Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the supplemental Biologics License
Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s
anti-PD-1 therapy, for the treatment of patients with recurrent or
metastatic head and neck squamous cell carcinoma (HNSCC) with
disease progression on or after platinum-containing chemotherapy.
The application is seeking approval for KEYTRUDA as a single agent
at a dose of 200 mg administered intravenously every three weeks.
The FDA granted Priority Review with a PDUFA, or target action,
date of Aug. 9; the sBLA will be reviewed under the FDA’s
Accelerated Approval program.
“Starting in the early days of our development program, we have
explored the role of KEYTRUDA for patients with head and neck
cancer, a difficult-to-treat and debilitating disease with very few
treatment options,” said Roger Dansey, M.D., senior vice president
and therapeutic area head, oncology late-stage development, Merck
Research Laboratories. “We are encouraged by the data emerging from
our program in this type of cancer, and welcome today’s news as
this is an important step toward making KEYTRUDA available to these
patients.”
Merck currently has the largest immuno-oncology clinical
development program in head and neck cancer and is advancing
multiple registration-enabling studies with KEYTRUDA as a single
agent and in combination with chemotherapy.
About KEYTRUDA® (pembrolizumab) Injection 100
mg
KEYTRUDA is a humanized monoclonal antibody that works by
increasing the ability of the body’s immune system to help detect
and fight tumor cells. KEYTRUDA blocks the interaction between PD-1
and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes
which may affect both tumor cells and healthy cells.
KEYTRUDA is indicated in the United States for the treatment of
patients with unresectable or metastatic melanoma.
KEYTRUDA is also indicated for the treatment of patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors express
PD-L1 as determined by an FDA-approved test with disease
progression on or after platinum-containing chemotherapy. Patients
with EGFR or ALK genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations prior to
receiving KEYTRUDA. The NSCLC 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.
KEYTRUDA is administered at a dose of 2 mg/kg as an intravenous
infusion over 30 minutes every three weeks for the approved
indications.
About Head and Neck Cancer
Head and neck cancer describes a number of different tumors that
develop in or around the throat, larynx, nose, sinuses and mouth.
Most head and neck cancers are squamous cell carcinomas that begin
in the flat, squamous cells that make up the thin surface layer of
the structures in the head and neck. The leading modifiable risk
factors for head and neck cancer include tobacco and heavy alcohol
use. Other non-modifiable risk factors include infection with
certain types of HPV, also called human papillomaviruses. Each
year, worldwide, there are approximately 400,000 cases of cancer of
the oral cavity and pharynx, in addition to approximately 160,000
cases of cancer of the larynx, resulting in approximately 300,000
deaths. In the U.S. approximately 62,000 new cases of cancer of the
oral cavity, pharynx and larynx are estimated to be diagnosed in
2016.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
Immune-mediated pneumonitis, including fatal cases, occurred in
patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2%) of
1,567 patients with melanoma, including Grade 1 (0.8%), 2 (0.8%),
and 3 (0.4%) pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550
patients with non-small cell lung cancer (NSCLC), including Grade 2
(1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis and more
frequently in patients with a history of asthma/chronic obstructive
pulmonary disease (5.4%) or prior thoracic radiation (6.0%).
Monitor patients for signs and symptoms of pneumonitis. Evaluate
suspected pneumonitis with radiographic imaging. Administer
corticosteroids for Grade 2 or greater pneumonitis. Withhold
KEYTRUDA (pembrolizumab) for Grade 2; permanently discontinue
KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
Immune-mediated colitis occurred in 31 (2%) of 1,567 patients
with melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%)
colitis. Immune-mediated colitis occurred in 4 (0.7%) of 550
patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis.
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.
Immune-mediated hepatitis occurred in 16 (1%) of 1,567 patients
with melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%)
hepatitis. 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 13 (0.8%) of 1,567 patients with
melanoma, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%)
hypophysitis. Hypophysitis occurred in 1 (0.2%) of 550 patients
with NSCLC, which was Grade 3 in severity. Monitor patients for
signs and symptoms of hypophysitis (including hypopituitarism and
adrenal insufficiency). Administer corticosteroids and hormone
replacement as clinically indicated. Withhold KEYTRUDA for Grade 2;
withhold or discontinue for Grade 3 or 4 hypophysitis.
Hyperthyroidism occurred in 51 (3.3%) of 1,567 patients with
melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism.
