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Dec 18, 2013

Merck & Co. Joins GSK in Phase I/II Study of MK-3475

  • Merck & Co. said today it launched a Phase I/II clinical trial designed to assess the combination of its investigational anti-PD-1 immunotherapy MK-3475 and the GlaxoSmithKline (GSK) oral kinase inhibitor Votrient® (pazopanib) in advanced renal cell carcinoma.

    The trial is part of a new collaboration between the companies on MK-3475, in which Merck said it will evaluate the drug candidate in tandem with GSK drugs including pazopanib “and other agents in the GlaxoSmithKline portfolio in the future.”

    Financial terms were not disclosed.

    “We look forward to initiating further collaborations to investigate MK-3475 in combination with other anti-cancer agents across a range of tumor types,” Iain Dukes, svp, licensing and external scientific affairs, Merck Research Laboratories, said in a statement.

    He added: “Collaborations like this are central to Merck's strategy to evaluate the potential of MK-3475 for the treatment of cancer.”

    Earlier this year, Merck promised to push ahead with development of MK-3475 through creation of an integrated unit to ensure that the company is prepared to bring its investigational anti-PD-1 immunotherapy MK-3475 to patients worldwide. Merck made the commitment October 1, the very day it disclosed plans to lay off an additional 8,500 staffers by the end of 2015.

    Merck’s commitment came six months after the FDA back in April designated MK-3475 as a “breakthrough drug therapy,” in line for speedier reviews and decision-making by the agency.

    MK-3475 targets PD-1 in patients with advanced (inoperable and metastatic) melanoma. By blocking PD-1, MK-3475 is designed to enable activation of the immune system’s T cells that target cancer by essentially releasing a brake on the immune system.

    Merck said MK-3475 is being studied in 10 clinical trials estimated to enroll over 4,000 patients across a broad range of cancer types including bladder, colorectal, gastric, and head and neck cancer; melanoma; non-small cell lung, triple-negative breast, and pancreatic cancer; hematological malignancies; and renal cell carcinoma.

    Additional trials, both as a monotherapy and in combination with other cancer therapies, are planned in 2014.

    Votrient won FDA approval in 2009 for patients with advanced renal cell carcinoma—with a boxed warning for hepatotoxicity—and is now marketed in more than 80 countries. 



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