THOUSAND OAKS, Calif. and
KENILWORTH, N.J., May 29, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN)
and Merck (NYSE: MRK), known as MSD outside the U.S. and
Canada, today announced an
expanded collaboration to evaluate the efficacy and safety of
talimogene laherparepvec, Amgen's investigational oncolytic
immunotherapy, in combination with KEYTRUDA®
(pembrolizumab), Merck's anti-PD-1 therapy, in a Phase 1,
open-label trial of patients with recurrent or metastatic squamous
cell carcinoma of the head and neck (SCCHN).
In addition, the companies announced that a global, randomized
Phase 3 trial evaluating the combination in patients with
regionally or distantly metastatic melanoma is being initiated. As
previously announced, the compounds are being studied in a Phase 1,
open-label trial in this patient population.
Both immunotherapies are designed to modulate the immune system.
Talimogene laherparepvec is an investigational oncolytic
immunotherapy designed to selectively replicate in tumors (but not
normal tissue) and to initiate an immune response against cancer
cells. KEYTRUDA is a humanized monoclonal antibody that blocks the
interaction between PD-1 (programmed death receptor-1) and its
ligands, PD-L1 and PD-L2.
"We believe that talimogene laherparepvec has potential in
several cancer types based on its proposed mechanism of action to
initiate tumor antigen release and presentation, important steps in
activating a systemic anti-tumor immune response," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "Talimogene
laherparepvec and KEYTRUDA are designed to result in anti-tumor
immune responses through different and potentially complementary
mechanisms of action. We hope these trials will provide us with
insights on the combination of these therapies for patients with
this form of cancer for whom treatment options are currently
limited. We will discuss the design of the Phase 3 melanoma trial
with global regulators and look forward to collaborating with Merck
on this study."
"Expanding our collaboration with Amgen is a testament to our
belief in the potential for immuno-oncology therapies to change the
way we approach the treatment of many cancers, including advanced
head and neck cancer where the options are limited," said Dr.
Eric Rubin, vice president and
therapeutic head, oncology early stage development, Merck Research
Laboratories. "We look forward to studying the combination
of talimogene laherparepvec and KEYTRUDA in head and
neck cancer, and to advancing our collaboration in metastatic
melanoma into a Phase 3 clinical trial."
About Squamous Cell Carcinoma of the Head and
Neck
Squamous cell carcinomas of the head and neck (SCCHN)
are cancers that begin in the squamous cells that line the mucosal
surfaces inside the head and neck.1 This includes
cancers of the nasal cavity, sinuses, lips, mouth, salivary glands,
throat, and larynx.2 SCCHN is the sixth most common type
of cancer, representing approximately 6 percent of all new
cases.3 It is thought to account for an estimated
650,000 new cancer cases and 350,000 cancer deaths worldwide per
year.3-5
About Talimogene Laherparepvec
Talimogene
laherparepvec is an investigational oncolytic immunotherapy
designed to selectively replicate in tumors (but not normal tissue)
and to initiate an immune response to target cancer cells that have
metastasized. Talimogene laherparepvec was designed to work in two
important and complementary ways. First, it is injected directly
into tumors where it replicates inside the tumor's cells causing
the cell to rupture and die in a process called lysis. Then, the
rupture of the cancer cells can release tumor-derived antigens,
along with GM-CSF, that can stimulate a system-wide immune response
where white blood cells are able to seek out and target cancer that
has spread throughout the body.
Amgen has initiated a comprehensive clinical development program
for talimogene laherparepvec in metastatic melanoma, which includes
combination studies with checkpoint inhibitors in patients with
late-stage disease and monotherapy prior to surgery (neoadjuvant)
in patients with resectable disease. Additionally, based on its
clinical profile, talimogene laherparepvec has the potential to be
studied in a variety of solid tumor types.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA (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, 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. 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.
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.
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 for Grade 2; permanently discontinue
KEYTRUDA for Grade 3 or 4 nephritis.
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.
Other clinically important immune-mediated adverse reactions can
occur. The following clinically significant, immune-mediated
adverse reactions occurred in less than 1% of patients treated with
KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis,
pancreatitis, hemolytic anemia, partial seizures arising in a
patient with inflammatory foci in brain parenchyma, adrenal
insufficiency, 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.
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 6% of 89 patients who
received the recommended dose of 2 mg/kg and 9% of 411 patients
across all doses studied. 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. 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 Amgen
Amgen is committed to unlocking the potential of biology for
patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its biologics manufacturing expertise to strive for
solutions that improve health outcomes and dramatically improve
people's lives. A biotechnology pioneer since
1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
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.
Amgen Forward-Looking Statement
This news release
contains forward-looking statements that are based on the current
expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen)
and are subject to a number of risks, uncertainties and assumptions
that could cause actual results to differ materially from those
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Inc.'s most recent annual report on Form 10-K and any subsequent
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Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional
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Amgen's business. Unless otherwise noted, Amgen is providing
this information as of May 29, 2015,
and expressly disclaims any duty to update information contained in
this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those Amgen projects.
Discovery or identification of new product candidates or
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candidate or development of a new indication for an existing
product will be successful and become a commercial product.
Further, preclinical results do not guarantee safe and effective
performance of product candidates in humans. The complexity
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adequately modeled by computer or cell culture systems or animal
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partners to complete clinical trials and obtain regulatory approval
for product marketing has in the past varied and Amgen expects
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In addition, sales of Amgen's products (including products of
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of its marketed products as well as for the discovery and
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newer products, product candidates or new indications for existing
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commercial success of its existing products. Amgen's stock
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Merck 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 Merck'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; Merck'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.
Merck 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 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).
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
CONTACTS:
Amgen (Thousand Oaks):
Kristen Davis,
805-447-3008 (media)
Trish Hawkins, 805-447-5631
(media)
Arvind Sood, 805-447-1060
(investors)
Merck:
Pamela Eisele: (267) 305-3558
(media)
Claire Mulhearn: (908) 236-1118
(media)
Justin Holko: (908) 740-1879
(investors)
References:
- National Cancer Institute. "Head and Neck Cancers." Available
at:
http://www.cancer.gov/cancertopics/factsheet/Sites-Types/head-and-neck.
Accessed December 11, 2014.
- National Cancer Institute. "NCI Dictionary of Cancer Terms."
Available at: http://www.cancer.gov/dictionary?cdrid=597171.
Accessed December 11, 2014.
- Haddad RI, Shin DM. Recent advances in head and neck cancer. N
Engl J Med2008;359:1143-1154.
- Murar S, Forastiere AA. Head and neck cancer: changing
epidemiology, diagnosis, and treatment. Mayo Clin Proc 2008;83:489-501.
- Parkin DM, Bray F, Ferlay J, Pisani P (2005) Global cancer
statistics, 2002. CA Cancer J Clin 55: 74-108.
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