KEYTRUDA is the First Anti-PD-1 Therapy
Approved for Adult and Pediatric Patients with Refractory PMBCL or
Who Have Relapsed After Two or More Prior Lines of Therapy
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has approved KEYTRUDA®, the company’s anti-PD-1 therapy, for
the treatment of adult and pediatric patients with refractory
primary mediastinal large B-cell lymphoma (PMBCL), or who have
relapsed after two or more prior lines of therapy. This indication
is approved under the FDA’s accelerated approval regulations based
on tumor response rate and durability of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials.
KEYTRUDA is not recommended for the treatment of patients with
PMBCL who require urgent cytoreductive therapy. With this
indication, KEYTRUDA becomes the first anti-PD-1 therapy to be
approved for the treatment of PMBCL, a type of non-Hodgkin
lymphoma. This is the second indication for KEYTRUDA for the
treatment of a hematologic malignancy.
"Relapsed or refractory PMBCL is often a challenging disease to
treat, and many affected patients are young adults,” said Philippe
Armand, M.D., Ph.D., medical oncologist in the Hematologic Oncology
Treatment Center at Dana-Farber Cancer Institute. “In the clinical
trial that supported this approval, treatment with KEYTRUDA
resulted in meaningful responses, including complete disease
remission in some patients. This approval therefore provides
another therapeutic option for patients with PMBCL who have
progressed on or after prior therapies."
Immune-mediated adverse reactions occurred with KEYTRUDA,
including pneumonitis, colitis, hepatitis, endocrinopathies,
nephritis, severe skin reactions and solid organ transplant
rejection. Based on the severity of the adverse reaction, KEYTRUDA
should be withheld or discontinued and corticosteroids administered
if appropriate. Immune-mediated complications, including fatal
events, occurred in patients with classical Hodgkin lymphoma (cHL)
who underwent allogeneic hematopoietic stem cell transplantation
(HSCT) after treatment with KEYTRUDA. Follow patients closely for
early evidence of transplant-related complications, and intervene
promptly. In patients with a history of allogeneic HSCT, acute
graft-versus-host disease (GVHD), including fatal GVHD, has been
reported after treatment with KEYTRUDA; consider the benefit of
KEYTRUDA versus the risk of GVHD. KEYTRUDA can also cause severe or
life-threatening infusion-related reactions. Monitor patients for
signs and symptoms of infusion-related reactions; 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. Female patients of
reproductive potential should be advised of the potential hazard to
a fetus. For more information, see “Selected Important Safety
Information” below.
“The approval of our anti-PD-1 therapy, KEYTRUDA, for the
treatment of refractory or relapsed PMBCL provides an important
therapeutic option for patients who have this rare disease,” said
Jonathan Cheng, M.D., vice president, oncology clinical
research, Merck Research Laboratories. “This approval
reinforces Merck’s commitment to helping patients diagnosed with
hematologic cancers and marks the second indication for KEYTRUDA in
a hematologic malignancy.”
Data Supporting the Approval
The approval was based on data from KEYNOTE-170, a multicenter,
open-label, single-arm trial evaluating KEYTRUDA in 53 patients
with relapsed or refractory PMBCL. Patients were not eligible for
the trial if they had active non-infectious pneumonitis, allogeneic
HSCT within the past five years (or greater than 5 years but with
symptoms of GVHD), active autoimmune disease, a medical condition
that required immunosuppression, or an active infection requiring
systemic therapy. Patients received KEYTRUDA 200 mg every three
weeks until unacceptable toxicity or documented disease
progression, or for up to 24 months for patients who did not
progress. Disease assessments were performed every 12 weeks and
assessed by blinded independent central review according to the
2007 revised International Working Group criteria. Efficacy was
based on overall response rate (ORR) and duration of response
(DOR).
