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news.Japanese pharmaceutical firm Eisai has entered into clinical trial collaboration with Merck to discover new combination regimens of anti-PD-1 therapy with multi-targeting RTK inhibitor and microtubule dynamics inhibitor to treat multiple types of cancer.
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The deal will see evaluation of the safety, tolerability and efficacy of Merck’s anti-PD-1 therapy, pembrolizumab (KEYTRUDA in US), in combination with Eisai oncology compounds lenvatinib mesylate (Lenvima) and eribulin mesylate (Halaven) in multiple clinical trials.
Eisai’s lenvatinib mesylate is a multi-targeting RTK inhibitor marketed in the US under the brand name Lenvima, while eribulin mesylate is a microtubule dynamics inhibitor marketed in nearly 60 countries including Japan, the US, and Europe under the brand name Halaven.
The two planned trials, which are scheduled to be initiated in the second half of 2015, include a multicenter, open-label Phase Ib/II trial of lenvatinib plus pembrolizumab in select solid tumors and the second is an open-label, single-arm, multicenter Phase Ib/II trial designed to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in metastatic triple-negative breast cancer.
Merck Research Laboratories therapeutic area head oncology early-stage development Dr Eric Rubin said: "Cancer is a complex disease that often requires different approaches to help patients achieve the best possible outcome."
Eisai Product Creation Systems president oncology product creation unit Kenichi Nomoto said: "This collaboration could be a major step in the direction of developing combination regimens in different types of cancer, potentially maximizing the value of eribulin and lenvatinib."
A Joint Development Committee will be established by the two companies in order to manage clinical development activities.
According to the company, the combinations of lenvatinib and pembrolizumab, and eribulin and pembrolizumab are investigational, while the efficacy and safety of these combinations have not been established.