Reinforces Important Progress in Merck’s
Oncology Pipeline to Advance Novel Therapeutic Candidates
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that the U.S. Food and Drug Administration
(FDA) has granted Breakthrough Therapy designation to the
hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a
novel investigational candidate in Merck’s oncology pipeline, for
the treatment of patients with von Hippel-Lindau (VHL)
disease-associated renal cell carcinoma (RCC) with nonmetastatic
RCC tumors less than three centimeters in size, unless immediate
surgery is required. The FDA also granted orphan drug designation
to MK-6482 for VHL disease. These designations are based on data
from a Phase 2 trial evaluating MK-6482 in patients with
VHL-associated clear cell RCC, which were presented at the 2020
American Society of Clinical Oncology Annual Meeting.
“Merck’s diverse and expansive oncology pipeline is focused on
bringing forward innovative new treatments to patients in need and
continues to show important progress,” said Dr. Scot Ebbinghaus,
vice president, clinical research, Merck Research Laboratories.
“These designations for MK-6482 support the potential of targeting
HIF-2α in certain patients with von Hippel-Lindau disease, who
currently have limited treatment options and face an increased risk
for benign tumors as well as several types of cancer, including
renal cell carcinoma.”
The FDA’s Breakthrough Therapy designation is granted to
expedite the development and review of medicines that are intended
to treat serious or life-threatening conditions and that have
demonstrated preliminary clinical evidence indicating that the
medicine may provide a substantial improvement over available
therapy on at least one clinically significant endpoint. The FDA’s
orphan drug designation is granted to medicines that are intended
for the treatment, prevention or diagnosis of rare diseases that
affect fewer than 200,000 people in the U.S.
About MK-6482
MK-6482 (formerly PT2977) is an investigational, novel, potent,
selective, oral HIF-2α inhibitor that is currently being evaluated
in a Phase 3 trial in advanced RCC (NCT04195750), a Phase 2 trial
in VHL-associated RCC (NCT03401788), and a Phase 1/2
dose-escalation and dose-expansion trial in advanced solid tumors,
including advanced RCC (NCT02974738). Proteins known as
hypoxia-inducible factors, including HIF-2α, can accumulate in
patients when VHL, a tumor-suppressor protein, is inactivated. The
accumulation of HIF-2α can lead to the formation of both benign and
malignant tumors. This inactivation of VHL has been observed in
more than 90% of ccRCC tumors. Research into VHL biology that led
to the discovery of HIF-2α was awarded the Nobel Prize in
Physiology or Medicine in 2019.
About Von Hippel-Lindau Disease and Renal Cell Carcinoma
Von Hippel-Lindau disease is a rare genetic disease that affects
one in 36,000 people (200,000 cases worldwide and 10,000 cases in
the U.S. alone). Patients with VHL disease are at risk for benign
blood vessel tumors as well as several cancers, including RCC. As
many as 60% of people with VHL disease develop RCC, which is a
leading cause of death for patients with VHL disease.
Renal cell carcinoma is by far the most common type of kidney
cancer; about nine of 10 kidney cancers are RCCs, and about seven
of 10 RCCs are clear cell. Worldwide, it is estimated there were
about 403,000 cases of kidney cancer diagnosed and about 175,000
deaths from the disease in 2018. In the U.S. alone, it is estimated
there will be nearly 74,000 new cases of kidney cancer diagnosed
and almost 15,000 deaths from the disease in 2020.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck,
the potential to bring new hope to people with cancer drives our
purpose and supporting accessibility to our cancer medicines is our
commitment. As part of our focus on cancer, Merck is committed to
exploring the potential of immuno-oncology with one of the largest
development programs in the industry across more than 30 tumor
types. We also continue to strengthen our portfolio through
strategic acquisitions and are prioritizing the development of
several promising oncology candidates with the potential to improve
the treatment of advanced cancers. For more information about our
oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’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 the recent global outbreak of novel coronavirus
disease (COVID-19); 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; the company’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
the company’s patents and other protections for innovative
products; and the exposure to litigation, including patent
litigation, and/or regulatory actions.
The company 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 the company’s 2019
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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