Among the 53 patients accrued in KEYNOTE-170, the baseline
characteristics were: median age of 33 years (range, 20 to 61
years); 43 percent were male; 92 percent were White; 43 percent had
an ECOG performance status (PS) of 0 and 57 percent had an ECOG PS
of 1. The median number of prior lines of therapy administered for
the treatment of PMBCL was three (range, 2 to 8). Thirty-six
percent had primary refractory disease, 49 percent had relapsed
disease refractory to the last prior therapy, and 15 percent had
untreated relapse. Twenty-six percent of patients had undergone
prior autologous HSCT and 32 percent of patients had prior
radiation therapy. All patients had received rituximab as part of a
prior line of therapy.
In KEYNOTE-170, the ORR was 45 percent (95% CI, 32, 60), with a
complete response rate (CRR) of 11 percent and a partial response
rate of 34 percent. Median DOR, based on 24 patients who responded,
was not reached (range, 1.1+ to 19.2+ months). For the 24
responders, the median time to first objective response (complete
or partial response) was 2.8 months (range, 2.1 to 8.5 months).
Median follow-up time was 9.7 months.
Among the 53 patients with PMBCL treated in KEYNOTE-170,
KEYTRUDA was discontinued due to adverse reactions in eight percent
of patients, and treatment was interrupted due to adverse reactions
in 15 percent. Twenty-five percent of patients had an adverse
reaction requiring systemic corticosteroid therapy. Serious adverse
reactions occurred in 26 percent of patients, and included
arrhythmia (4%), cardiac tamponade (2%), myocardial infarction
(2%), pericardial effusion (2%) and pericarditis (2%). Six (11%)
patients died within 30 days of start of treatment. The most common
adverse reactions (occurring in ≥20% of patients) were
musculoskeletal pain (30%), upper respiratory tract infection and
pyrexia (28% each), cough (26%), fatigue (23%) and dyspnea
(21%).
There is limited experience with KEYTRUDA in pediatric patients.
Efficacy for pediatric patients with PMBCL was extrapolated from
the results in the adult PMBCL population. In a study of 40
pediatric patients with advanced melanoma, lymphoma, or PD-L1
positive advanced, relapsed, or refractory solid tumors, patients
were administered KEYTRUDA 2 mg/kg every three weeks. Patients
received KEYTRUDA for a median of three doses (range, 1-17 doses),
with 34 patients (85%) receiving KEYTRUDA for two doses or more.
The safety profile in these pediatric patients was similar to that
seen in adults treated with KEYTRUDA. Toxicities that occurred at a
higher rate (≥15% difference) in pediatric patients when compared
to adults under 65 years of age were fatigue (45%), vomiting (38%),
abdominal pain (28%), hypertransaminasemia (28%) and hyponatremia
(18%).
About KEYTRUDA® (pembrolizumab) Injection, 100
mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the
ability of the body's immune system to help detect and fight tumor
cells. KEYTRUDA is a humanized monoclonal antibody that 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.
Merck has the industry's largest immuno-oncology clinical
research program, which currently involves more than 750 trials
studying KEYTRUDA across a wide variety of cancers and treatment
settings. The KEYTRUDA clinical program seeks to understand the
role of KEYTRUDA across cancers and the factors that may predict a
patient's likelihood of benefitting from treatment with KEYTRUDA,
including exploring several different biomarkers.
KEYTRUDA® (pembrolizumab) Indications and
Dosing
Melanoma
KEYTRUDA is indicated for the treatment of patients with
unresectable or metastatic melanoma at a fixed dose of 200 mg every
three weeks until disease progression or unacceptable toxicity.
Lung Cancer
KEYTRUDA, as a single agent, is indicated for the first-line
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors have high PD-L1 expression [tumor proportion
score (TPS) ≥50%] as determined by an FDA-approved test, with no
EGFR or ALK genomic tumor aberrations.
KEYTRUDA, as a single agent, is also indicated for the treatment
of patients with metastatic NSCLC whose tumors express PD-L1 (TPS
≥1%) 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.