Hypothyroidism occurred in 127 (8.1%) of 1,567 patients with
melanoma, including Grade 3 (0.1%) hypothyroidism. Hyperthyroidism
occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2
(0.7%) or 3 (0.3%) hyperthyroidism. Hypothyroidism occurred in 38
(6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3
(0.2%) hypothyroidism. 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 replacement hormones for
hypothyroidism and manage hyperthyroidism with thionamides and
beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for
Grade 3 or 4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis,
occurred in 3 (0.1%) of 2,117 patients. Monitor patients for
hyperglycemia or other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA (pembrolizumab)
and administer anti-hyperglycemics in patients with severe
hyperglycemia.
Immune-mediated nephritis occurred in 7 (0.4%) of 1,567 patients
with melanoma, including Grade 2 (0.2%), 3 (0.2%) and Grade 4
(0.1%) nephritis. 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. 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 to Grade 1 or
less, initiate corticosteroid taper and continue to taper over at
least 1 month. Based on limited data from clinical studies in
patients whose immune-related adverse reactions could not be
controlled with corticosteroid use, administration of other
systemic immunosuppressants can be considered. Resume KEYTRUDA when
the immune-mediated adverse reaction remains at Grade 1 or less
following corticosteroid taper. Permanently discontinue KEYTRUDA
for any Grade 3 immune-mediated adverse reaction that recurs and
for any life-threatening immune-mediated adverse reaction.
The following clinically significant, immune-mediated adverse
reactions occurred in less than 1% (unless otherwise indicated) of
1567 patients with melanoma: arthritis (1.6%), exfoliative
dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma. The following clinically significant,
immune-mediated adverse reactions occurred in less than 1% of 550
patients with NSCLC: rash, vasculitis, hemolytic anemia, serum
sickness, and myasthenia gravis.
Severe and life-threatening infusion-related reactions have been
reported in 3 (0.1%) of 2,117 patients. Monitor patients for signs
and symptoms of infusion related reactions including rigors,
chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia,
and fever. For Grade 3 or 4 reactions, stop infusion and
permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA can 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.
In Trial 6, KEYTRUDA (pembrolizumab) was discontinued due to
adverse reactions in 9% of 555 patients with advanced melanoma;
adverse reactions leading to discontinuation in more than one
patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic
reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
21% of patients; the most common (≥1%) was diarrhea (2.5%). The
most common adverse reactions with KEYTRUDA vs. ipilimumab were
fatigue (28% vs. 28%), diarrhea (26% with KEYTRUDA), rash (24% vs.
23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates
are listed for ipilimumab only for those adverse reactions that
occurred at the same or lower rate than with KEYTRUDA.
In Trial 2, KEYTRUDA was discontinued due to adverse reactions
in 12% of 357 patients with advanced melanoma; the most common
(≥1%) were general physical health deterioration (1%), asthenia
(1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
14% of patients; the most common (≥1%) were dyspnea (1%), diarrhea
(1%), and maculo-papular rash (1%). The most common adverse
reactions with KEYTRUDA vs. chemotherapy were fatigue (43% with
KEYTRUDA), pruritus (28% vs. 8%), rash (24% vs. 8%), constipation
(22% vs. 20%), nausea (22% with KEYTRUDA), diarrhea (20% vs. 20%),
and decreased appetite (20% with KEYTRUDA). Corresponding incidence
rates are listed for chemotherapy only for those adverse reactions
that occurred at the same or lower rate than with KEYTRUDA.
KEYTRUDA was discontinued due to adverse reactions in 14% of 550
patients with NSCLC. Serious adverse reactions occurred in 38% of
patients. The most frequent serious adverse reactions reported in
2% or more of patients were pleural effusion, pneumonia, dyspnea,
pulmonary embolism, and pneumonitis. The most common adverse
reactions (reported in at least 20% of patients) were fatigue
(44%), decreased appetite (25%), cough (29%), and dyspnea
(23%).
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 and for 4 months
after the final dose.
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
For 125 years, Merck has been a global health care 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 health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, 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 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 2015
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
Patient Information/Medication Guide for KEYTRUDA
at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
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MerckMedia:Pamela Eisele, 267-305-3558An Phan,
908-255-6325orInvestors:Teri Loxam, 908-740-1986Justin Holko,
908-740-1879
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