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May 10, 2017 4:39 pm ET

First Approval for an Anti-PD-1 Therapy as a Combination in Metastatic Nonsquamous NSCLC

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
therapy, in combination with pemetrexed (brand name Alimta^®)
and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for
the first-line treatment of metastatic nonsquamous NSCLC, irrespective
of PD-L1 expression. Under the FDA’s accelerated approval regulations,
this indication is approved based on tumor response rate and
progression-free survival (PFS). Continued approval for this indication
may be contingent upon verification and description of clinical benefit
in the confirmatory trials.

The approval was based on data from KEYNOTE-021, Cohort G1, in 123
previously untreated patients with metastatic nonsquamous NSCLC with no
EGFR or ALK genomic tumor aberrations and irrespective of PD-L1
expression. In this trial, KEYTRUDA + pem/carbo demonstrated an
objective response rate (ORR) that was nearly double the ORR of
pem/carbo alone (55 percent [95% CI: 42, 68] compared to 29 percent [95%
CI: 18, 41], respectively; all responses were partial responses). Among
patients who received KEYTRUDA + pem/carbo, 93 percent had a duration of
response of six months or more (range 1.4+ to 13.0+ months) compared to
81 percent who received pem/carbo alone (range 1.4+ to 15.2+ months). In
addition, findings demonstrated an improvement in PFS (HR 0.53 [95% CI,
0.31-0.91; p=0.0205]), with a median PFS of 13.0 months (95% CI, 8.3-not
estimable) for patients treated with KEYTRUDA + pem/carbo compared to
8.9 months (95% CI, 4.4-10.3) with pem/carbo alone.

Immune-mediated adverse reactions occurred with KEYTRUDA including
pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based
on the severity of the adverse reaction, KEYTRUDA 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;
for Grade 3 or 4 reactions, stop infusion and permanently discontinue
KEYTRUDA (pembrolizumab). 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.

“The improved responses seen with the KEYTRUDA plus
pemetrexed/carboplatin regimen are significant, and highlight the
importance of finding new approaches that address the unmet needs of
patients with metastatic nonsquamous non-small cell lung cancer,” said
Dr. Roger M. Perlmutter, president, Merck Research Laboratories.
“Today’s approval further supports our commitment to improve the lives
of people with cancer.”

“This approval marks an important milestone in the treatment of lung
cancer. Now, pembrolizumab in combination with pemetrexed and
carboplatin can be prescribed in the first-line setting for patients
with metastatic nonsquamous non-small cell lung cancer, irrespective of
PD-L1 expression,” said Dr. Corey Langer, director of thoracic oncology
and professor of medicine at the Hospital of the University of
Pennsylvania. “Physicians should continue to use each patient’s
individual characteristics – including biomarker status, histology, and
other clinical factors – to determine the best treatment plan for each
person.”

The combination therapy indication makes KEYTRUDA an option for more
patients. KEYTRUDA is the only anti-PD-1 approved in the first-line
setting as both monotherapy and combination therapy for appropriate
patients with metastatic NSCLC. KEYTRUDA is approved as monotherapy in
the first-line setting for patients with metastatic 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 monotherapy is also indicated for the
second-line or greater 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.

“The combination of this immunotherapy with pemetrexed and carboplatin
is more good news for patients,” said Bonnie J. Addario, a lung cancer
survivor and founder of the Bonnie J. Addario Lung Cancer Foundation.
“Congratulations to Merck and the FDA for moving so swiftly on this
important addition to our patients’ options for treatment. With this
approval, hope for lung cancer patients continues to improve.”

