Pivotal study to evaluate Incyte’s IDO1
inhibitor in combination with Merck’s anti-PD-1 therapy in patients
with advanced or metastatic melanoma
Incyte Corporation (Nasdaq: INCY) and Merck (NYSE:MRK), known as
MSD outside the United States and Canada, today announced the
expansion of the companies’ ongoing clinical collaboration to
include a Phase 3 study evaluating the combination of epacadostat,
Incyte’s investigational selective IDO1 inhibitor, with Keytruda®
(pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment
for patients with advanced or metastatic melanoma. The Phase 3
study, which is expected to begin in the first half of 2016, will
be co-funded by Incyte and Merck.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20151013005622/en/
“We are very pleased to expand our collaboration with Merck and
to move the clinical development program for epacadostat in
combination with Keytruda into Phase 3,” said Hervé Hoppenot,
President and Chief Executive Officer of Incyte. “We believe the
combination of these two immunotherapies shows promise and, if
successfully developed, may help to improve clinical outcomes for
patients with metastatic melanoma.”
“The initiation of this large Phase 3 study with Incyte in the
first-line advanced melanoma treatment setting is an important
addition to our robust immunotherapy clinical development program
for Keytruda,” said Dr. Roger Dansey, senior vice president and
therapeutic area head, oncology late-stage development, Merck
Research Laboratories. “We continue to explore the benefit that
Keytruda brings to patients suffering from advanced melanoma when
used alone, and we are pleased to be able to add this important
combination study with epacadostat to our Keytruda development
program.”
Under the terms of the agreement Incyte and Merck have also
agreed, for a period of two years, not to initiate new pivotal
studies of an IDO1 inhibitor in combination with a PD-1/PD-L1
antagonist as first-line therapy in advanced or metastatic melanoma
with any third party. During this time, the companies will each
offer the other the opportunity to collaborate on any new pivotal
study involving an IDO1 inhibitor in combination with a PD-1/PD-L1
antagonist for types of melanoma and lines of therapy outside of
the current collaboration agreement.
The agreement is between Incyte and certain subsidiaries and
Merck through its subsidiaries.
Epacadostat and Keytruda are part of a class of cancer
treatments known as immunotherapies that are designed to enhance
the body’s own defenses in fighting cancer; the two therapies
target distinct regulatory components of the immune system. IDO1 is
an immunosuppressive enzyme that has been shown to induce
regulatory T cell generation and activation, and allow tumors to
escape immune surveillance. Keytruda is a humanized monoclonal
antibody that blocks the interaction between PD-1 and its ligands,
PD-L1 and PD-L2. Preclinical evidence suggests that the combination
of these two agents may lead to an enhanced anti-tumor immune
response compared with either agent alone.
Safety and efficacy data from the ongoing Phase 1/2 study
evaluating the combination of epacadostat with Keytruda in patients
with advanced malignancies is scheduled to be highlighted as a
late-breaking oral presentation (Abstract #142) at the upcoming
Society for Immunotherapy of Cancer 30th Anniversary Annual Meeting
& Associated Programs, November 4–8, 2015 at the Gaylord
National Resort & Convention Center in National Harbor, MD.
Metastatic Melanoma
Melanoma, the most serious form of skin cancer, strikes adults
of all ages and accounts for approximately five percent of all new
cases of cancer in the United States each year. The number of new
cases of melanoma continues to rise by almost three percent each
year which translates to 76,000 new cases yearly in the U.S.
alone.1 The 5-year survival rate for late-stage or metastatic
disease is 15 percent.2
About Epacadostat (INCB024360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive
enzyme that has been shown to induce regulatory T cell generation
and activation, and allow tumors to escape immune surveillance.
Epacadostat is an orally bioavailable small molecule inhibitor of
IDO1 that has nanomolar potency in both biochemical and cellular
assays and has demonstrated potent activity in enhancing T
lymphocyte, dendritic cell and natural killer cell responses in
vitro, with a high degree of selectivity. Epacadostat has shown
proof-of-concept clinical data in patients with unresectable or
metastatic melanoma in combination with the CTLA-4 inhibitor
ipilimumab, and is currently in four proof-of-concept clinical
trials with PD-1 and PD-L1 immune checkpoint inhibitors in a
variety of cancer histologies.
