Findings to Be Presented at 2017 ASCO Annual
Meeting Also Include Updated Data Evaluating Duration of Response
in Previously Untreated (First-Line) Urothelial Carcinoma Patients
Ineligible for Cisplatin-Based Therapy
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced updated results from KEYNOTE-045 and
KEYNOTE-052, two studies investigating KEYTRUDA® (pembrolizumab),
the company’s anti-PD-1 therapy, in certain patients with locally
advanced or metastatic urothelial carcinoma, a type of bladder
cancer. These data – which include updated survival and biomarker
analyses – demonstrate the clinical benefit of KEYTRUDA as a
second-line therapy for patients post-platinum failure and as a
first-line treatment for patients ineligible for cisplatin-based
therapy. Specifically, in the second-line setting, KEYTRUDA
improved overall survival (OS) compared to chemotherapy – reducing
the risk of death by 30 percent (HR, 0.70 [95% CI, 0.57-0.86], p =
0.0004) – and, in the first-line setting, KEYTRUDA demonstrated an
overall response rate (ORR) of 29 percent (95% CI, 25-34). Findings
will be presented in two oral sessions at the 2017 American Society
of Clinical Oncology (ASCO) Annual Meeting in Chicago on Monday,
June 5, from 8:12 to 8:36 a.m. CDT (Location: Arie Crown Theater)
(Abstracts #4501 and #4502).
“Historically, there have been limited treatment options for
patients with advanced urothelial bladder cancer,” said Dean F.
Bajorin, M.D., medical oncologist at Memorial Sloan Kettering
Cancer Center. “For patients with this devastating disease, the
efficacy and safety profile we have observed with KEYTRUDA in these
treatment settings represent an important new option.”
“The updated data at ASCO in previously treated urothelial
cancer patients continue to support the overall survival benefit we
have observed in the second-line treatment setting and the response
rates demonstrated in cisplatin-ineligible patients,” said Dr.
Roger Dansey, senior vice president and therapeutic area head,
oncology late-stage development, Merck Research Laboratories.
“Beyond these two studies, we are studying KEYTRUDA in other
treatment settings and look forward to executing on our robust
clinical development program in bladder cancer."
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. Currently, Merck has the largest immuno-oncology
clinical development program in bladder cancer, with 29 trials
underway involving KEYTRUDA as monotherapy and in combination,
including four registration-enabling studies.
Data in Second-Line Post-Platinum Failure Patients,
KEYNOTE-045 (Abstract #4501)
KEYNOTE-045 is a multicenter, randomized, active-controlled,
phase 3 trial, investigating KEYTRUDA in 542 patients with locally
advanced or metastatic urothelial carcinoma with disease
progression on or after platinum-containing chemotherapy
(additional details on the trial design are provided below). Data
to be presented at ASCO are based on longer follow-up (median
follow-up of 18.5 months as of Jan. 18, 2017; range: 14.2-26.5),
which continues to show a superior OS advantage with KEYTRUDA
compared to chemotherapy in the second-line treatment of patients
with advanced urothelial carcinoma who have progressed during or
following platinum-containing chemotherapy, regardless of PD-L1
expression.
Analyses of the primary endpoints showed a 30 percent reduction
in the risk of death with KEYTRUDA (n=270) compared to chemotherapy
(n=272) (HR, 0.70 [95% CI, 0.57-0.86], p = 0.0004). The median OS
with KEYTRUDA was 10.3 months (95% CI, 8.0-12.3) versus 7.4 months
with chemotherapy (95% CI, 6.1-8.1). As previously reported, there
was no significant improvement in progression-free survival (PFS)
between arms (HR, 0.96 [95% CI, 0.79-1.16], p= 0.32). The median
PFS was 2.1 months (95% CI, 2.0-2.2) in the KEYTRUDA arm and 3.3
months (95% CI, 2.4-3.5) in the chemotherapy arm. The six-month,
12-month and 18-month PFS rates in the KEYTRUDA arm were 28.8
percent, 17.6 percent and 16.8 percent, respectively; the
six-month, 12-month and 18-month PFS rates in the chemotherapy arm
were 28.4 percent, 7.9 percent and 3.5 percent, respectively.
