Clinical Trials to Evaluate Merck’s
KEYTRUDA® (pembrolizumab) in Combination with Other
Medicines and Treatments Across Multiple Tumor Types
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and The University of Texas MD Anderson Cancer Center today
announced that they have entered into a strategic clinical research
collaboration to evaluate Merck’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab), in combination with other treatments, such as
chemotherapy, radiation therapy and/or novel antitumor
medicines.
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Under the terms of the agreement, collaborative studies will be
conducted in the following tumor types: gastroesophageal
adenocarcinoma, pancreatic adenocarcinoma, and hepatocellular
carcinoma -- over the three year period of the collaboration. The
first studies are scheduled to start enrolling later this year.
The agreement aims to define what combination modalities will
work best with KEYTRUDA in these types of tumors by exploring
promising new alternatives. The studies will be conducted in
parallel, in order to determine optimal regimens in the most
efficient manner possible. All studies will feature
state-of-the-art monitoring protocols and built-in flexibility to
take advantage of the very latest information available.
“Through these types of collaborations, we are able to engage in
larger, more comprehensive studies that aim to accelerate the pace
of discovery,” said Patrick Hwu, M.D., division head, cancer
medicine at MD Anderson. “We believe that this new agreement will
help to speed delivery of new cancer treatments that our patients
expect and deserve.”
“This agreement embodies Merck’s commitment to collaborating
with leaders in the field to rapidly advance breakthrough science
and further the goal of bringing new treatment approaches to
patients,” said Dr. Roger Dansey, senior vice president and
therapeutic area head, oncology late-stage development, Merck
Research Laboratories. “Agreements like this are an integral part
of our strategy to evaluate KEYTRUDA in multiple tumors and
combinations.”
MD Anderson is a world-recognized academic research institution
that has consistently led the charge in researching breakthrough
cancer therapies, and was a key contributor to early investigations
exploring the use of KEYTRUDA in the treatment of multiple tumor
types. Past research collaborations with Merck and MD Anderson were
pivotal in achieving the FDA approval of KEYTRUDA as a treatment
for unresectable or metastatic melanoma.
About KEYTRUDA® (pembrolizumab)
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 in the United States at a dose of 2 mg/kg
administered as an intravenous infusion over 30 minutes every three
weeks 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.
Merck is advancing a broad and fast-growing clinical development
program for KEYTRUDA with more than 100 clinical trials – across
more than 30 tumor types and enrolling more than 16,000 patients –
both as a monotherapy and in combination with other therapies.
Selected Important Safety Information for KEYTRUDA
Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced
melanoma receiving KEYTRUDA (the approved indication in the United
States), including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%)
patients, respectively. 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 (pembrolizumab). 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 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 receiving KEYTRUDA,
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 (pembrolizumab) 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
(pembrolizumab): 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.
For the treatment of advanced melanoma, KEYTRUDA was
discontinued for adverse reactions in 9% of 411 patients across all
doses studied. Adverse reactions, reported in at least two
patients, that led to discontinuations of KEYTRUDA were:
pneumonitis, renal failure, and pain. Serious adverse reactions
occurred in 36% of patients receiving KEYTRUDA. The most frequent
serious adverse drug reactions reported in 2% or more of patients
were renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in ≥20% of patients)
were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash
(29%), decreased appetite (26%), constipation (21%), arthralgia
(20%), and diarrhea (20%).
The recommended dose of KEYTRUDA 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 (pembrolizumab). 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.
Our 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 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.
About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston
ranks as one of the world's most respected centers focused on
cancer patient care, research, education and prevention. The
institution’s sole mission is to end cancer for patients and their
families around the world. MD Anderson is one of only 44
comprehensive cancer centers designated by the National Cancer
Institute (NCI). MD Anderson is ranked No. 1 for cancer care in the
U.S. News & World Report’s “Best Hospital’s” survey. It has
ranked as one of the nation’s top two hospitals since the survey
began in 1990, and has ranked first 11 of the past 14 years. MD
Anderson receives a cancer center support grant from the NCI of the
National Institutes of Health (P30 CA016672).
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.
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Merck Media Relations:Pamela Eisele, 267-305-3558orAn Phan,
908-255-6325orMerck Investor Relations:Justin Holko,
908-740-1879orMD Anderson Media Relations:Ron Gilmore,
713-745-1898Rlgilmore1@mdanderson.org
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