Longer Term Follow-Up Data with Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Carboplatin in First-Line Nonsquamous Metastatic Non-Small Cell Lung Cancer (NSCLC) to Be Presented at 2017 ASCO Annual Meeting

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June 3, 2017 7:00 am ET

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 TwitterFacebookInstagram,
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and LinkedIn.

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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
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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
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and other protections for innovative products; and the exposure to
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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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