Merck Enters Strategic Collaborations with Amgen, Incyte and Pfizer to Evaluate Novel Combination Anti-cancer Regimens with MK-3475


February 5, 2014 6:40 am ET

Merck Also to Initiate Phase I “Signal Finding” Study with MK-3475 in 20 New Cancer Types

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today it has signed three separate clinical collaboration
agreements, through subsidiaries, with Amgen Inc., Incyte Corporation
and Pfizer Inc. to evaluate novel combination regimens with MK-3475,
Merck’s investigational anti-PD-1 immunotherapy. The financial terms of
the agreements were not disclosed.

“Merck clinical scientists intend to explore the potential of our PD-1
inhibitor across a wide range of cancers, both as monotherapy and in
combination,” said Dr. Roger M. Perlmutter, president, Merck Research
Laboratories. “These new collaborations with Amgen, Incyte and Pfizer
underscore our shared determination to evaluate treatment regimens with
the potential to provide meaningful benefits to patients suffering from

Planned investigations include:

  • Pfizer and Merck will evaluate in Phase I/II clinical studies the
    safety and efficacy of MK-3475 in combination with Pfizer’s small
    molecule kinase inhibitor axitinib (INLYTA®) in patients with renal
    cell carcinoma, and separately MK-3475 plus PF-05082566 (PF-2566), an
    investigational immuno-oncology agent that targets the human 4-1BB
    receptor, in multiple cancer types.
  • Incyte and Merck will collaborate on a randomized, double-blind
    placebo controlled Phase I/II study to evaluate the safety and
    efficacy of a regimen combining MK-3475 with Incyte’s investigational
    immunotherapy agent, INCB24360, an indoleamine 2, 3-dioxygenase (IDO)
    inhibitor, in patients with previously treated metastatic and
    recurrent NSCLC, among other advanced or metastatic cancers.
  • Amgen and Merck will evaluate MK-3475 in combination with Amgen’s
    investigational oncolytic immunotherapy talimogene laherparepvec in a
    Phase I/II study in patients with previously untreated advanced

Separately, Merck announced it will start a new Phase I “signal finding”
study to evaluate the safety and efficacy of MK-3475 monotherapy in 20
different PD-L1-positive solid tumor types that have not been studied
previously (clinical trials identifier: NCT02054806).

About MK-3475

Many tumors are able to evade the immune system through a mechanism that
exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an
investigational, highly selective anti-PD-1 immunotherapy designed to
restore the natural ability of the immune system to recognize and target
cancer cells by selectively achieving dual ligand blockade (PD-L1 and
PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation
of the immune system’s T-cells that target cancer, essentially by
releasing a brake on the immune system.

MK-3475 is being studied in 13 clinical trials estimated to enroll more
than 4,000 patients across more than 30 types of cancer including:
bladder, colorectal, gastric, head and neck, melanoma, non-small and
small cell lung, renal, pancreatic, prostate, triple negative and
estrogen-receptor positive HER 2-negative breast, gynecologic, and
hematological malignancies, among others. Additional trials, both as
monotherapy and in combination with other cancer therapies, are planned.
For information on Merck’s clinical trials please visit

Breakthrough Therapy designation for MK-3475 in advanced melanoma was
granted by the U.S. Food and Drug Administration in April 2013. Merck
announced in January the initiation of a rolling submission of a
Biologics License Application for MK-3475 in advanced melanoma in the
U.S. The company expects to complete the submission in the first half of

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit
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Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
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Risks and uncertainties include, but are not limited to, general
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including obtaining regulatory approval; Merck’s ability to accurately
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dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
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Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2012 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (

Ian McConnell, 908-423-3046
Claire Mulhearn, 908-423-7425
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

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