KEYTRUDA is the Only Anti-PD-1 Therapy
Approved in First-Line Treatment of Metastatic NSCLC; KEYTRUDA
Demonstrated Superior Progression-Free and Overall Survival
Compared to Chemotherapy in Patients Whose Tumors Expressed High
Levels of PD-L1
FDA Also Approves a Labeling Update for
KEYTRUDA for the Treatment of Patients with Metastatic NSCLC Whose
Tumors Express PD-L1 (TPS of One Percent or More) 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
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® (pembrolizumab), the company’s
anti-PD-1 (programmed death receptor-1) therapy, 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] of 50 percent or more) as determined by an FDA-approved
test, with no EGFR or ALK genomic tumor aberrations. With this new
indication, KEYTRUDA is now the only anti-PD-1 therapy to be
approved in the first-line treatment setting for these patients. In
addition, the FDA approved a labeling update to include data from
KEYNOTE-010 in the second-line or greater treatment setting for
patients with metastatic NSCLC whose tumors express PD-L1 (TPS of
one percent or more) 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. In metastatic NSCLC, KEYTRUDA is
approved for use 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.
Immune-mediated adverse reactions occurred with KEYTRUDA
including pneumonitis, colitis, hepatitis, endocrinopathies, and
nephritis. Based on the severity of the adverse reaction, KEYTRUDA
(pembrolizumab) should be withheld or discontinued and
corticosteroids administered when appropriate. KEYTRUDA can also
cause severe or life-threatening infusion-related reactions.
Monitor patients for signs and symptoms of infusion-related
reactions and 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 regarding
immune-mediated and infusion-related adverse reactions and use in
pregnancy, see “Selected Important Safety Information” below.
“KEYTRUDA improved survival, compared to traditional
chemotherapy, in patients with non-small cell lung cancer whose
tumors express high levels of PD-L1,” said Roger M. Perlmutter,
M.D., Ph.D., president, Merck Research Laboratories. “The approval
of KEYTRUDA for the first-line treatment of metastatic non-small
cell lung cancer has the potential to change the treatment
landscape for these patients.”
“With this new indication, KEYTRUDA can now be a first treatment
option instead of chemotherapy for patients with metastatic
non-small cell lung cancer whose tumors express high levels of
PD-L1,” said Roy S. Herbst, M.D., Ph.D., professor of medicine and
chief of medical oncology, Yale Cancer Center and Smilow Cancer
Hospital at Yale New Haven. “These data reaffirm the importance of
testing for PD-L1 expression in non-small cell lung cancer in order
to identify those patients who are most likely to benefit from
treatment with KEYTRUDA.”
Data Supporting First-Line Approval
The approval was based on data from KEYNOTE-024, a randomized,
open-label, phase 3 study evaluating KEYTRUDA monotherapy compared
to standard of care (SOC) platinum-containing chemotherapy for the
treatment of patients with both squamous (18%) and non-squamous
(82%) metastatic NSCLC. The study enrolled patients who had not
received prior systemic chemotherapy treatment for their metastatic
disease and whose tumors had high PD-L1 expression (TPS of 50
percent or more) and with no EGFR or ALK aberrations. The study
randomized 305 patients to receive KEYTRUDA (200 mg every three
weeks) or investigator-choice SOC platinum-based chemotherapy
(pemetrexed+carboplatin, pemetrexed+cisplatin,
gemcitabine+cisplatin, gemcitabine+carboplatin, or
paclitaxel+carboplatin). Pemetrexed maintenance therapy was
permitted for patients with non-squamous histologies. The primary
endpoint was progression-free survival (PFS); additional efficacy
outcome measures were overall survival (OS) and overall response
rate (ORR).
Based on an interim analysis demonstrating KEYTRUDA
(pembrolizumab) was superior compared to chemotherapy for both the
primary endpoint of PFS and the secondary endpoint of OS, the trial
was stopped early in June 2016 to give patients still on
chemotherapy the opportunity to receive KEYTRUDA.
Findings demonstrated that KEYTRUDA reduced the risk of
progression or death by 50 percent compared to chemotherapy (HR,
0.50 [95% CI, 0.37, 0.68]; p<0.001). Additionally, KEYTRUDA
resulted in a 40 percent reduction in the risk of death compared to
chemotherapy (HR, 0.60 [95% CI, 0.41, 0.89]; p=0.005).
