Merck and MD Anderson Cancer Center Announce Strategic Immuno-Oncology Research Collaboration in Solid Tumors


August 13, 2015 7:00 am ET

Clinical Trials to Evaluate Merck’s KEYTRUDA® (pembrolizumab) in Combination with Other Medicines and Treatments Across Multiple Tumor Types

KENILWORTH, N.J. & HOUSTON–(BUSINESS WIRE)–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.

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

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

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

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,

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,
and connect with us on Twitter,
and YouTube.

About MD Anderson

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 (

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at
and the Medication Guide for KEYTRUDA at

Merck Media Relations:
Pamela Eisele, 267-305-3558
An Phan, 908-255-6325
Merck Investor Relations:
Justin Holko, 908-740-1879
MD Anderson Media Relations:
Ron Gilmore, 713-745-1898

Unsubscribe from email alerts