2015 ASCO Annual Meeting: New Data in 10 Different Cancers from Merck’s Rapidly Expanding Immuno-Oncology Research Program for KEYTRUDA® (pembrolizumab) to be Presented


May 13, 2015 4:00 pm ET

New Findings Show Anti-tumor Activity of KEYTRUDA in Five Additional Cancers: Colorectal, Esophageal, Ovarian, Renal Cell Carcinoma and Small-Cell Lung Cancer

First-Time Presentations of DNA Mismatch Repair Deficiency Data in Colorectal and other Cancers and Nanostring RNA Data in Melanoma, Head and Neck and Gastric Cancers

Industry-leading Number of PD-1 Clinical Trials Resulting in Growing Body of Data for KEYTRUDA across 13 Tumor Types

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that new investigational data in 10 different types of
cancer from the company’s immuno-oncology development program evaluating
its anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), will be
presented at the 51st Annual Meeting of the American Society
of Clinical Oncology (ASCO) in Chicago, May 29 – June 2, 2015. Merck is
advancing a comprehensive clinical development program for KEYTRUDA, a
fact reflected in the more than 40 abstracts accepted for this year’s
ASCO meeting, including 11 oral presentations of which two are
late-breakers (Abstract #LBA6008 and #LBA100) selected for the official
ASCO press program on Friday, May 29.

“At Merck, we are executing a broad and deep immuno-oncology research
program – now in more than 85 studies and 30 different tumor types – to
understand the potential for KEYTRUDA in a broad range of cancers, at
different stages, lines of therapy, both alone and in combination,” said
Dr. Roy Baynes, senior vice president and head of global clinical
development, Merck Research Laboratories. “This commitment to
breakthrough science has thus far yielded data supporting the potential
of KEYTRUDA in 13 different cancers. With our collaborators in the
cancer community, we remain focused on pursuing our clinical research
program with the goal of advancing therapies with meaningful benefit to
patients with cancer.”

Merck’s Immuno-Oncology Data at 2015 ASCO Annual Meeting

First-time presentation of findings with KEYTRUDA are anticipated in
five additional tumor types – colorectal, esophageal, ovarian, renal
cell carcinoma (RCC) and small-cell lung cancer (SCLC) – as well as new
data in advanced bladder, gastric, head and neck, melanoma and non-small
cell lung cancer (NSCLC). These studies will evaluate KEYTRUDA as
monotherapy and in combination with other therapies – including across
different patient sub-groups, lines of therapy and based on biomarker
expression. There will be first-time presentations of data for KEYTRUDA
that evaluate nanostring RNA signatures and DNA mismatch repair
deficiency as potential biomarkers for improved efficacy across
different types of cancer. A select list of sessions, including oral
presentations, clinical science symposia and poster discussions,
included in the 2015 ASCO program is provided below.

Head and Neck Cancer

New results for KEYTRUDA will be presented in advanced head and neck
cancer, including data from an expansion cohort of the KEYNOTE-012 trial
as an oral late-breaker presentation. These data are part of the
official ASCO press program.

  • (Abstract #LBA6008) Late-Breaker Presentation: Antitumor activity
    and safety of pembrolizumab in patients (pts) with advanced squamous
    cell carcinoma of the head and neck (SCCHN): Preliminary results from
    KEYNOTE-012 expansion cohort.
    T. Seiwert. Monday, June 1, 3:39 PM
    – 3:51 PM CDT. Location: S100bc. ASCO Press Program, Friday, May 29,
    1:00 PM CDT.
  • (Abstract #6017) Poster Discussion: Inflamed-phenotype gene
    expression signatures to predict benefit from the anti-PD-1 antibody
    pembrolizumab in PD-L1+ head and neck cancer patients.
    T. Seiwert.
    Saturday, May 30, 1:15 PM – 4:45 PM CDT (poster session). Location: S
    Hall A. 4:45 PM – 6:00 PM CDT (discussion). Location: S406.


Merck has a broad development program in melanoma evaluating KEYTRUDA
across multiple stages of disease, lines of therapy and in combination
with other anti-cancer agents. KEYTRUDA was the first anti-PD-1 therapy
approved in the United States and is currently indicated in the United
States at a 2 mg/kg dose every three weeks for the treatment of patients
with unresectable or metastatic melanoma and disease progression
following ipilimumab and, if BRAF V600 mutation positive, a BRAF
inhibitor. Please see below for complete indication and selected safety
information for KEYTRUDA. At ASCO, data evaluating KEYTRUDA in advanced
melanoma will be the subject of three oral presentations and several
poster discussions.