Efficacy Results from KEYNOTE-024
Endpoint KEYTRUDA
200 mg every 3 weeks
(n=154)
Chemotherapy
(n=151)
PFS Number (%) of patients with
event 73 (47%) 116 (77%) Median in months (95% CI)
10.3 (6.7, NR) 6.0 (4.2, 6.2) Hazard ratio* (95% CI)
0.50 (0.37, 0.68) p-Value (stratified log-rank)
<0.001
OS Number (%) of
patients with event 44 (29%) 64 (42%) Median in
months (95% CI) NR
(NR, NR)
NR
(9.4, NR)
Hazard ratio* (95% CI) 0.60 (0.41, 0.89) p-Value (stratified
log-rank) 0.005†
Objective Response Rate
ORR % (95% CI) 45% (37, 53) 28%
(21, 36) Complete response % 4% 1% Partial response %
41% 27% p-Value (Miettenen-Nurminen) 0.001
Median duration of responsein months
(range)
NR(1.9+, 14.5+)
6.3(2.1+, 12.6+)
* Based on the stratified Cox proportional hazard model † P-value
is compared with 0.0118 of the allocated alpha for this interim
analysis NR = not reached
“The approval of KEYTRUDA in the first-line setting adds to the
momentum of progress that has been made to treat lung cancer,
particularly in the area of immunotherapy,” said Laurie Fenton
Ambrose, president and CEO, Lung Cancer Alliance. “Patients now
have an option beyond chemotherapy at initial diagnosis. This
approval reinforces the need for biomarker testing so care can be
personalized and most effective.”
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 for Grade 2 or 3;
permanently discontinue KEYTRUDA for Grade 4 colitis. See
additional “Selected Important Safety Information” below.
Data Supporting Second-Line Labeling Update
KEYNOTE-010 is a randomized, open-label, phase 2/3 trial
evaluating KEYTRUDA (2 mg/kg [n=344] or 10 mg/kg [n=346] every
three weeks) compared to SOC chemotherapy (docetaxel, 75 mg/m2
every three weeks [n=343]) in 1,033 patients with squamous (21%)
and non-squamous (70%) metastatic NSCLC with all levels of PD-L1
expression (TPS of one percent or more) who had progressed
following platinum-containing chemotherapy and, if appropriate,
targeted therapy for EGFR or ALK genomic tumor aberrations.
Additionally, results were reported in a subset of patients who had
high PD-L1 expression (TPS of 50 percent or more) in the KEYTRUDA 2
mg/kg (n=139), KEYTRUDA 10 mg/kg (n=151), and chemotherapy cohorts
(n=152). The primary endpoints were OS and PFS. Additional efficacy
measures included ORR and response duration.
KEYTRUDA demonstrated superior OS versus docetaxel in patients
with all levels of PD-L1 expression. Based on exploratory
analyses, higher OS was associated with higher PD-L1 expression
level.
Efficacy Results from KEYNOTE-010:
Subgroup of Patients with TPS of 50 Percent or More
Endpoint KEYTRUDA 2 mg/kg every
3 weeksn=139
KEYTRUDA 10 mg/kg every
3 weeksn=151
Docetaxel 75 mg/m2 every
3 weeksn=152
OS Deaths (%)
58 (42%) 60 (40%) 86 (57%) Median in months
(95% CI) 14.9 (10.4, NR) 17.3 (11.8, NR) 8.2
(6.4, 10.7) Hazard ratio* (95% CI) 0.54 (0.38, 0.77)
0.50 (0.36, 0.70) --- p-Value (stratified log-rank)
<0.001 <0.001 ---
PFS
Events (%) 89 (64%) 97
(64%) 118 (78%) Median in months (95% CI) 5.2 (4.0,
6.5) 5.2 (4.1, 8.1) 4.1 (3.6, 4.3) Hazard ratio* (95%
CI) 0.58 (0.43, 0.77) 0.59 (0.45, 0.78) ---
p-Value (stratified log-rank) <0.001 <0.001
---
Objective Response Rate
ORR† (95% CI) 30% (23, 39) 29%
(22, 37) 8% (4, 13) p-Value (Miettenen-Nurminen)
<0.001 <0.001 ---
Median duration of response inmonths
(range)
NR(0.7+, 16.8+) NR(2.1+, 17.8+) 8.1
(2.1+, 8.8+)
* Hazard ratio (KEYTRUDA compared to docetaxel) based on the
stratified Cox proportional hazard model † All responses were
partial responses NR = not reached
Efficacy Results from KEYNOTE-010: All
Randomized Patients with TPS of One Percent or More
Endpoint KEYTRUDA 2 mg/kg every
3 weeksn=344
KEYTRUDA 10 mg/kg every
3 weeksn=346
Docetaxel 75 mg/m2 every
3 weeksn=343
OS Deaths (%)
172 (50%) 156 (45%) 193 (56%) Median in months
(95% CI) 10.4 (9.4, 11.9) 12.7 (10.0, 17.3)
8.5 (7.5, 9.8) Hazard ratio* (95% CI) 0.71 (0.58, 0.88)
0.61 (0.49, 0.75) --- p-Value (stratified log-rank)
<0.001 <0.001 ---
PFS
Events (%) 266 (77%)
255 (74%) 257 (75%) Median in months (95% CI)
3.9 (3.1, 4.1) 4.0 (2.6, 4.3) 4.0 (3.1, 4.2) Hazard
ratio* (95% CI) 0.88 (0.73, 1.04) 0.79 (0.66, 0.94)
--- p-Value (stratified log-rank) 0.068 0.005
---
Objective Response Rate
ORR† (95% CI) 18% (14, 23) 19%
(15, 23) 9% (7, 13) p-Value (Miettenen-Nurminen)
<0.001 <0.001 ---
Median duration of response inmonths
