First-Time Findings from KEYNOTE-164 and
KEYNOTE-158, to Be Presented at ASCO, Further Support the Utility
of MSI-H and dMMR as Predictive Biomarkers for Tumor-Agnostic
Treatment Approach with KEYTRUDA
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the first presentation of findings from
KEYNOTE-164 and KEYNOTE-158, two phase 2 studies evaluating
KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in
patients with advanced microsatellite instability-high (MSI-H) or
mismatch repair deficient (dMMR) solid tumors. The studies showed
overall response rates (ORR), regardless of histology, with ORR
between 28 percent (95% CI, 17-41) and 38 percent (95% CI, 27-49)
across patients with MSI-H/dMMR colorectal cancer (CRC) and other
advanced MSI-H/dMMR solid tumors, respectively. These findings will
be presented on Monday, June 5 at the 2017 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract
#3071).
“These important data build on the research to date showing
clinically meaningful responses with pembrolizumab (KEYTRUDA)
monotherapy across a wide range of tumors with MSI-H or dMMR status
in patients whose disease is locally advanced or metastatic,” said
Dr. Luis A. Diaz, Jr., head of the division of solid tumor
oncology, Memorial Sloan Kettering Cancer Center. “Moreover, these
data confirm the initial findings we made demonstrating the value
of MSI-H or dMMR tumor status as a predictive biomarker for
KEYTRUDA for these difficult-to-treat cancers.”
“These data exemplify our commitment to advancing the use of
biomarkers to help identify patients most likely to benefit from
KEYTRUDA,” said Dr. Roger Dansey, senior vice president and
therapeutic area head, oncology late-stage development, Merck
Research Laboratories.
The KEYTRUDA (pembrolizumab) clinical development program
includes more than 30 tumor types in more than 500 clinical trials,
including more than 300 trials that combine KEYTRUDA with other
cancer treatments. Merck’s immuno-oncology clinical development
program includes multiple registration-enabling studies
investigating KEYTRUDA as a monotherapy in MSI-H and dMMR
cancers.
Key Findings from KEYNOTE-164 and KEYNOTE-158 Studies
KEYNOTE-164 and KEYNOTE-158 are ongoing global, open-label,
non-randomized, multi-cohort, multi-center phase 2 studies
evaluating KEYTRUDA (200 mg every three weeks) in patients with
advanced MSI-H or dMMR solid tumors. KEYNOTE-164 is enrolling
patients with previously treated, unresectable locally advanced or
metastatic MSI-H or dMMR CRC who received two or more prior
therapies that included fluoropyrimidine, irinotecan, and
oxaliplatin. KEYNOTE-158 is enrolling patients with any advanced
MSI-H solid tumor, with the exception of CRC, who had received one
or more prior therapies. MSI-H or dMMR tumor status is determined
using local laboratory-developed, polymerase chain reaction (PCR)
tests for MSI-H status or immunohistochemistry (IHC) tests for
dMMR. Tumor response is assessed every nine weeks per Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent,
central, blinded radiographic review. The primary endpoint of the
studies is ORR; secondary endpoints include duration of response,
progression-free survival (PFS), overall survival (OS) and
safety.
Of the 61 patients with advanced CRC who were enrolled in
KEYNOTE-164 (as of Feb. 10, 2017), the ORR was 28 percent (n=17/61)
(95% CI, 17-41) – with zero complete responses and 17 partial
responses; fourteen had stable disease and 28 had progressive
disease – for an overall disease control rate of 51 percent
(n=31/61) (95% CI, 38-64). Median time to response was four months
(range: 2-10).
Of the 77 patients with any advanced solid tumor, excluding CRC
and with ≥27 weeks of follow-up, who were enrolled in KEYNOTE-158
(as of Jan. 27, 2017), the ORR was 38 percent (n=29/77) (95% CI,
27-49) – with two complete responses and 27 partial responses;
sixteen had stable disease and 24 had progressive disease – for an
overall disease control rate of 58 percent (n=45/77) (95% CI,
47-70). Median time to response was 2 months (range: 1-4).
For the PFS analysis, in patients with CRC the estimated 6-month
rate was 43 percent and the 12-month rate was 34 percent – with a
median PFS of 2.3 months (95% CI, 2.1-8.1); in patients with any
advanced solid tumor, excluding CRC, the estimated 6-month rate was
45 percent – with a median PFS of 4.3 months (95% CI, 3.1-not
reached). For the OS analysis, in patients with CRC the estimated
6-month rate was 87 percent and the 12-month rate was 72 percent –
with a median OS not yet reached; in patients with any advanced
solid tumor, excluding CRC, the estimated 6-month rate was 73
percent – with a median OS not yet reached (95% CI, 9.2-not
reached). Median follow-up was 13.2 months (range: 0-17) and 6.1
months (range: 1-12), respectively. At the time of analysis, median
duration of response had not been reached in either study (range:
2.9+-12.5+ and range: 2.4+-9.2+, respectively).