KEYTRUDA, in combination with pemetrexed and carboplatin, is
indicated for the first-line treatment of patients with metastatic
nonsquamous NSCLC. This indication is approved under accelerated
approval based on tumor response rate and progression-free
survival. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials.
In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of
200 mg every three weeks until disease progression, unacceptable
toxicity, or up to 24 months in patients without disease
progression.
When administering KEYTRUDA in combination with chemotherapy,
KEYTRUDA should be administered prior to chemotherapy when given on
the same day. See also the Prescribing Information for pemetrexed
and carboplatin.
Head and Neck Cancer
KEYTRUDA is indicated 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. This indication is approved under accelerated
approval based on tumor response rate and durability of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the
confirmatory trials. In HNSCC, KEYTRUDA is administered at a fixed
dose of 200 mg every three weeks until disease progression,
unacceptable toxicity, or up to 24 months in patients without
disease progression.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric
patients with refractory classical Hodgkin lymphoma (cHL), or who
have relapsed after three or more prior lines of therapy. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials. In adults with cHL,
KEYTRUDA is administered at a fixed dose of 200 mg every three
weeks until disease progression or unacceptable toxicity, or up to
24 months in patients without disease progression. In pediatric
patients with cHL, KEYTRUDA is administered at a dose of 2 mg/kg
(up to a maximum of 200 mg) every three weeks until disease
progression or unacceptable toxicity, or up to 24 months in
patients without disease progression.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric
patients with refractory primary mediastinal large B-cell lymphoma
(PMBCL), or who have relapsed after 2 or more prior lines of
therapy. This indication is approved under accelerated approval
based on tumor response rate and durability of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials.
KEYTRUDA is not recommended for the treatment of patients with
PMBCL who require urgent cytoreductive therapy.
In adults with PMBCL, KEYTRUDA is administered at a fixed dose
of 200 mg every three weeks until disease progression, unacceptable
toxicity, or up to 24 months in patients without disease
progression. In pediatric patients with PMBCL, KEYTRUDA is
administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every
three weeks until disease progression or unacceptable toxicity, or
up to 24 months in patients without disease progression.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who are not eligible
for cisplatin-containing chemotherapy. This indication is approved
under accelerated approval based on tumor response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
KEYTRUDA is also indicated for the treatment of patients with
locally advanced or metastatic urothelial carcinoma who have
disease progression during or following platinum-containing
chemotherapy or within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy.
In locally advanced or metastatic urothelial carcinoma, KEYTRUDA
is administered at a fixed dose of 200 mg every three weeks until
disease progression or unacceptable toxicity, or up to 24 months in
patients without disease progression.
Microsatellite Instability-High (MSI-H) Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric
patients with unresectable or metastatic microsatellite
instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed
following prior treatment and who have no satisfactory alternative
treatment options, or
- colorectal cancer that has progressed
following treatment with fluoropyrimidine, oxaliplatin, and
irinotecan.
This indication is approved under accelerated approval based on
tumor response rate and durability of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in the confirmatory trials. The
safety and effectiveness of KEYTRUDA in pediatric patients with
MSI-H central nervous system cancers have not been established.
In adult patients with MSI-H cancer, KEYTRUDA is administered at
a fixed dose of 200 mg every three weeks until disease progression,
unacceptable toxicity, or up to 24 months in patients without
disease progression. In children with MSI-H cancer, KEYTRUDA is
administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every
three weeks until disease progression or unacceptable toxicity, or
up to 24 months in patients without disease progression.