About Keytruda® (pembrolizumab) Injection 100mg In
Melanoma
Keytruda 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, Keytruda releases the PD-1 pathway-mediated
inhibition of the immune response, including the anti-tumor immune
response. Keytruda is indicated for the treatment of patients with
unresectable or metastatic melanoma and disease progression
following ipilimumab and, if BRAF V600 mutation positive, a BRAF
inhibitor. This indication is approved under accelerated approval
based on tumor response rate and durability of response. An
improvement in survival or disease-related symptoms has not yet
been established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
Selected Important Safety Information for Keytruda in
Melanoma Trials
Pneumonitis occurred in 12 (2.9%) of 411 patients, including
Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively,
receiving Keytruda. Monitor patients for signs and symptoms of
pneumonitis. Evaluate suspected pneumonitis with radiographic
imaging. Administer corticosteroids for Grade 2 or greater
pneumonitis. Withhold Keytruda for Grade 2; permanently discontinue
Keytruda for Grade 3 or 4 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of
411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%)
patients, respectively, receiving Keytruda. Monitor patients for
signs and symptoms of colitis. Administer corticosteroids for Grade
2 or greater colitis. Withhold Keytruda for Grade 2 or 3;
permanently discontinue Keytruda for Grade 4 colitis.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%)
of 411 patients, including a Grade 4 case in 1 (0.2%) patient,
receiving Keytruda. Monitor patients for changes in liver function.
Administer corticosteroids for Grade 2 or greater hepatitis and,
based on severity of liver enzyme elevations, withhold or
discontinue Keytruda.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a
Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient,
receiving Keytruda. Monitor patients for signs and symptoms of
hypophysitis (including hypopituitarism and adrenal insufficiency).
Administer corticosteroids for Grade 2 or greater hypophysitis.
Withhold Keytruda for Grade 2; withhold or discontinue for Grade 3;
and permanently discontinue Keytruda for Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including
Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively,
receiving Keytruda. Hypothyroidism occurred in 34 (8.3%) of 411
patients, including a Grade 3 case in 1 (0.2%) patient, receiving
Keytruda. Thyroid disorders can occur at any time during treatment.
Monitor patients for changes in thyroid function (at the start of
treatment, periodically during treatment, and as indicated based on
clinical evaluation) and for clinical signs and symptoms of thyroid
disorders. Administer corticosteroids for Grade 3 or greater
hyperthyroidism. Withhold Keytruda for Grade 3; permanently
discontinue Keytruda for Grade 4 hyperthyroidism. Isolated
hypothyroidism may be managed with replacement therapy without
treatment interruption and without corticosteroids.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has
occurred in patients receiving Keytruda. Monitor patients for
hyperglycemia and other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold Keytruda in cases of
severe hyperglycemia until metabolic control is achieved.
Nephritis occurred in 3 (0.7%) patients, consisting of one case
of Grade 2 autoimmune nephritis (0.2%) and two cases of
interstitial nephritis with renal failure (0.5%), one Grade 3 and
one Grade 4. Monitor patients for changes in renal function.
Administer corticosteroids for Grade 2 or greater nephritis.
Withhold Keytruda for Grade 2; permanently discontinue Keytruda for
Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can
occur. The following clinically significant immune-mediated adverse
reactions occurred in patients treated with Keytruda: exfoliative
dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic
anemia, partial seizures arising in a patient with inflammatory
foci in brain parenchyma, severe dermatitis including bullous
pemphigoid, myasthenic syndrome, optic neuritis, and
rhabdomyolysis.
