Opinion for Pembrolizumab Based on Efficacy
and Safety Data in More than 1,500 Patients with Advanced Melanoma
as First-Line Therapy and in those Previously Treated
MSD, known as Merck (NYSE:MRK) in the United States and Canada,
today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending approval of pembrolizumab, the
company’s anti-PD-1 therapy, for the treatment of advanced
(unresectable or metastatic) melanoma as both first-line therapy
and in previously-treated patients. The CHMP positive opinion for
pembrolizumab, which is based on data in more than 1,500 adult
patients with advanced melanoma, will now be reviewed by the
European Commission for central marketing authorization in the
European Union (EU).
“MSD is committed to bringing pembrolizumab to people with
advanced melanoma in Europe as rapidly as possible, and the
positive CHMP opinion marks a significant step forward,” said Roger
Dansey, therapeutic area head and senior vice president, oncology
late stage development, Merck Research Laboratories. “We have
established a broad data set for pembrolizumab in the treatment of
advanced melanoma, and have demonstrated improvements in
progression free survival compared to chemotherapy and a survival
benefit compared to ipilimumab. We look forward to working with
European health authorities to make pembrolizumab available to
patients.”
Pembrolizumab, which will be marketed under the worldwide brand
name of KEYTRUDA, is one of the first of a new generation of
immunotherapies that works by blocking the PD-1 pathway.
Pembrolizumab was the first anti-PD-1 therapy approved in the
United States and the first medicine to be accepted under the UK’s
Early Access to Medicines Scheme (EAMS), which was introduced to
help patients benefit from promising, innovative treatments before
a European license has been granted.
Data Supporting the CHMP Positive Opinion
The positive opinion was based on data from more than 1,500
patients with advanced melanoma treated with pembrolizumab as
monotherapy in three studies – from a large Phase 1b study,
KEYNOTE-001; from a randomized, controlled study, KEYNOTE-002; and
an interim analysis from a second, randomized controlled study,
KEYNOTE-006. In KEYNOTE-001, the largest Phase 1b study to date of
an anti-PD-1 antibody, pembrolizumab demonstrated durable objective
responses in patients with advanced melanoma. KEYNOTE-002, a Phase
2 study, showed pembrolizumab was superior to chemotherapy for
progression-free survival in ipilimumab refractory advanced
melanoma. KEYNOTE-006, a Phase 3 study, showed pembrolizumab was
superior to ipilimumab for overall survival, progression-free
survival, and overall response rate. The trial was stopped early in
March 2015 based on the recommendation of the study’s independent
Data Monitoring Committee as it had met its two primary endpoints.
The CHMP recommended approval of pembrolizumab monotherapy at a
dose of 2 mg/kg every three weeks, which is the currently approved
dose for advanced melanoma in the U.S.
About Melanoma
Melanoma, the most serious form of skin cancer, is characterized
by the uncontrolled growth of pigment-producing cells. The
incidence of melanoma has been increasing over the past four
decades. In 2012, approximately 232,130 new cases were diagnosed
worldwide, and the incidence in Europe was estimated to be 100,300.
The five-year survival rates for advanced or metastatic melanoma
(Stage IV) are estimated to be 15 to 20 percent.
About Pembrolizumab
Pembrolizumab is a humanized monoclonal antibody that blocks the
interaction between PD-1 and its ligands, PD-L1 and PD-L2. By
binding to the PD-1 receptor and blocking the interaction with the
receptor ligands, pembrolizumab releases the PD-1 pathway-mediated
inhibition of the immune response, including the anti-tumor immune
response.
MSD is advancing a broad and fast-growing clinical development
program for pembrolizumab with more than 85 clinical trials –
across more than 30 tumor types and over 14,000 patients – both as
a monotherapy and in combination with other therapies.
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At MSD
Oncology, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our focus
is on pursuing research in immuno-oncology and we are accelerating
every step in the journey – from lab to clinic – to potentially
bring new hope to people with cancer.
About MSD
Today's MSD is a global healthcare leader working to help the
world be well. MSD is a trade name of Merck & Co., Inc., with
headquarters in Kenilworth, N.J., U.S.A. Through our prescription
medicines, vaccines, biologic therapies, 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.
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 MSD’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; MSD’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.
MSD 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 MSD’s/Merck’s 2014
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 (www.sec.gov).
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MSDMedia:Pam Eisele, (267) 305-3558orClaire Mulhearn, (908)
236-1118orInvestor:Joseph Romanelli, (908) 740-1986orJustin Holko,
(908) 740-1879
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