What can we help you find?

October 24, 2016 5:04 pm ET

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 response in 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 weeks n=139		KEYTRUDA 10 mg/kg every 3 weeks n=151		Docetaxel 75 mg/m 2 every 3 weeks n=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 in months (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 weeks n=344		KEYTRUDA 10 mg/kg every 3 weeks n=346		Docetaxel 75 mg/m 2 every 3 weeks n=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 in months (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

.

Merck
Media:
Pamela Eisele, 267-305-3558
Courtney Ronaldo, 908-236-1108
or
Investors:
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898