The safety profile of KEYTRUDA (pembrolizumab) was consistent
with that observed in previously reported studies. In patients with
CRC, the treatment-related adverse events observed to date (any
grade occurring in 10% or more of patients) were arthralgia (n=10),
nausea (n=9), diarrhea (n=8), asthenia (n=7), pruritus (n=7) and
fatigue (n=6); these included Grade 3-4 treatment-related fatigue
(n=2) and asthenia (n=1). Immune-mediated adverse events of Grade
3-4 were pancreatitis (n=3), hepatitis (n=1) and severe skin
toxicity (n=1). There were no treatment-related deaths.
In patients with any advanced solid tumor, excluding CRC, the
treatment-related adverse events observed to date (any grade
occurring in 10% or more of patients) were fatigue (n=8), pruritus
(n=7), asthenia (n=7), diarrhea (n=7), nausea (n=6) and arthralgia
(n=2); these include Grade 3-4 asthenia (n=1) and diarrhea (n=1).
Immune-mediated adverse events of Grade 3-4 toxicity were severe
skin toxicity (n=2), hyperthyroidism (n=1), pneumonitis (n=1),
fulminant type 1 diabetes mellitus (n=1) and Guillain-Barre
Syndrome (n=1). There was one death attributed to treatment-related
pneumonia by investigator.
About Microsatellite Instability and DNA Mismatch
Repair
Microsatellites are short repetitive sequences of DNA found
throughout the genome. Microsatellite instability – or MSI –
is caused by a deficiency in the cell’s ability to repair errors in
the DNA sequence (DNA mismatch repair) that occur during cell
division, leading to a characteristic change in microsatellite
repeats. MSI is detected indirectly by demonstrating absence
of expression of mismatch repair proteins by IHC, or more directly
by PCR-based amplification of specific microsatellite repeats.
MSI-H (microsatellite instability-high) is already an established
biomarker in certain types of cancer. Patients determined to have
mismatch repair deficiency (dMMR) are biologically the same
population as those with MSI-H status. MSI-H/dMMR occurs in a
variety of cancers across all stages.
About KEYTRUDA® (pembrolizumab)
Injection
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.
Studies of KEYTRUDA – from the largest immuno-oncology program
in the industry with more than 500 trials – include a wide variety
of cancers and treatment settings. The KEYTRUDA clinical program
seeks to understand factors that predict a patient’s likelihood of
benefiting from treatment with KEYTRUDA, including the exploration
of several different biomarkers across a broad range of tumors.
KEYTRUDA is administered as an intravenous infusion over 30
minutes every three weeks for the approved indications. KEYTRUDA
for injection is supplied in a 100 mg single-dose vial.
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 (pembrolizumab), 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.
Urothelial Carcinoma
KEYTRUDA (pembrolizumab) 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 pediatric patients 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.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
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 (pembrolizumab) 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 (pembrolizumab) 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.
KEYTRUDA can cause other clinically important immune-mediated
adverse reactions. These immune-mediated reactions may occur in any
organ system. 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%), exfoliative dermatitis, bullous
pemphigoid, rash (1.4%), uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma. In addition, myelitis and myocarditis
were reported in other clinical trials, including classical Hodgkin
lymphoma, 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 (pembrolizumab).
Immune-mediated complications, including fatal events, occurred
in patients who underwent allogeneic hematopoietic stem cell
transplantation (HSCT) after being treated with KEYTRUDA. Of 23
patients with cHL who proceeded to allogeneic HSCT after treatment
with KEYTRUDA on any trial, 6 patients (26%) developed
graft-versus-host-disease (GVHD), one of which was fatal, and 2
patients (9%) developed severe hepatic veno-occlusive disease (VOD)
after reduced-intensity conditioning, one of which was fatal. 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. These
complications may occur despite intervening therapy between PD-1
blockade and allogeneic HSCT. Follow patients closely for early
evidence of transplant-related complications such as hyperacute
GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile
syndrome, hepatic VOD, and other immune-mediated adverse reactions,
and intervene promptly.
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.
The most common adverse reactions (reported in ≥20% of patients)
were fatigue, pruritis, diarrhea, decreased appetite, rash,
pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and
nausea.
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 ages 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%).
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck,
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.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the fastest-growing
development programs in the industry. We are currently executing an
expansive research program that includes more than 500 clinical
trials evaluating our anti-PD-1 therapy across more than 30 tumor
types. We also continue to strengthen our immuno-oncology portfolio
through strategic acquisitions and are prioritizing the development
of several promising immunotherapeutic 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 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
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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
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
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The company undertakes no obligation to publicly update any
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future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
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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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