(range)
NR(0.7+, 20.1+) NR(2.1+, 17.8+) 6.2
(1.4+, 8.8+)
* Hazard ratio (KEYTRUDA compared to docetaxel) based on the
stratified Cox proportional hazard model † All responses were
partial responses NR = not reached
In KEYNOTE-010, treatment was discontinued for adverse reactions
in eight percent of the 682 patients receiving KEYTRUDA
(pembrolizumab) across both doses. The most common adverse event
resulting in permanent discontinuation of KEYTRUDA was pneumonitis
(1.8%). Adverse reactions leading to interruption of KEYTRUDA
(pembrolizumab) occurred in 23% of patients; the most common (≥1%)
were diarrhea (1%), fatigue (1.3%), pneumonia (1%), liver enzyme
elevation (1.2%), decreased appetite (1.3%), and pneumonitis (1%).
The most frequent adverse reactions (reported in at least 10% of
KEYTRUDA patients and occurring at the same or higher incidence
than in the docetaxel arm) were decreased appetite (25% for
KEYTRUDA vs. 23% for docetaxel), dyspnea (23% vs. 20%), nausea (20%
vs. 18%), cough (19% vs. 14%), rash (17% vs. 8%), constipation (15%
vs. 12%), vomiting (13% vs. 10%), arthralgia (11% vs. 9%), back
pain (11% vs. 8%), and pruritus (11% vs. 3%). Other clinically
important adverse reactions occurring in patients receiving
KEYTRUDA were fatigue (25%), diarrhea (14%), asthenia (11%), and
pyrexia (11%).
PD-L1 Companion Diagnostic for Patients with Metastatic
NSCLC
The PD-L1 IHC 22C3 PharmDx™ kit made by Dako North America,
Inc., an Agilent Technologies Company, was approved in 2015 by the
FDA for use in detecting PD-L1, an immune-related biomarker
expressed on some tumor cells. The diagnostic is intended to aid in
identifying appropriate patients for treatment with KEYTRUDA,
including previously treated patients whose tumors have any level
of PD-L1 expression (TPS of one percent or more) and previously
untreated patients whose tumors have high levels of PD-L1
expression (TPS of 50 percent or more). Tumors with a TPS of less
than one percent are considered to have no PD-L1 expression.
About KEYTRUDA® (pembrolizumab)
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 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 use vial.
KEYTRUDA Indications and Dosing
Melanoma
KEYTRUDA is indicated for the treatment of patients with
unresectable or metastatic melanoma at a dose of 2 mg/kg every
three weeks until disease progression or unacceptable toxicity.
Lung Cancer
KEYTRUDA (pembrolizumab) is indicated for the first-line
treatment of patients with metastatic NSCLC whose tumors have high
PD-L1 expression (TPS ≥50%) as determined by an FDA-approved test,
with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA 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.
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.
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 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. 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.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab) (continued)
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 (pembrolizumab),
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 anti-hyperglycemics 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. 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.
KEYTRUDA can cause severe or life-threatening infusion-related
reactions 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.
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.
KEYTRUDA was discontinued due to adverse reactions in 8% of 682
patients with metastatic NSCLC. The most common adverse event
resulting in permanent discontinuation of KEYTRUDA was pneumonitis
(1.8%). Adverse reactions leading to interruption of KEYTRUDA
occurred in 23% of patients; the most common (≥1%) were diarrhea
(1%), fatigue (1.3%), pneumonia (1%), liver enzyme elevation
(1.2%), decreased appetite (1.3%), and pneumonitis (1%). The most
common adverse reactions (occurring in at least 20% of patients and
at a higher incidence than docetaxel) were decreased appetite (25%
vs. 23%), dyspnea (23% vs. 20%), and nausea (20% vs. 18%).
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.
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 360 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 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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