last year, Merck and Amgen announced plans to conduct clinical trials of the combination for the treatment of regionally or distantly metastatic melanoma. Sean E. Harper, executive vice president of R&D at Amgen, said "we will discuss the design of the Phase III melanoma trial with global regulators and look forward to collaborating with Merck on this study."
Harper commented "we believe that [T-Vec] has potential in several cancer types based on its proposed mechanism of action to initiate tumour antigen release and presentation, important steps in activating a systemic anti-tumour immune response." The executive added that the two drugs "are designed to result in anti-tumour immune responses through different and potentially complementary mechanisms of action."
Merck's Keytruda was approved by the FDA last year for the treatment of advanced or unresectable melanoma, marking the first authorisation of a PD-1 inhibitor by the agency. Meanwhile, the European Medicines Agency's Committee for Medicinal Products for Human Use recently recommended clearance of the drug for patients with advanced melanoma. In April, Merck disclosed that the therapy had also been submitted to the FDA for approval for the treatment for advanced non-small-cell lung cancer, for which the drug has been awarded breakthrough therapy status.
Last month, an FDA advisory panel voted 22-1 to recommend approval of Amgen's T-Vec for the treatment of metastatic melanoma, with the agency expected to issue a final decision by October 27 (for related analysis, see ViewPoints: Thumbs up for T-Vec a big plus for Amgen, oncolytic viruses and perhaps biotech in general).
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