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September 5, 2017 5:30 am ET

Now Approved for Adults Previously Treated with Platinum-Containing Chemotherapy and for Adults Ineligible for Cisplatin-Containing Chemotherapy

Only Anti-PD-1 Therapy to Demonstrate Superior Overall Survival Versus Chemotherapy in Patients with Advanced Urothelial Carcinoma Post-Platinum Failure

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that the European Commission has approved KEYTRUDA^®
(pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of
certain patients with locally advanced or metastatic urothelial
carcinoma, a type of bladder cancer. Specifically, KEYTRUDA is approved
for use as monotherapy for the treatment of locally advanced or
metastatic urothelial carcinoma in adults who have received prior
platinum-containing chemotherapy, as well as adults who are not eligible
for cisplatin-containing chemotherapy.

The approval in patients previously treated with platinum-containing
chemotherapy was based on superior overall survival (OS) for KEYTRUDA
versus investigator-choice chemotherapy (paclitaxel, docetaxel,
vinflunine) (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002), as demonstrated in
the randomized, phase 3 KEYNOTE-045 trial. The approval in patients
ineligible for cisplatin-containing chemotherapy was based on phase 2
data from the KEYNOTE-052 trial, which demonstrated an overall response
rate (ORR) of 29 percent (95% CI, 25-34). The approval allows for the
marketing of KEYTRUDA in these two new indications in all 28 EU member
states plus Iceland, Lichtenstein and Norway at a dose of 200 mg every
three weeks until disease progression or unacceptable toxicity.

“This approval of KEYTRUDA is important for patients with advanced
urothelial carcinoma,” said Dr. Roger Dansey, senior vice president and
therapeutic area head, oncology late-stage development, Merck Research
Laboratories. “Our focus is now on working with health authorities in
Europe to ensure access for these patients as quickly as possible.”

“Despite advances, there remain limited treatment options available to
patients with locally advanced or metastatic urothelial carcinoma who
are either not eligible to receive cisplatin-containing chemotherapy –
which is platinum-based and currently the standard of care – or for
those patients whose cancer returns after receiving prior
platinum-containing chemotherapy,” said professor Ronald de Wit, M.D.,
Ph.D., group leader experimental systemic therapy of urogenital cancers,
Erasmus MC Cancer Institute. “It is exciting that with this approval
of KEYTRUDA, we now also have a new treatment option for patients
previously treated with platinum-containing chemotherapy that has shown
a clinically meaningful and improved overall survival benefit versus
chemotherapy in this difficult-to-treat population.”

Results in Patients Previously Treated with Platinum-Containing
Chemotherapy (KEYNOTE-045)

The approval in patients previously treated with platinum-containing
chemotherapy is based on data from a multicenter, randomized, controlled
trial, KEYNOTE-045, investigating KEYTRUDA (pembrolizumab) in patients
with locally advanced or metastatic urothelial carcinoma with disease
progression on or after platinum-containing chemotherapy. Patients must
have received a first-line platinum-containing regimen for locally
advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with
recurrence/progression ≤12 months following completion of therapy.
Patients were randomized (1:1) 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, docetaxel 75 mg/m²,
or vinflunine 320 mg/m². Patients were treated with KEYTRUDA
until unacceptable toxicity or disease progression, or for up to 24
months in patients without disease progression. The study excluded
patients with autoimmune disease, a medical condition that required
immunosuppression and patients with more than two prior lines of
systemic chemotherapy for metastatic urothelial cancer. The primary
efficacy outcomes were OS and progression-free survival (PFS) (as
assessed by BICR using RECIST v1.1); secondary outcome measures were ORR
(as assessed by BICR using RECIST v1.1) and duration of response.

In the study, KEYTRUDA demonstrated a statistically significant
improvement in OS compared to chemotherapy. Findings demonstrated that
KEYTRUDA resulted in a 27 percent reduction in the risk of death
compared to chemotherapy – with 155 events (57%) observed in the
KEYTRUDA arm, compared to 179 events (66%) in the chemotherapy arm (HR,
0.73 [95% CI: 0.59, 0.91], p=0.002); the median OS was 10.3 months (95%
CI: 8.0, 11.8) in the KEYTRUDA (pembrolizumab) arm, compared to 7.4
months (95% CI: 6.1, 8.3) in the chemotherapy arm.