Data Supporting the Approval

The efficacy of KEYTRUDA (pembrolizumab) was investigated in patients
enrolled in the open-label, multicenter, multi-cohort KEYNOTE-021 study;
the efficacy data are limited to patients with metastatic nonsquamous
NSCLC randomized within the single cohort (Cohort G1). The KEYNOTE-021G1
trial was conducted in collaboration with Eli Lilly and Company, the
maker of pemetrexed. The key eligibility criteria for this cohort were
locally advanced or metastatic nonsquamous NSCLC, regardless of tumor
PD-L1 expression status, and no prior systemic treatment for metastatic
disease. Patients with autoimmune disease that required systemic therapy
within two years of treatment; a medical condition that required
immunosuppression; or who had received more than 30 Gy of thoracic
radiation within the prior 26 weeks were ineligible. Patients in
KEYNOTE-021G1 were randomized to receive KEYTRUDA + pem/carbo (n=60) or
pem/carbo alone (n=63). Patients in the KEYTRUDA combination arm
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 control arm, 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 arms. Treatment with KEYTRUDA continued until Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined progression of
disease as determined by blinded independent central review (BICR),
unacceptable toxicity, or a maximum of 24 months. Administration of
KEYTRUDA was permitted beyond RECIST-defined disease progression if the
patient was clinically stable and deriving clinical benefit as
determined by the investigator.

The major efficacy outcome measure was ORR as assessed by BICR using
RECIST 1.1. Additional efficacy outcome measures were PFS as assessed by
BICR using RECIST 1.1, duration of response, and overall survival (OS).

Findings from this cohort demonstrated an ORR with KEYTRUDA + pem/carbo
of 55 percent (95% CI: 42, 68) compared to 29 percent (95% CI: 18, 41)
for pem/carbo alone. KEYTRUDA in this combination also reduced the risk
of disease progression or death by 47 percent (HR, 0.53 [95% CI, 0.31,
0.91]; p=0.0205).

Exploratory analyses found similar results in patients with or without
PD-L1 expression, with an ORR in patients whose tumors did not express
PD-L1 (TPS <1%) of 57 percent with KEYTRUDA + pem/carbo compared to 13.0
percent with pem/carbo alone; in patients with PD-L1 TPS ≥1%, the ORR
was 54 percent with KEYTRUDA + pem/carbo compared to 38 percent with
pem/carbo alone.

Efficacy Results from KEYNOTE-021, Cohort G1

Endpoint				KEYTRUDA + Pem/Carbo (n=60)				Pem/Carbo (n=63)
Overall Response Rate
Overall Response Rate				55%				29%
(95% CI)				(42, 68)				(18, 41)
Complete Response				0%				0%
Partial Response				55%				29%
p-value*				0.0032
Duration of Response
% with duration ≥6-months†				93%				81%
Range (months)				1.4+ to 13.0+				1.4+ to 15.2+
PFS
Number of events (%)				23 (38%)				33 (52%)
Progressive Disease				15 (25%)				27 (43%)
Death				8 (13%)				6 (10%)
Median in months (95% CI)				13.0 (8.3, NE)				8.9 (4.4, 10.3)
Hazard ratio‡ (95% CI)				0.53 (0.31, 0.91)
p-value§				0.0205

*		Based on Miettinen-Nurminen method stratified by PD-L1 status (TPS < 1% vs. TPS ≥ 1%)
†		Based on Kaplan-Meier estimation
‡		Based on the Cox proportional hazard model stratified by PD-L1 status (TPS < 1% vs. TPS ≥ 1%)
§		Based on the log-rank test stratified by PD-L1 status (TPS < 1% vs. TPS ≥ 1%)
NE = not estimable

In the KEYNOTE-021G1 trial, safety was evaluated in 59 patients who
received KEYTRUDA (pembrolizumab) + pem/carbo and 62 patients who
received pem/carbo alone. KEYNOTE-021 was not designed to demonstrate a
statistically significant difference in adverse reaction rates for
KEYTRUDA plus chemotherapy, as compared to chemotherapy alone, for any
specified adverse reaction listed in the chart below.

KEYTRUDA was discontinued for adverse reactions in 10 percent of
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%).

