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January 19, 2016 10:00 am ET

Seven Registration-Enabling Trials Evaluating KEYTRUDA in Patients with Gastrointestinal Cancers are Planned or Underway

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that new and updated findings investigating the use of
KEYTRUDA^® (pembrolizumab), the company’s anti-PD-1 therapy,
in multiple gastrointestinal cancers will be presented at this year’s
Gastrointestinal (GI) Cancers Symposium in San Francisco, Jan. 21 – 23.
Updates on pembrolizumab include data on advanced esophageal carcinoma
and new preliminary Phase 2 safety data in gastric cancer.

“Advanced gastrointestinal cancers are difficult to treat and new
therapies are needed,” said Roger Dansey, M.D., senior vice president
and therapeutic area head, oncology late-stage development, Merck
Research Laboratories. “Through our rapidly advancing clinical program,
we have seen promising results with KEYTRUDA in several gastrointestinal
cancers, and are hopeful about the potential of KEYTRUDA for these
patients.”

The KEYTRUDA clinical trials program currently includes more than 30
tumor types in more than 200 clinical trials, including more than 80
trials that combine KEYTRUDA with other cancer treatments. More than 20
of these trials are evaluating KEYTRUDA in gastrointestinal cancers,
including seven registration-enabling studies in gastric cancer,
colorectal cancer and esophageal cancer. Registration-enabling trials of
KEYTRUDA are also currently enrolling patients with melanoma, non-small
cell lung cancer, head and neck cancer, bladder cancer, Hodgkin
lymphoma, multiple myeloma, and breast cancer, and further trials are
being planned for other malignancies.

Merck’s Immuno-Oncology Data at the 2016 GI Cancers Symposium

A full listing of KEYTRUDA abstracts for both oral and poster sessions
is below:

Oral Presentations

• (Abstract #7) Updated results for the advanced
  esophageal carcinoma cohort of the phase 1b KEYNOTE-028 study of
  pembrolizumab (MK-3475). T. Doi. Poster Presentation:
  Thursday, Jan. 21, 12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST. Oral
  Presentation: Thursday, Jan. 21, 2:00 – 3:30 p.m. PST. Location:
  Moscone West Building.
• (Abstract #195) PD-1 blockade in mismatch repair
  deficient non-colorectal gastrointestinal cancers. D. Le. Poster
  Presentation: Friday, Jan. 22, 12:30 – 2:00 p.m. and 5:30 – 7:00 p.m.
  PST. Oral Presentation: Friday, Jan. 22, 2:00 – 3:30 p.m. PST.
  Location: Moscone West Building.

Poster Presentations

• (Abstract #TPS161) Pembrolizumab (MK-3475) plus
  5-fluorouracil (5-FU) and cisplatin for first-line treatment of
  advanced gastric cancer: Preliminary safety data from KEYNOTE-059. C.
  Fuchs. Thursday, Jan. 21, 12:30 – 2:00 p.m. and 5:30 – 7:00
  p.m. PST. Location: Moscone West Building.
• (Abstract #TPS183) Pembrolizumab (MK-3475) versus
  paclitaxel as second-line therapy for advanced gastric or
  gastroesophageal junction (GEJ) adenocarcinoma: Phase 3 KEYNOTE-061
  study. A. Ohtsu. Thursday, Jan. 21, 12:30 – 2:00 p.m. and
  5:30 – 7:00 p.m. PST. Location: Moscone West Building.
• (Abstract #TPS184) Pembrolizumab (MK-3475) for
  recurrent or metastatic gastric or gastroesophageal junction (GEJ)
  adenocarcinoma: Multicohort phase II KEYNOTE-059 study. C. Fuchs.
  Thursday, Jan. 21, 12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST.
  Location: Moscone West Building.
• (Abstract #TPS185) KEYNOTE-062: Phase III study of
  pembrolizumab (MK-3475) alone or in combination with chemotherapy
  versus chemotherapy alone as first-line therapy for advanced gastric
  or gastroesophageal junction (GEJ) adenocarcinoma. J. Tabernero.
  Thursday, Jan. 21, 12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST.
  Location: Moscone West Building.
• (Abstract #TPS189) Pembrolizumab (MK-3475) for
  previously treated metastatic adenocarcinoma or squamous cell
  carcinoma of the esophagus: Phase II KEYNOTE-180 study. M. Shah.
  Thursday, Jan. 21, 12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST.
  Location: Moscone West Building.
• (Abstract #465) Phase 1/2a study of double immune
  suppression blockade by combining a CSF1R inhibitor
  (pexidartinib/PLX3397) with an anti PD-1 antibody (pembrolizumab) to
  treat advanced melanoma and other solid tumors. Z. Wainberg. Friday,
  Jan. 22, 12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST. Location: Moscone
  West Building.
• (Abstract #TPS787) KEYNOTE-164: Phase II study of
  pembrolizumab (MK-3475) for patients with previously treated,
  microsatellite instability-high advanced colorectal carcinoma. D.
  Le. Saturday, Jan. 23, 7:00 – 7:55 a.m. and 12:30 – 2:00 p.m.
  PST. Location: Moscone West Building.
• (Abstract #TPS789) KEYNOTE-177: First-line,
  open-label, randomized, phase 3 study of pembrolizumab (MK-3475)
  versus investigator-choice chemotherapy for mismatch repair deficient
  or microsatellite instability-high metastatic colorectal carcinoma. L
  Diaz. Saturday, Jan. 23, 7:00 – 7:55 a.m. and 12:30 – 2:00 p.m.
  PST. Location: Moscone West Building.

About Gastrointestinal Cancer

Gastrointestinal cancer is a term for a group of cancers that affect the
digestive system, including cancers of the esophagus, gallbladder,
liver, pancreas, stomach, small intestine, colon, rectum, and anus.
Cancer of the colon or rectum, also called colorectal cancer, is the
third most common cancer in men and the second most common cancer in
women worldwide, accounting for more than 600,000 cases each year.
Esophageal cancer, a type of cancer that begins in the inner layer of
the esophagus, is the eighth most common cancer worldwide with an
estimated 456,000 new cases diagnosed in 2012.

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. 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 were fatigue (28% with
KEYTRUDA vs. 28% with ipilimumab), diarrhea (26% with KEYTRUDA), rash
(24% with KEYTRUDA vs. 23% with ipilimumab), 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 were fatigue (43% with KEYTRUDA),
pruritus (28% with KEYTRUDA vs. 8% with chemotherapy), rash (24% with
KEYTRUDA vs. 8% with chemotherapy), constipation (22% with KEYTRUDA vs.
20% with chemotherapy), nausea (22% with KEYTRUDA), diarrhea (20% with
KEYTRUDA vs. 20% with chemotherapy), 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

Today’s Merck is 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,
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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
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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 2014 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
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An Phan, 908-255-6325
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