Analyses of the secondary endpoints showed a higher ORR with
KEYTRUDA compared to chemotherapy. In patients treated with
KEYTRUDA, the ORR was 21.1 percent – with a complete response rate
of 7.8 percent and a partial response rate of 13.3 percent. In
patients treated with chemotherapy, the ORR was 11.0 percent – with
a complete response rate of 2.9 percent and a partial response rate
of 8.1 percent. The median duration of response had not been
reached in the KEYTRUDA (pembrolizumab) arm (range: 1.6+-20.7+) and
was 4.4 months in the chemotherapy arm (range: 1.4+-20.3+).
The safety profile of KEYTRUDA was consistent with that observed
in previously reported studies. Grade 1-2 treatment-related adverse
events in the KEYTRUDA arm included anemia, asthenia, constipation,
decreased appetite, diarrhea, fatigue, nausea, peripheral
neuropathy, peripheral sensory neuropathy and pruritus. Grade 3-5
treatment-related adverse events in the KEYTRUDA arm included
anemia, asthenia, decreased neutrophils, diarrhea, fatigue, nausea
and pruritus. Grade 3-5 immune-mediated adverse events included
adrenal insufficiency, colitis, nephritis, pneumonitis and severe
skin reaction.
Data in First-Line Cisplatin-Ineligible Patients, KEYNOTE-052
(Abstract #4502)
KEYNOTE-052 is a multicenter, open-label, single-arm phase 2
trial, investigating KEYTRUDA in 370 patients with locally advanced
or metastatic urothelial carcinoma who were not eligible for
cisplatin-containing chemotherapy (additional details on the trial
design are provided below). Findings to be presented at ASCO, which
include the full study population and longer follow-up, show that
in the first-line treatment setting many patients with
cisplatin-ineligible advanced urothelial carcinoma treated with
KEYTRUDA continue to experience complete or partial responses.
In the full study population (n=370), the efficacy analysis
showed an ORR of 29 percent (95% CI, 25-34) – with a complete
response rate of seven percent (95% CI, 5-10) and a partial
response rate of 22 percent (95% CI, 18-27). At the time of
analysis, 67 percent of responses were ongoing – of which 82
percent had lasted six months or longer. The median duration of
response had not been reached at the time of analysis (95% CI, 12
months-not reached).
The study included a training set (the first 100 patients
enrolled), which was used to identify the CPS cut-point for PD-L1
expression, and a validation set (which includes all subsequent 270
evaluable patients) intended to validate the combined positive
score (CPS) cut-point. Of the 270 patients in the validation set,
in patients with PD-L1 expression of less than 10 percent (CPS
<10%), the ORR was 23 percent (95% CI, 17-29), with a complete
response rate of three percent (95% CI, 1-6) and a partial response
rate of 20 percent (95% CI, 15-27); in patients expressing PD-L1
equal to or greater than 10 percent (CPS ≥10%), the ORR was 51
percent (95% CI, 40-63), with a complete response rate of 18
percent (95% CI, 10-28) and a partial response rate of 34 percent
(95% CI, 24-45).
The safety profile of KEYTRUDA was consistent with that observed
in previously reported studies. The treatment-related adverse
events (any grade occurring in 5% or more of patients [n=370] in
descending order) were fatigue (18%), pruritus (17%), rash (12%),
decreased appetite (10%), hypothyroidism (10%), diarrhea (9%), and
nausea (8%). Grade 3-5 treatment-related adverse events observed
(occurring in 3 or more of patients) were fatigue (2%), colitis
(2%), muscle weakness (1%), alkaline phosphatase increase (1%),
diarrhea (1%), pneumonitis (1%), AST increase (1%), asthenia (1%),
hepatitis (1%), and ALT increase (1%). Grade 3-5 immune-mediated
adverse events included: adrenal insufficiency, colitis, dermatitis
bullous, diabetic ketoacidosis, hepatitis, myocarditis,
pneumonitis, thyroiditis, type 1 diabetes mellitus,
tubulointerstitial nephritis and rash.