  • (Abstract #9005) Oral Presentation: Long-term efficacy of
    pembrolizumab (pembro; MK-3475) in a pooled analysis of 655 patients
    (pts) with advanced melanoma (MEL) enrolled in KEYNOTE-001.
    Daud. Saturday, May 30, 2:39 PM – 2:51 PM CDT. Location: E354b.
  • (Abstract #3000) Oral Presentation: Atypical patterns of response
    in patients (pts) with metastatic melanoma treated with pembrolizumab
    (MK-3475) in KEYNOTE-001.
    J. Wolchok. Monday, June 1, 1:15 PM –
    1:27 PM CDT. Location: S406.
  • (Abstract #3001) Oral Presentation: Association of response to
    programmed death receptor 1 (PD-1) blockade with pembrolizumab
    (MK-3475) with an interferon-inflammatory immune gene signature.

    A. Ribas. Monday, June 1, 1:27 PM – 1:39 PM CDT. Location: S406.
  • (Abstract #3009) Poster Discussion: Pembrolizumab (MK-3475) plus
    low-dose ipilimumab (IPI) in patients (pts) with advanced melanoma
    (MEL) or renal cell carcinoma (RCC): Data from the KEYNOTE-029 phase 1
    M. Atkins. Saturday, May 30, 8:00 AM – 11:30 AM CDT (poster
    session). Location: S Hall A. 3:00 PM – 4:15 PM CDT (discussion).
    Location: S406.

Lung Cancer

Merck has a broad lung cancer development program for KEYTRUDA across
all histologies, multiple lines of therapy and in combination, and based
on tumor characteristics such as PD-L1 expression. At ASCO, first-time
presentations include early findings with KEYTRUDA monotherapy in SCLC
and as combination therapy in NSCLC.

  • (Abstract #8011) Clinical Science Symposium: Phase I study of
    pembrolizumab (pembro; MK-3475) plus ipilimumab (IPI) as second-line
    therapy for advanced non-small cell lung cancer (NSCLC): KEYNOTE-021
    cohort D.
    A. Patnaik. Sunday, May 31, 4:54 PM – 5:06 PM CDT.
    Location: E Hall D1.
  • (Abstract #7502) Oral Presentation: Pembrolizumab (MK-3475) in
    patients (pts) with extensive-stage small cell lung cancer (SCLC):
    Preliminary safety and efficacy results from KEYNOTE-028.
    P. Ott.
    Saturday, May 30, 3:48 PM – 4:00 PM CDT. Location: E Hall D1.

Additional Cancers

Early data for KEYTRUDA from Merck’s immuno-oncology development program
will also be presented in a number of difficult-to-treat cancers. For
the first time, data will be presented exploring the potential of an
anti-PD-1 therapy in colorectal cancer and other solid tumors based on
DNA mismatch repair deficiency, which is evident in different cancers.
These data are part of the official ASCO press program.

  • (Abstract #LBA100) Late-Breaker Presentation: PD-1 blockade in
    tumors with mismatch repair deficiency.
    D. Le. Saturday, May 30,
    8:05 AM – 8:17 AM CDT. Location: E Hall D1. ASCO Press Program,
    Friday, May 29, 1:00 PM CDT.
  • (Abstract #4001) Oral Presentation: Relationship between PD-L1
    expression and clinical outcomes in patients with advanced gastric
    cancer treated with the anti-PD-1 monoclonal antibody pembrolizumab
    (MK-3475) in KEYNOTE-012.
    Y. Bang. Sunday, May 31, 8:12 AM – 8:24
    AM CDT. Location: E Hall D2.
  • (Abstract #4010) Clinical Science Symposium: Pembrolizumab
    (MK-3475) for patients (pts) with advanced esophageal carcinoma:
    Preliminary results from KEYNOTE-028.
    T. Doi. Sunday, May 31, 4:54
    PM – 5:06 PM CDT. Location: E Hall D2.
  • (Abstract #4502) Oral Presentation: Pembrolizumab (MK-3475) for
    advanced urothelial cancer: Updated results and biomarker analysis
    from KEYNOTE-012.
    E. Plimack. Monday, June 1, 10:09 AM – 10:21 AM
    CDT. Location: E Arie Crown Theater.
  • (Abstract #5510) Clinical Science Symposium: Antitumor activity and
    safety of pembrolizumab in patients (pts) with PD-L1 positive advanced
    ovarian cancer: Interim results from a phase Ib study.
    A. Varga.
    Monday, June 1, 3:12 PM – 3:24 PM CDT. Location: E354b.