Adverse Reactions Occurring in ≥20% of Patients in KEYNOTE-021, Cohort G1

			KEYTRUDA + Pem/Carbo n=59						Pem/Carbo n=62
Adverse Reaction			All Grades* (%)			Grade 3-4 (%)			All Grades (%)			Grade 3-4 (%)
General Disorders and Administration Site Conditions
Fatigue			71			3.4			50			0
Peripheral Edema			22			0			18			0
Gastrointestinal Disorders
Nausea			68			1.7			56			0
Constipation			51			0			37			1.6
Vomiting			39			1.7			27			0
Diarrhea			37			1.7			23			1.6
Skin and Subcutaneous Tissue Disorders
Rash†			42			1.7			21			1.6
Pruritus			24			0			4.8			0
Alopecia			20			0			3.2			0
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea			39			3.4			21			0
Cough			24			0			18			0
Metabolism and Nutrition Disorders
Decreased Appetite			31			0			23			0
Nervous System Disorders
Headache			31			0			16			1.6
Dizziness			24			0			16			0
Dysgeusia			20			0			11			0
Psychiatric Disorders
Insomnia			24			0			15			0
Infections and Infestations
Upper respiratory tract infection			20			0			3.2			0
Musculoskeletal and Connective Tissue Disorders
Arthralgia			15			0			24			1.6

*		Graded per NCI CTCAE v4.0
†		Includes rash, rash generalized, rash macular, rash maculo-papular, and rash pruritic.

When administering KEYTRUDA in combination with pem/carbo, KEYTRUDA
should be administered first prior to chemotherapy when given on the
same day. In metastatic NSCLC, KEYTRUDA is approved at a fixed dose of
200 mg administered as an intravenous infusion over 30 minutes every
three weeks until disease progression, unacceptable toxicity, or up to
24 months in patients without disease progression; pemetrexed and
carboplatin should be administered according to their FDA-approved
labels.

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 450 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

^®

(pembrolizumab) 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, 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 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 (pembrolizumab) 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.

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.

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 (pembrolizumab) 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.

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. 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 (pembrolizumab). Treatment with KEYTRUDA may increase the
risk of rejection in solid organ transplant recipients. Consider 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, 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 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 monotherapy 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
with docetaxel) were decreased appetite (25% vs 23%), dyspnea (23% vs
20%), and nausea (20% vs 18%).

When KEYTRUDA (pembrolizumab) was administered in combination with
pemetrexed and carboplatin, 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%). The study was not designed to
demonstrate a statistically significant difference in adverse reaction
rates for KEYTRUDA plus chemotherapy, as compared to chemotherapy 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 450 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 Access Program for KEYTRUDA

At Merck, we are committed to supporting accessibility to our cancer
medicines. Merck provides multiple programs to help ensure that
appropriate patients who are prescribed KEYTRUDA (pembrolizumab) have
access to our anti-PD-1 therapy. The Merck Access Program provides
reimbursement support for patients receiving KEYTRUDA, including
information to help with out-of-pocket costs and co-pay assistance for
eligible patients. Merck also offers free product through our patient
assistance program to eligible patients, primarily the uninsured, who,
without our assistance, could not afford their medicine. More
information is available by calling 1-855-257-3932 or visiting www.merckaccessprogram-keytruda.com.

About Merck’s Patient Support Program for KEYTRUDA

Merck is committed to helping provide patients and their caregivers
support throughout their treatment with KEYTRUDA. The KEY+YOU Patient
Support Program provides a range of resources and services. For further
information and to sign up, patients and physicians may call 85-KEYTRUDA
(855-398-7832) or visit www.keytruda.com.

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
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,
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and LinkedIn.

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“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
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respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
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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

.

Alimta^® is a registered trademark of Eli Lilly and Company.

Merck
Media:
Pamela Eisele, 267-305-3558
or
Investors:
Teri Loxam, 908-740-1986