There was no statistically significant difference between KEYTRUDA and
chemotherapy with respect to PFS. There were 218 events (81%) observed
in the KEYTRUDA arm, compared to 219 events (81%) in the chemotherapy
arm (HR, 0.98 [95% CI: 0.81, 1.19], p=0.416). The median PFS was 2.1
months (95% CI: 2.0, 2.2) in the KEYTRUDA arm, compared to 3.3 months
(95% CI: 2.3, 3.5) in the chemotherapy arm.

The ORR was 21 percent (95% CI: 16, 27) for patients receiving KEYTRUDA,
with a complete response rate of 7 percent and a partial response rate
of 14 percent. In the chemotherapy arm, the ORR was 11 percent (95% CI:
8, 16), with a complete response rate of 3 percent and a partial
response rate of 8 percent (p=0.001). The median duration of response
for patients treated with KEYTRUDA had not yet been reached (range: 1.6+
to 15.6+ months), compared to 4.3 months (range: 1.4+ to 15.4+ months)
in the chemotherapy arm.

Results in Patients Ineligible for Cisplatin-Containing Chemotherapy
(KEYNOTE-052)

The approval in patients ineligible for cisplatin-containing
chemotherapy is based on data from a multicenter, open-label study,
KEYNOTE-052, 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, or for up to 24 months in patients without disease
progression. The study excluded patients with autoimmune disease or a
medical condition that required immunosuppression. The primary efficacy
outcome measure was ORR as assessed by BICR using RECIST 1.1; secondary
efficacy outcome measures were duration of response, PFS, and OS.

The efficacy analysis, with a median follow-up time of 9.5 months,
showed an ORR of 29 percent (95% CI: 25, 34), a complete response rate
of 7 percent, and a partial response rate of 22 percent. The median
duration of response had not been reached (range: 1.4+ to 19.6+ months).

Safety Analysis

The safety analysis supporting the European approval of KEYTRUDA was
based on 3,830 patients with advanced melanoma, non-small cell lung
cancer (NSCLC), classical Hodgkin lymphoma (cHL) or urothelial carcinoma
across four doses (2 mg/kg every three weeks, 200 mg every three weeks,
or 10 mg/kg every two or three weeks) in clinical studies. In this
patient population, the most common adverse reactions (>10%) with
KEYTRUDA (pembrolizumab) were fatigue (21%), pruritus (16%), rash (13%),
diarrhea (12%) and nausea (10%). The majority of adverse reactions
reported were of Grade 1 or 2 severity. The most serious adverse
reactions were immune-related adverse reactions and severe
infusion-related reactions.

About Bladder Cancer

Bladder cancer begins when cells in the urinary bladder start to grow
uncontrollably. As more cancer cells develop, they can form a tumor and
spread to other areas of the body. Urothelial carcinoma, the most common
type of bladder cancer, starts in the urothelial cells that line the
inside of the bladder. In 2012, approximately 430,000 people worldwide
were diagnosed with bladder cancer and 165,000 died from the disease.
The incidence of bladder cancer is elevated in North America, Europe,
North Africa, the Middle East, Australia and New Zealand.
Cisplatin-based chemotherapy has long been the standard of care for the
first-line treatment of advanced bladder cancer; however, around half of
patients are not eligible to receive this type of treatment.

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 550 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 in the U.S.

KEYTRUDA (pembrolizumab) Indications and Dosing in the U.S.

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 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
(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.

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 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 (pembrolizumab) 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 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 (pembrolizumab).

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.

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic
epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative
dermatitis, and bullous pemphigoid can occur. Monitor patients for
suspected severe skin reactions and based on the severity of the adverse
reaction, withhold or permanently discontinue KEYTRUDA and administer
corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA
and refer the patient for specialized care for assessment and treatment.
If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

KEYTRUDA (pembrolizumab) 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%), 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 550 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

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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
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Risks and uncertainties include but are not limited to, general industry
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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
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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
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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

.

Merck
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