For suspected immune-mediated adverse reactions, ensure adequate
evaluation to confirm etiology or exclude other causes. Based on
the severity of the adverse reaction, withhold Keytruda and
administer corticosteroids. Upon improvement of the adverse
reaction to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Restart Keytruda if the
adverse reaction remains at Grade 1 or less. Permanently
discontinue Keytruda for any severe or Grade 3 immune-mediated
adverse reaction that recurs and for any life-threatening
immune-mediated adverse reaction.
Infusion-related reactions, including severe and
life-threatening reactions, have occurred in patients receiving
Keytruda. Monitor patients for signs and symptoms of
infusion-related reactions including rigors, chills, wheezing,
pruritus, flushing, rash, hypotension, hypoxemia, and fever. For
severe or life-threatening reactions, stop infusion and permanently
discontinue Keytruda.
Based on its mechanism of action, Keytruda may cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of Keytruda.
Keytruda was discontinued for adverse reactions in 9% of 411
patients. Adverse reactions, reported in at least two patients,
that led to discontinuation of Keytruda were: pneumonitis, renal
failure, and pain. Serious adverse reactions occurred in 36% of
patients. The most frequent serious adverse reactions, reported in
2% or more of patients, were renal failure, dyspnea, pneumonia, and
cellulitis.
The most common adverse reactions (reported in at least 20% of
patients) were fatigue (47%), cough (30%), nausea (30%), pruritus
(30%), rash (29%), decreased appetite (26%), constipation (21%),
arthralgia (20%), and diarrhea (20%).
No formal pharmacokinetic drug interaction studies have been
conducted with Keytruda.
It is not known whether Keytruda is excreted in human milk.
Because many drugs are excreted in human milk, instruct women to
discontinue nursing during treatment with Keytruda.
The recommended dose of Keytruda (pembrolizumab) is 2 mg/kg
administered as an intravenous infusion over 30 minutes every three
weeks until disease progression or unacceptable toxicity. No formal
pharmacokinetic drug interaction studies have been conducted with
Keytruda. It is not known whether Keytruda is excreted in human
milk. Because many drugs are excreted in human milk, instruct women
to discontinue nursing during treatment with Keytruda. Safety and
effectiveness of Keytruda have not been established in pediatric
patients.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics, primarily for
oncology. For additional information on Incyte, please visit the
Company’s website at www.incyte.com.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck
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. For more
information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States
and Canada. 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. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement of Incyte
Except for the historical information set forth herein, the
matters set forth in this press release, including without
limitation statements with respect to the planned commencement of
the Phase 3 trial for epacadostat in combination with pembrolizumab
for advanced or metastatic melanoma, the efficacy of such trial and
the effect such trial may have on patient outcomes, the planned
presentation of safety and efficacy data from the ongoing Phase 1/2
study for epacadostat in combination with Keytruda, and the
parties’ future obligations under the expanded collaboration
agreement, contain predictions and estimates and are
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including the high degree of
risk associated with drug development, results of further research
and development, unanticipated delays, other market or economic
factors and technological advances, regulatory approval of the
transaction and other risks detailed from time to time in Incyte's
filings with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2015.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, NJ, USA
(the “Company”) 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 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 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; 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 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 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).
Please see Prescribing Information for KEYTRUDA
(pembrolizumab) at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
and the Medication Guide for KEYTRUDA at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
1 Siegel R, Naishadham MA, Jemal A. Cancer statistics, 2012. CA
Cancer J Clin. Jan- 2012;62:10-29.
2 American Cancer Society. Melanoma Skin Cancer. Atlanta, GA:
American Cancer Society (ACS); 2015.
http://www.cancer.org/cancer/skincancer-melanoma/index. Accessed
May 13, 2015.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151013005622/en/
Merck Media Relations:Pamela Eisele, 267-305-3558An Phan,
908-255-6325orMerck Investor Relations:Teri Loxam,
908-740-1986Justin Holko, 908-740-1879orIncyte Media
Relations:Catalina Loveman,
302-498-6171cloveman@incyte.comorIncyte Investor
Relations:Michael Booth, DPhil302-498-5914mbooth@incyte.com
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024