Data Include Overall Response Rate,
Progression-Free Survival and Overall Survival Findings from
Additional Five Months of Follow-Up in KEYNOTE-021
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced updated results from KEYNOTE-021, Cohort
G1, which studied KEYTRUDA® (pembrolizumab), the company’s
anti-PD-1 therapy, in combination with pemetrexed and carboplatin
(pem/carbo) in the first-line treatment of patients with advanced
nonsquamous non-small cell lung cancer (NSCLC), irrespective of
PD-L1 expression. Data – which are based on an additional five
months of follow-up – demonstrated continued benefit with KEYTRUDA
plus pem/carbo, including an overall response rate (ORR) of 56.7
percent compared to 30.2 percent with pem/carbo alone (95% CI,
8.9%-42.3%; P = 0.0016). Progression-free survival (PFS) was longer
in the KEYTRUDA combination group, with the median not reached (95%
CI, 8.5 months-not reached) compared to 8.9 months in the pem/carbo
group (95% CI, 6.2-10.3) (HR 0.50 [95% CI, 0.29-0.84, P = 0.0038]).
Though statistical significance was not met, an updated overall
survival (OS) analysis for the combination with KEYTRUDA plus
pem/carbo showed a trend towards improvement compared to patients
treated with pem/carbo alone (HR, 0.69 [95% CI, 0.36-1.31, P =
0.13]). The findings are being presented at the 2017 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago
(Abstract #9094).
“With an additional five months of follow-up, we are seeing
continued benefits in overall response rate and progression-free
survival with KEYTRUDA plus pemetrexed/carboplatin,” said Dr.
Vassiliki Papadimitrakopoulou, section chief thoracic medical
oncology, UT MD Anderson Cancer Center. “These data support the use
of this combination regimen for patients with nonsquamous
metastatic non-small cell lung cancer, irrespective of PD-L1
expression.”
Merck has one of the world’s most robust clinical development
programs in immuno-oncology. The program includes extensive
research in lung cancer with multiple registration-enabling studies
for KEYTRUDA (pembrolizumab) currently underway. The KEYTRUDA
clinical development program encompasses more than 30 tumor types
in more than 500 clinical trials, including more than 300 trials
that combine KEYTRUDA with other cancer treatments.
“A significant unmet need in lung cancer has existed for
decades, and we are now seeing that KEYTRUDA combined with
pemetrexed and carboplatin shows a continued benefit for patients
with metastatic nonsquamous non-small cell lung cancer in the
first-line treatment of this disease,” said Dr. Roger Dansey,
senior vice president and therapeutic area head, oncology
late-stage development, Merck Research Laboratories. “We are
encouraged by these additional data and look forward to continuing
to study this combination through our ongoing clinical research
program.”
KEYNOTE-021, Cohort G1: Data in First-Line Patients
Irrespective of PD-L1 Expression (Abstract #9094)
Cohort G1 of the multicenter, open-label, phase 1/2 multi-cohort
KEYNOTE-021 study evaluated the efficacy and safety of KEYTRUDA in
combination with pemetrexed and carboplatin (KEYTRUDA + pem/carbo
combination group) compared with pemetrexed and carboplatin
(pem/carbo group) in 123 patients with metastatic, nonsquamous,
EGFR- and ALK-negative NSCLC in the first-line treatment setting.
The KEYNOTE-021G1 trial was conducted in collaboration
with Eli Lilly and Company, the maker of pemetrexed. Patients
were randomized to receive KEYTRUDA + pem/carbo (n=60) or pem/carbo
alone (n=63). Patients in the KEYTRUDA + pem/carbo combination
group received KEYTRUDA (200 mg), pemetrexed (500 mg/m2) and
carboplatin (AUC 5 mg/mL/min) every three weeks for four cycles
followed by KEYTRUDA every three weeks. In the pem/carbo group,
patients received pemetrexed (500 mg/m2) and carboplatin (AUC 5
mg/mL/min) alone for four cycles. At the investigator’s discretion,
maintenance pemetrexed (500 mg/m2) every three weeks was permitted
in both treatment groups. The major efficacy outcome measure was
overall response rate (ORR) as assessed by blinded independent
central review (BICR) using Response Evaluation Criteria in Solid
Tumors (RECIST) version 1.1. Additional efficacy outcome measures
were PFS as assessed by BICR using RECIST 1.1, duration of response
and OS.
Data to be presented at ASCO include a median follow-up of 14.5
months (range: 0.8-24.0). In this analysis, the KEYTRUDA +
pem/carbo combination demonstrated improvement over pem/carbo alone
in response rate, duration of response and PFS. ORR was 56.7
percent in the KEYTRUDA + pem/carbo combination group compared to
30.2 percent in the pem/carbo group (95% CI, 8.9%-42.3%; P =
0.0016). The median duration of response had not been reached in
the KEYTRUDA + pem/carbo combination group (range: 1.4+ to 18.6+)
and was 16.2 months (range: 2.8 to 20.7+) in the pem/carbo
group.
