Merck Collaborates with GlaxoSmithKline to Evaluate Novel Combination Regimen for Advanced Renal Cell Carcinoma


December 18, 2013 7:30 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the initiation of a clinical trial to evaluate the
combination of the company’s investigational anti-PD-1 immunotherapy,
MK-3475, and GlaxoSmithKline’s orally administered kinase inhibitor,
pazopanib, in advanced renal cell carcinoma.

“Collaborations like this are central to Merck’s strategy to evaluate
the potential of MK-3475 for the treatment of cancer,” said Iain Dukes,
senior vice president, Licensing and External Scientific Affairs, Merck
Research Laboratories. “We look forward to initiating further
collaborations to investigate MK-3475 in combination with other
anti-cancer agents across a range of tumor types.”

Merck and GlaxoSmithKline entered a collaboration to study MK-3475 with
pazopanib and other agents in the GlaxoSmithKline portfolio in the
future. This Phase I/II clinical trial is designed to evaluate the
safety and efficacy of a combination of MK-3475 and pazopanib in
treatment naïve patients with advanced renal cell carcinoma. Further
details of the collaboration were not disclosed.

About pazopanib

Pazopanib was approved by the US Food and Drug Administration for the
treatment of patients with advanced renal cell carcinoma in October 2009
and is marketed under the trade name Votrient®. It is now approved in
more than 80 countries. For full US Prescribing Information including
BOXED WARNING for hepatotoxicity and Medication Guide, please visit:

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 by essentially
releasing a brake on the immune system.

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, head and neck, melanoma, non-small cell lung,
triple negative breast, pancreatic, hematological malignancies and renal
cell carcinoma. Additional trials, as monotherapy and in combination
with other cancer therapies, are planned in 2014. For information on
Merck’s clinical trials please visit

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
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

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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