Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma


June 30, 2014 5:00 am ET

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the European Medicines Agency (EMA) has accepted for
review a Marketing Authorization Application (MAA) for pembrolizumab
(MK-3475), the company’s investigational anti-PD-1 antibody, for the
treatment of advanced melanoma. If approved by the European Commission
(EC), pembrolizumab has the potential to be the first anti-PD-1 therapy
in Europe. Additional regulatory filings in other countries outside of
Europe are planned by the end of 2014.

“With the five-year survival rate for patients with advanced melanoma at
less than 20 percent, there remains a need to offer patients additional
options,” said Dr. Roy Baynes, senior vice president, clinical
development, Merck Research Laboratories. “We are pleased to have
regulatory applications under review in the United States and Europe as
we work toward bringing pembrolizumab to patients around the world.”

About Advanced Melanoma

Melanoma is the most serious form of skin cancer and is the 19th
most common cause of cancer death in Europe. In 2012, there were an
estimated 22,200 deaths from malignant melanoma in Europe. There were an
estimated 232,000 new cases of melanoma diagnosed worldwide in 2012.

About Pembrolizumab

Pembrolizumab (MK-3475) is an investigational, selective, humanized,
monoclonal anti-PD-1 antibody designed to reactivate anti-tumor
immunity. Pembrolizumab exerts dual ligand blockade of the PD-1 pathway
by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1
and PD-L2.

Today, pembrolizumab is being evaluated across more than 30 types of
cancers, as monotherapy and in combination. It is anticipated that by
the end of 2014, the pembrolizumab development program will grow to more
than 24 clinical trials, enrolling an estimated 6,000 patients at nearly
300 clinical trial sites worldwide. For information about Merck’s
oncology clinical studies, please visit

The Biologics
License Application (BLA) for pembrolizumab is under priority review

with the U.S. Food and Drug Administration (FDA) for the treatment of
patients with advanced melanoma previously-treated with ipilimumab; the
PDUFA date is October 28, 2014. Pembrolizumab has been granted FDA’s
Breakthrough Therapy designation for advanced melanoma. If approved by
the FDA, pembrolizumab has the potential to be the first anti-PD-1
therapy approved within the United States.

About Merck Oncology

At Merck Oncology, our goal is to translate breakthrough science into
biomedical innovations to help people with cancer worldwide. Harnessing
immune mechanisms to fight cancer is the priority focus of our oncology
research and development program. The Company is advancing a pipeline of
immunotherapy candidates and combination regimens. Cancer is one of the
world’s most urgent unmet medical needs. Helping to empower people to
fight cancer is our passion. For information about Merck’s commitment to
Oncology visit the Oncology Information Center at

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
and connect with us on Twitter,
and YouTube.

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 2013 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 (

Steve Cragle, 973-432-4781
Claire Mulhear, 908-423-7425
Joseph Romanelli, 908-423-5185
Justin Holko, 908-423-5088

Unsubscribe from email alerts