About the KEYNOTE-045 and KEYNOTE-052 Studies
KEYNOTE-045 is a multicenter, randomized, active-controlled,
phase 3 trial, investigating KEYTRUDA (pembrolizumab) in 542
patients with locally advanced or metastatic urothelial carcinoma
with disease progression on or after platinum-containing
chemotherapy. Patients were randomized to receive either KEYTRUDA
200 mg every three weeks (n=270) or investigator’s choice of any of
the following chemotherapy regimens, all given intravenously, every
three weeks (n=272): paclitaxel 175 mg/m2 (n=84), docetaxel 75
mg/m2 (n=84), or vinflunine 320 mg/m2 (n=87). Treatment continued
until unacceptable toxicity or disease progression; patients
without disease progression could be treated for up to 24 months.
The primary endpoints were OS and PFS, as assessed by blinded
independent central review (BICR) per RECIST (Response Evaluation
Criteria in Solid Tumors) v1.1; additional efficacy outcome
measures included ORR, as assessed by BICR per RECIST 1.1, and
duration of response. Efficacy was assessed in all patients, as
well as in patients with PD-L1 expression – as determined by a CPS
of equal to or greater than 10 percent (CPS ≥10%) (KEYTRUDA arm:
n=74/270; chemotherapy arm; n=90/272).
KEYNOTE-052 is a multicenter, open-label, single-arm phase 2
trial, investigating KEYTRUDA in 370 patients with locally advanced
or metastatic urothelial carcinoma who were not eligible for
cisplatin-containing chemotherapy. Patients received KEYTRUDA at a
dose of 200 mg every three weeks until unacceptable toxicity or
disease progression; patients without disease progression could be
treated for up to 24 months. The study included a training set (the
first 100 patients enrolled), which was used to identify the CPS
cut-point for PD-L1 expression, and a validation set, which
includes all subsequent 270 evaluable patients and will be used to
validate the CPS cut-point. The primary endpoints include ORR in
all patients enrolled in the study (total study population) and in
patients with PD-L1 positive tumors (expression of one percent or
more); secondary endpoints include duration of response, PFS and
OS. Tumor response was measured according to RECIST v1.1 by central
imaging vendor review.
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
benefitting 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, 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 (pembrolizumab) 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 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
(pembrolizumab) 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 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 (pembrolizumab) 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.
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
(pembrolizumab) 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.
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 (pembrolizumab) 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-052, KEYTRUDA was discontinued due to adverse
reactions in 11% of 370 patients with locally advanced or
metastatic urothelial carcinoma. The most common adverse reactions
(in≥20% of patients) were fatigue (38%), musculoskeletal pain
(24%), decreased appetite (22%), constipation (21%), rash (21%),
and diarrhea (20%). Eighteen patients (5%) died from causes other
than disease progression. Five patients (1.4%) who were treated
with KEYTRUDA experienced sepsis which led to death, and 3 patients
(0.8%) experienced pneumonia which led to death. Adverse reactions
leading to interruption of KEYTRUDA occurred in 22% of patients;
the most common (≥1%) were liver enzyme increase, diarrhea, urinary
tract infection, acute kidney injury, fatigue, joint pain, and
pneumonia. Serious adverse reactions occurred in 42% of patients,
the most frequent (≥2%) of which were urinary tract infection,
hematuria, acute kidney injury, pneumonia, and urosepsis.
In KEYNOTE-045, KEYTRUDA was discontinued due to adverse
reactions in 8% of 266 patients with locally advanced or metastatic
urothelial carcinoma. The most common adverse reaction resulting in
permanent discontinuation of KEYTRUDA was pneumonitis (1.9%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
20% of patients; the most common (≥1%) were urinary tract infection
(1.5%), diarrhea (1.5%), and colitis (1.1%). The most common
adverse reactions (20%) in patients who received KEYTRUDA vs those
who received chemotherapy were fatigue (38% vs 56%),
musculoskeletal pain (32% vs 27%), pruritus (23% vs 6%), decreased
appetite (21% vs 21%), nausea (21% vs 29%), and rash (20% vs 13%).
Serious adverse reactions occurred in 39% of KEYTRUDA-treated
patients, the most frequent (≥2%) of which were urinary tract
infection, pneumonia, anemia, and pneumonitis.
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.
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
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diseases, emerging animal diseases, Alzheimer’s disease and
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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
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conditions; manufacturing difficulties or delays; financial
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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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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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