Findings also included an analysis based on PD-L1 expression. In
patients whose tumors did not express PD-L1 (TPS of less than 1%),
ORR was 62 percent (95% CI, 38-82) with KEYTRUDA (pembrolizumab) +
pem/carbo compared to 13 percent (95% CI, 3-34) with pem/carbo
alone. In patients whose tumors expressed PD-L1 (TPS of 1% or
more), ORR was 54 percent (95% CI, 37-70) with KEYTRUDA+ pem/carbo
compared to 40 percent (95% CI, 25-57) with pem/carbo alone. Among
these patients, those with high levels of PD-L1 (TPS of 50% or
more) were most likely to respond, with an ORR of 80 percent (95%
CI, 56-94) with KEYTRUDA + pem/carbo compared to 41 percent (95%
CI, 18-67) with pem/carbo alone. In patients with lower levels of
PD-L1 expression (TPS of one to 49%), ORR was 26 percent (95% CI,
9-51) with KEYTRUDA + pem/carbo compared to 39 percent (95% CI,
20-61) with pem/carbo alone.
PFS was longer in the KEYTRUDA combination group, with the
median not reached (95% CI, 8.5 months-not reached) compared to 8.9
months in the pem/carbo group (95% CI, 6.2-10.3) (HR 0.50 [95% CI,
0.29-0.84, P = 0.0038]). At nine and 12 months, PFS was 63.2
percent and 56.4 percent, respectively, in the KEYTRUDA + pem/carbo
combination group compared to 48.1 percent and 33.9 percent in the
pem/carbo group.
Seventy-five percent (n=36/48) of patients in the pem/carbo
group received subsequent anti-PD-1 or PD-L1 therapy, including 22
who received KEYTRUDA as part of study crossover.
Though statistical significance was not met in an analysis of
OS, the KEYTRUDA + pem/carbo combination was associated with a 31
percent (HR, 0.69 [95% CI, 0.36-1.31, P = 0.13]) reduction in the
risk of death. Median OS was not reached in either group; at nine
and 12 months, the estimated OS rate was 84.6 percent and 76.0
percent, respectively, in the KEYTRUDA + pem/carbo combination
group compared to 82.3 percent and 69.3 percent in the pem/carbo
group.
The safety findings were consistent with what has been seen in
previous trials among patients treated with KEYTRUDA. Grade 3-5
treatment-related adverse events occurring in the KEYTRUDA +
pem/carbo group were anemia (11.9%), neutrophil count decreased
(6.8%), fatigue (3.4%), nausea (1.7%), rash (1.7%), vomiting
(1.7%), aspartate aminotransferase increased (1.7%) and alanine
aminotransferase increased (1.7%). The most common immune-mediated
adverse events of any grade in patients receiving KEYTRUDA +
pem/carbo were hypothyroidism (11.9%), hyperthyroidism (8.5%),
pneumonitis (6.8%), infusion reactions (3.4%), severe skin toxicity
(1.7%) and colitis (1.7%). There was one treatment-related death in
a patient receiving KEYTRUDA + pem/carbo and two in patients
receiving pem/carbo alone.
About Lung Cancer
Lung cancer, which forms in the tissues of the lungs, usually
within cells lining the air passages, is the leading cause of
cancer death worldwide. Each year, more people die of lung cancer
than die of colon, breast and prostate cancers combined. The two
main types of lung cancer are non-small cell and small cell. NSCLC
is the most common type of lung cancer, accounting for about 85
percent of all cases. The five-year survival rate for patients
suffering from highly advanced, metastatic (Stage IV) lung cancers
is estimated to be two percent.
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 (pembrolizumab).
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.
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 (pembrolizumab) 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 (pembrolizumab) 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.
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.
When KEYTRUDA was administered in combination with carboplatin
and pemetrexed (carbo/pem), KEYTRUDA was discontinued in 10% of 59
patients. The most common adverse reaction resulting in
discontinuation of KEYTRUDA (≥2%) was acute kidney injury (3.4%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
39% of patients; the most common (≥2%) were fatigue (8%),
neutrophil count decreased (8%), anemia (5%), dyspnea (3.4%), and
pneumonitis (3.4%). The most common adverse reactions (≥20%) with
KEYTRUDA compared to carbo/pem alone were fatigue (71% vs 50%),
nausea (68% vs 56%), constipation (51% vs 37%), rash (42% vs 21%),
vomiting (39% vs 27%), dyspnea (39% vs 21%), diarrhea (37% vs 23%),
decreased appetite (31% vs 23%), headache (31% vs 16%), cough (24%
vs 18%), dizziness (24% vs 16%), insomnia (24% vs 15%), pruritus
(24% vs 4.8%), peripheral edema (22% vs 18%), dysgeusia (20% vs
11%), alopecia (20% vs 3.2%), upper respiratory tract infection
(20% vs 3.2%), and arthralgia (15% vs 24%). This study was not
designed to demonstrate a statistically significant difference in
adverse reaction rates for KEYTRUDA as compared to carbo/pem alone
for any specified adverse reaction.
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
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, Facebook, Instagram, 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
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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 2016
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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