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with
recurrent locally advanced or metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an
FDA-approved test, with disease progression on or after two or more
prior lines of therapy including fluoropyrimidine- and
platinum-containing chemotherapy and if appropriate,
HER2/neu-targeted therapy. This indication is approved under
accelerated approval based on tumor response rate and durability of
response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials. The recommended dose of KEYTRUDA is 200 mg
every three weeks until disease progression, unacceptable toxicity,
or up to 24 months in patients without disease progression.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with
recurrent or metastatic cervical cancer with disease progression on
or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as
determined by an FDA-approved test. This indication is approved
under accelerated approval based on tumor response rate and
durability of response. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in the confirmatory trials. The recommended dose of KEYTRUDA is 200
mg every three weeks until disease progression, unacceptable
toxicity or up to 24 months in patients without disease
progression.
Selected Important Safety Information for KEYTRUDA
KEYTRUDA can cause immune-mediated pneumonitis, including fatal
cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving
KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%),
and 5 (0.1%) pneumonitis, and occurred more frequently in patients
with a history of prior thoracic radiation (6.9%) compared to those
without (2.9%). 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 or recurrent Grade 2 pneumonitis.
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in
48 (1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.4%), 3 (1.1%), and 4 (<0.1%) 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.
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred
in 19 (0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.1%), 3 (0.4%), 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.
KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17
(0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.2%), 3 (0.3%), and 4 (<0.1%) hypophysitis. 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.
KEYTRUDA can cause thyroid disorders, including hyperthyroidism,
hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96
(3.4%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237
(8.5%) of 2799 patients receiving KEYTRUDA, including Grade 2
(6.2%) and 3 (0.1%) hypothyroidism. Thyroiditis occurred in 16
(0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.3%) thyroiditis. 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.
KEYTRUDA can cause type 1 diabetes mellitus, including diabetic
ketoacidosis, which have been reported in 6 (0.2%) of 2799
patients. Monitor patients for hyperglycemia or other signs and
symptoms of diabetes. Administer insulin for type 1 diabetes, and
withhold KEYTRUDA and administer antihyperglycemics in patients
with severe hyperglycemia.
KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred
in 9 (0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.1%), 3 (0.1%), and 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.
Immune-mediated rashes, including Stevens-Johnson syndrome
(SJS), toxic epidermal necrolysis (TEN) (some cases with fatal
outcome), exfoliative dermatitis, and bullous pemphigoid, can
occur. Monitor patients for suspected severe skin reactions and
based on the severity of the adverse reaction, withhold or
permanently discontinue KEYTRUDA and administer corticosteroids.
For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer
the patient for specialized care for assessment and treatment. If
SJS or TEN is confirmed, permanently discontinue KEYTRUDA.
Immune-mediated adverse reactions, which may be severe or fatal,
can occur in any organ system or tissue in patients receiving
KEYTRUDA. While immune-mediated adverse reactions usually occur
during treatment with PD-1/PD-L1 blocking antibodies, they may
occur after discontinuation of treatment. 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
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
2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, sarcoidosis, and encephalitis. In addition, myelitis and
myocarditis were reported in other clinical trials, including cHL,
and postmarketing use.
Solid organ transplant rejection has been reported in
postmarketing use of KEYTRUDA. Treatment with KEYTRUDA may increase
the risk of rejection in solid organ transplant recipients.
Consider the benefit of treatment with KEYTRUDA vs the risk of
possible organ rejection in these patients.
KEYTRUDA can cause severe or life-threatening infusion-related
reactions, including hypersensitivity and anaphylaxis, which have
been reported in 6 (0.2%) of 2799 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.
Immune-mediated complications, including fatal events, occurred
in patients who underwent allogeneic hematopoietic stem cell
transplantation (HSCT) after treatment with KEYTRUDA. Of 23
patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA,
6 developed graft-versus-host disease (GVHD) (one fatal case), and
2 developed severe hepatic veno-occlusive disease (VOD) after
reduced-intensity conditioning (one fatal case). Cases of fatal
hyperacute GVHD after allogeneic HSCT have also been reported in
patients with lymphoma who received a PD-1 receptor–blocking
antibody before transplantation. Follow patients closely for early
evidence of transplant-related complications such as hyperacute
GVHD, Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome,
hepatic VOD, and other immune-mediated adverse reactions, and
intervene promptly.
