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April 6, 2016 7:00 am ET

Data Evaluating KEYTRUDA as a Single Agent and in Novel Combinations Across a Wide Range of Cancers to Be Presented

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that new research investigating the use of KEYTRUDA^®
(pembrolizumab), the company’s anti-PD-1 therapy, in multiple tumor
types, both as a single agent and in combination with other therapies,
will be presented at this year’s American Association for Cancer
Research (AACR) Annual Meeting in New Orleans, April 16 – 20.

“The data being presented at AACR reinforce our commitment to studying
KEYTRUDA in a broad array of tumors and in a range of settings in order
to fully understand its potential to improve long-term disease control
and survival for people with cancer,” said Dr. Eric Rubin, vice
president and therapeutic area head, oncology early-stage development,
Merck Research Laboratories. “As a leader in immuno-oncology, Merck
continues to accelerate and further expand our clinical development
program – with a goal to provide clinicians with data to understand the
role of KEYTRUDA in a range of cancers.”

The KEYTRUDA clinical research program currently includes more than 250
clinical trials in more than 30 tumor types, including more than 100
trials that combine KEYTRUDA with other cancer treatments. More than 30
registration-enabling trials evaluating KEYTRUDA as a single agent and
in combination with other therapies are currently enrolling patients
with bladder cancer, breast cancer, colorectal cancer, esophageal
cancer, gastric cancer, head and neck cancer, Hodgkin lymphoma,
melanoma, multiple myeloma, non-small cell lung cancer (NSCLC), and
other tumors, with further trials in planning for other cancers. Several
of the trials are being sponsored by the National Cancer Institute (NCI)
under a Cooperative Research and Development Agreement with Merck.

The full listing of pembrolizumab abstracts and presentations at AACR
include:

Clinical Trials Plenary Sessions

• (Abstract #CT004) KEYNOTE-006: PD-L1 expression and
  efficacy in patients (Pts) treated with pembrolizumab (pembro) vs
  ipilimumab (IPI) for advanced melanoma. M. Carlino. Sunday, April
  17, 2:15 p.m. – 4:00 p.m. CDT. Location: La Nouvelle Ballroom, Morial
  Convention Center.
• (Abstract #CT096) Clinical activity, immune and viral
  correlates of PD-1 blockade with pembrolizumab as first systemic
  therapy in patients with advanced Merkel cell carcinoma. CITN-09. P.
  Nghiem. Tuesday, April 19, 10:30 a.m. – 12:15 p.m. CDT. Location: Room
  391, Morial Convention Center. (NCI-sponsored trial).

Poster Sessions

• (Abstract #543) Preclinical combination strategies to
  enhance the efficacy of the anti-PD-1 antibody pembrolizumab. E.
  Pinheiro. Sunday, April 17, 1:00 p.m. – 5:00 p.m. CDT. Location:
  Section 26, Morial Convention Center.
• (Abstract #562) Dinaciclib induces immunogenic cell
  death and enhances anti-PD-1 mediated tumor suppression. D.
  Hossain. Sunday, April 17, 1:00 p.m. – 5:00 p.m. CDT. Location:
  Section 26, Morial Convention Center.
• (Abstract #CT027) A phase I, open-label study of
  GSK3174998 administered alone and in combination with pembrolizumab in
  patients (pts) with selected advanced solid tumors (ENGAGE-1). J.
  Infante. Monday, April 18, 8:00 a.m. – 12:00 p.m. CDT. Location:
  Section 13, Morial Convention Center.
• (Abstract #CT112) Exposure-response analysis of
  pembrolizumab in patients with advanced melanoma and non-small cell
  lung cancer enrolled in KEYNOTE-001, -002, and -006. M.
  Chatterjee. Tuesday, April 19, 1:00 p.m. – 5:00 p.m. CDT. Location:
  Section 13, Morial Convention Center.
• (Abstract #CT125) A phase III randomized trial
  comparing FDA approved standard of care adjuvant therapy to one year
  of pembrolizumab in patients with high risk resected melanoma. SWOG
  1404. K. Grossmann. Tuesday, April 19, 1:00 p.m. – 5:00 p.m. CDT.
  Location: Section 13, Morial Convention Center. (NCI-sponsored trial).
• (Abstract #4359) Rescue of exhausted CD8 T cells by
  PD-1 targeted therapies is CD28-dependent. A. Kamphorst. Tuesday,
  April 19, 3:05 p.m. – 3:20 p.m. CDT. Location: New Orleans Theater C,
  Morial Convention Center.
• (Abstract #4989) Toxicity profile of contemporaneous
  PD-1 inhibitor immunotherapy and radiotherapy. T. Wilhite.
  Wednesday, April 20, 8:00 a.m. – 12:00 p.m. CDT. Location: Section 26,
  Morial Convention Center.

About KEYTRUDA^® (pembrolizumab) Injection
100 mg

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 indicated in the United States for the treatment of patients
with unresectable or metastatic melanoma.

KEYTRUDA is also indicated for the treatment of patients with metastatic
non-small cell lung cancer (NSCLC) whose tumors express PD-L1 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 NSCLC
indication is approved under accelerated approval based on tumor
response rate and durability of response. An improvement in survival or
disease-related symptoms has not yet been established. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in the confirmatory trials.

