Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma


January 13, 2014 8:30 am ET

Expects to Complete Application in First Half of 2014

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
said today it has started a rolling submission to the U.S. Food and Drug
Administration (FDA) of a Biologics License Application for MK-3475, the
company’s investigational anti-PD-1 immunotherapy, for patients with
advanced melanoma who have been previously treated with ipilimumab. A
rolling submission allows completed portions of the application to be
submitted and reviewed by the FDA on an ongoing basis. The company
expects to complete the application in the first half of 2014.

“Our MK-3475 is a novel immunomodulatory molecule that holds promise for
patients with advanced malignancy who now have limited treatment
options,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck
Research Laboratories. “Initiation of this rolling submission represents
an important milestone in the MK-3475 clinical development program for
patients suffering from malignant melanoma.”

Clinical Development of MK-3475 in Advanced Melanoma

MK-3475 is currently being studied in three clinical trials for advanced
melanoma including a Phase III trial of MK-3475 versus ipilimumab in
ipilimumab-naïve advanced melanoma patients (PN 006). Enrollment is
complete in the advanced melanoma cohorts in the company’s Phase IB
trial (PN 001) and the Phase II trial (PN 002) comparing two doses of
MK-3475 versus chemotherapy in patients with advanced melanoma who have
progressed after prior therapy. In April 2013, Merck announced that
MK-3475 received a Breakthrough Therapy designation for advanced
melanoma from the FDA.

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 currently being studied in 10 clinical trials estimated to
enroll more than 4,000 patients across a broad range of cancer types
including: bladder, colorectal, gastric, head and neck, melanoma,
non-small cell lung, renal, triple negative breast and hematological
malignancies. Additional trials, both as monotherapy and in combination
with other cancer therapies, are planned. For information on Merck’s
clinical trials please visit

About Advanced Melanoma

Melanoma is the most dangerous type of skin cancer. While it accounts
for only 5 percent of all cases, melanoma is the cause of 75 percent of
skin cancer deaths. According to the American Cancer Society, an
estimated 9,180 people in the U.S. died from advanced melanoma in 2012.

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 healthcare legislation in the
United States and internationally; global trends toward healthcare 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, 908-500-1101
Justin Holko, 908-423-5088

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