Additional Data

Data from studies of other Merck approved medicines and pipeline
candidates will also be presented at the meeting. For more information,
including a complete list of abstract titles, please visit the ASCO
website at https://iplanner.asco.org/AM2015.

Merck Oncology Briefing Webcast

Merck will hold a webcast in conjunction with the 2015 ASCO Annual
Meeting on June 1 at 7:30 p.m. CDT. Investors and journalists may access
the live audio webcast of the event on Merck’s website at www.merck.com.
Software needed to listen to the webcast is available on the corporate
website and should be downloaded prior to the beginning of the webcast.
Institutional investors, analysts and members of the media can also
listen to the event by dialing (866) 486-2604 or (706) 634-1286 and
using ID code number 45855476.

About KEYTRUDA® (pembrolizumab)

KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks
the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By
binding to the PD-1 receptor and blocking the interaction with the
receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition
of the immune response, including the anti-tumor immune response.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg
administered as an intravenous infusion over 30 minutes every three
weeks for the treatment of patients with unresectable or metastatic
melanoma and disease progression following ipilimumab and, if BRAF V600
mutation positive, a BRAF inhibitor. This 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.

Merck is advancing a broad and fast-growing clinical development program
for KEYTRUDA with more than 85 clinical trials – across more than 30
tumor types and over 14,000 patients – both as a monotherapy and in
combination with other therapies.

Selected Important Safety Information for KEYTRUDA

Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced melanoma
receiving KEYTRUDA (the approved indication in the United States),
including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients,
respectively. 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

Colitis (including microscopic colitis) occurred in 4 (1%) of 411
patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients
respectively, receiving KEYTRUDA. 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.

Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411
patients, including a Grade 4 case in 1 (0.2%) patient, receiving
KEYTRUDA. 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 2 (0.5%) of 411 patients, including a Grade 2
case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving
KEYTRUDA. Monitor for signs and symptoms of hypophysitis. Administer
corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA
for Grade 2; withhold or discontinue for Grade 3; and permanently
discontinue KEYTRUDA for Grade 4 hypophysitis.

Nephritis occurred in 3 (0.7%) patients receiving KEYTRUDA, consisting
of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of
interstitial nephritis with renal failure (0.5%), one Grade 3 and one
Grade 4. 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.

Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2
or 3 cases in 2 (0.5%) and 1 (0.2%) patients respectively, receiving
KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients,
including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA.
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 corticosteroids for Grade 3 or greater hyperthyroidism.
Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for
Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with
replacement therapy without treatment interruption and without

Other clinically important immune-mediated adverse reactions can occur.
The following clinically significant, immune-mediated adverse reactions
occurred in less than 1% of patients treated with KEYTRUDA: exfoliative
dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic
anemia, partial seizures arising in a patient with inflammatory foci in
brain parenchyma, adrenal insufficiency, myasthenic syndrome, optic
neuritis, and rhabdomyolysis.

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 of the adverse reaction to Grade 1 or
less, initiate corticosteroid taper and continue to taper over at least
1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or
less. Permanently discontinue KEYTRUDA for any severe or Grade 3
immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.

Based on its mechanism of action, KEYTRUDA may 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.

For the treatment of advanced melanoma, KEYTRUDA was discontinued for
adverse reactions in 6% of 89 patients who received the recommended dose
of 2 mg/kg and 9% of 411 patients across all doses studied. Serious
adverse reactions occurred in 36% of patients receiving KEYTRUDA. The
most frequent serious adverse drug reactions reported in 2% or more of
patients were renal failure, dyspnea, pneumonia, and cellulitis.

The most common adverse reactions (reported in ≥20% of patients) were
fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%),
decreased appetite (26%), constipation (21%), arthralgia (20%), and
diarrhea (20%).

The recommended dose of KEYTRUDA is 2 mg/kg administered as an
intravenous infusion over 30 minutes every three weeks until disease
progression or unacceptable toxicity. 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. 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 healthcare 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 healthcare through
far-reaching policies, programs and partnerships. For more information,
visit www.merck.com
and connect with us on Twitter,
and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’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 healthcare legislation in the
United States and internationally; global trends toward healthcare cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’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 Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck 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 Merck’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 the Medication Guide for KEYTRUDA at

Pamela Eisele, 267-305-3558
Claire Mulhearn, 908-236-1118
Joseph Romanelli, 908-740-1986
Justin Holko, 908-740-1879

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