KEYTRUDA is administered at a dose of 2 mg/kg as an intravenous infusion
over 30 minutes every three weeks for the approved indications.

Selected Important Safety Information for KEYTRUDA^® (pembrolizumab)

Immune-mediated pneumonitis, including fatal cases, occurred in patients
receiving KEYTRUDA. Pneumonitis occurred in 32 (2%) of 1,567 patients
with melanoma, including Grade 1 (0.8%), 2 (0.8%), and 3 (0.4%)
pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550 patients with
non-small cell lung cancer (NSCLC), including Grade 2 (1.1%), 3 (1.3%),
4 (0.4%), or 5 (0.2%) pneumonitis and more frequently in patients with a
history of asthma/chronic obstructive pulmonary disease (5.4%) or prior
thoracic radiation (6.0%). 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.

Immune-mediated colitis occurred in 31 (2%) of 1,567 patients with
melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%) colitis.
Immune-mediated colitis occurred in 4 (0.7%) of 550 patients with NSCLC,
including Grade 2 (0.2%) or 3 (0.4%) 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.

Immune-mediated hepatitis occurred in 16 (1%) of 1,567 patients with
melanoma, including Grade 2 (0.1%), 3 (0.7%), 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.

Hypophysitis occurred in 13 (0.8%) of 1,567 patients with melanoma,
including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%) hypophysitis.
Hypophysitis occurred in 1 (0.2%) of 550 patients with NSCLC, which was
Grade 3 in severity. 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.

Hyperthyroidism occurred in 51 (3.3%) of 1,567 patients with melanoma,
including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism. Hypothyroidism
occurred in 127 (8.1%) of 1,567 patients with melanoma, including Grade
3 (0.1%) hypothyroidism. Hyperthyroidism occurred in 10 (1.8%) of 550
patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%)
hyperthyroidism. Hypothyroidism occurred in 38 (6.9%) of 550 patients
with NSCLC, including Grade 2 (5.5%) or 3 (0.2%) hypothyroidism. Thyroid
disorders can occur at any time during treatment. 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
(pembrolizumab) for Grade 3 or 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 3
(0.1%) of 2,117 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.

Immune-mediated nephritis occurred in 7 (0.4%) of 1,567 patients with
melanoma, including Grade 2 (0.2%), 3 (0.2%) and Grade 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.

Other clinically important immune-mediated adverse reactions can occur.
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 immune-mediated 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 1567 patients
with melanoma: arthritis (1.6%), exfoliative dermatitis, bullous
pemphigoid, uveitis, myositis, Guillain-Barré syndrome, myasthenia
gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures
arising in a patient with inflammatory foci in brain parenchyma. The
following clinically significant, immune-mediated adverse reactions
occurred in less than 1% of 550 patients with NSCLC: rash, vasculitis,
hemolytic anemia, serum sickness, and myasthenia gravis.

Severe and life-threatening infusion-related reactions have been
reported in 3 (0.1%) of 2,117 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 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 (pembrolizumab).

In Trial 6, KEYTRUDA was discontinued due to adverse reactions in 9% of
555 patients with advanced melanoma; adverse reactions leading to
discontinuation in more than one patient were colitis (1.4%), autoimmune
hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and
cardiac failure (0.4%). Adverse reactions leading to interruption of
KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea
(2.5%). The most common adverse reactions with KEYTRUDA vs. ipilimumab
were fatigue (28% vs. 28%), diarrhea (26% with KEYTRUDA), rash (24% vs.
23%), and nausea (21% with KEYTRUDA). Corresponding incidence rates are
listed for ipilimumab only for those adverse reactions that occurred at
the same or lower rate than with KEYTRUDA.

In Trial 2, KEYTRUDA was discontinued due to adverse reactions in 12% of
357 patients with advanced melanoma; the most common (≥1%) were general
physical health deterioration (1%), asthenia (1%), dyspnea (1%),
pneumonitis (1%), and generalized edema (1%). Adverse reactions leading
to interruption of KEYTRUDA occurred in 14% of patients; the most common
(≥1%) were dyspnea (1%), diarrhea (1%), and maculo-papular rash (1%).
The most common adverse reactions with KEYTRUDA vs. chemotherapy were
fatigue (43% with KEYTRUDA), pruritus (28% vs. 8%), rash (24% vs. 8%),
constipation (22% vs. 20%), nausea (22% with KEYTRUDA), diarrhea (20%
vs. 20%), and decreased appetite (20% with KEYTRUDA). Corresponding
incidence rates are listed for chemotherapy only for those adverse
reactions that occurred at the same or lower rate than with KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 14% of 550
patients with NSCLC. Serious adverse reactions occurred in 38% of
patients. The most frequent serious adverse reactions reported in 2% or
more of patients were pleural effusion, pneumonia, dyspnea, pulmonary
embolism, and pneumonitis. The most common adverse reactions (reported
in at least 20% of patients) were fatigue (44%), decreased appetite
(25%), cough (29%), and dyspnea (23%).

No formal pharmacokinetic drug interaction studies have been conducted
with KEYTRUDA.

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. 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
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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 Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf

Merck
Media:
Pam Eisele, 267-305-3558
Kim Hamilton, 908-740-1863
or
Investor:
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879