In patients with a history of allogeneic HSCT, acute GVHD,
including fatal GVHD, has been reported after treatment with
KEYTRUDA. Patients who experienced GVHD after their transplant
procedure may be at increased risk for GVHD after KEYTRUDA.
Consider the benefit of KEYTRUDA vs the risk of GVHD in these
patients.
In clinical trials in patients with multiple myeloma, the
addition of KEYTRUDA to a thalidomide analogue plus dexamethasone
resulted in increased mortality. Treatment of these patients with a
PD-1 or PD-L1 blocking antibody in this combination is not
recommended outside of controlled clinical trials.
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 KEYNOTE-170, KEYTRUDA was discontinued due to adverse
reactions in 8% of 53 patients with PMBCL, and treatment was
interrupted due to adverse reactions in 15%. Twenty-five percent
(25%) of patients had an adverse reaction requiring systemic
corticosteroid therapy. Serious adverse reactions occurred in 26%
of patients and included: arrhythmia (4%), cardiac tamponade (2%),
myocardial infarction (2%), pericardial effusion (2%), and
pericarditis (2%). Six (11%) patients died within 30 days of start
of treatment. The most common adverse reactions (occurring in ≥20%
of patients) were musculoskeletal pain (30%), upper respiratory
tract infection and pyrexia (28% each), cough (26%), fatigue (23%),
and dyspnea (21%).
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.
There is limited experience in pediatric patients. In a study,
40 pediatric patients (16 children aged 2 years to younger than 12
years and 24 adolescents aged 12 years to 18 years) with advanced
melanoma, lymphoma, or PD-L1–positive advanced, relapsed, or
refractory solid tumors were administered KEYTRUDA 2 mg/kg every 3
weeks. Patients received KEYTRUDA for a median of 3 doses (range
1–17 doses), with 34 patients (85%) receiving KEYTRUDA for 2 doses
or more. The safety profile in these pediatric patients was similar
to that seen in adults treated with KEYTRUDA. Toxicities that
occurred at a higher rate (≥15% difference) in these patients when
compared to adults under 65 years of age were fatigue (45%),
vomiting (38%), abdominal pain (28%), hypertransaminasemia (28%),
and hyponatremia (18%).
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck,
the potential to bring new hope to people with cancer drives our
purpose and supporting accessibility to our cancer medicines is our
commitment.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the largest
development programs in the industry across more than 30 tumor
types. We also continue to strengthen our portfolio through
strategic acquisitions and are prioritizing the development of
several promising oncology candidates with the potential to improve
the treatment of advanced cancers.
For more information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About the Merck Access Program for KEYTRUDA
At Merck, we are committed to supporting accessibility to our
cancer medicines. Merck provides multiple programs to help ensure
that appropriate patients who are prescribed KEYTRUDA have access
to our anti-PD-1 therapy. The Merck Access Program provides
reimbursement support for patients receiving KEYTRUDA, including
information to help with out-of-pocket costs and co-pay assistance
for eligible patients. Merck also offers free product through our
patient assistance program to eligible patients, primarily the
uninsured, who, without our assistance, could not afford their
medicine. More information is available by calling 855-257-3932 or
visiting www.merckaccessprogram-keytruda.com.
About Merck’s Patient Support Program for KEYTRUDA
Merck is committed to helping provide patients and their
caregivers support throughout their treatment with KEYTRUDA. The
KEY+YOU Patient Support Program provides a range of resources and
services. For further information and to sign up, patients and
physicians may call 85-KEYTRUDA (855-398-7832) or visit
www.keytruda.com.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
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. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola.
For more information,
visit www.merck.com and connect with us on Twitter,
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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
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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
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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
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The company undertakes no obligation to publicly update any
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results to differ materially from those described in the
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Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA 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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