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May 14, 2014 7:00 am ET

• Six oral presentations report MK-3475 monotherapy data across three different tumor types and multiple lines of therapy
• Late-breaker presentation of long-term findings of MK-3475 in advanced melanoma, including ipilimumab-naïve and treated settings; data included in ASCO Press Program
• First presentation of findings evaluating MK-3475 as initial treatment of patients with advanced non-small cell lung cancer
• First presentation of findings of MK-3475 in recurrent/metastatic head and neck cancer

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that new data for the company’s investigational
anti-PD-1 antibody, MK-3475, in advanced melanoma, non-small cell lung
cancer (NSCLC), and head and neck cancer, are scheduled to be presented
at the 50^th Annual Meeting of the American Society of
Clinical Oncology (ASCO) in Chicago on May 30 – June 3, 2014. The first
presentation of data for MK-3475 as initial treatment in advanced NSCLC
(Abstract #8007) – where chemotherapy is currently the standard of care
— and for the treatment of advanced head and neck cancer (Abstract
#6011) will be part of oral sessions at ASCO 2014. The broad MK-3475
dataset to be highlighted across multiple tumors and lines of therapy
comprises 16 abstracts, with half being oral presentations or poster
discussions.

“Through our broad immuno-oncology-focused development program Merck is
striving to help improve survival for people with advanced
malignancies,” said Dr. Roger M. Perlmutter, president, Merck Research
Laboratories. “The data to be presented expands our understanding of the
effects of monotherapy with MK-3475, and will serve as a foundation for
future studies of combination therapies in an even broader set of
malignancies.”

Presentations in Advanced Melanoma

Merck has a broad development program in advanced melanoma evaluating
MK-3475 across multiple stages of disease, lines of therapy and in
combination with other anti-cancer agents. The company currently has two
Phase 3 studies ongoing in advanced melanoma, and one planned for
adjuvant treatment in the same indication.

Data evaluating MK-3475 in advanced melanoma will be the subject of four
oral presentations and a poster discussion, including long-term data
from Merck’s large ongoing Phase 1b trial (KEYNOTE-001).

• On Monday, June 2, as part of a late-breaker abstract session, data
  from a study of 411 patients with advanced melanoma treated with
  MK-3475 will be presented; these data will also be highlighted in the
  ASCO Press Program (embargoed until 6:30 AM CDT) (Abstract #LBA9000).
  This study evaluated MK-3475 in patients across all lines of therapy
  including those previously-treated with ipilimumab.
• On Monday, June 2, a study evaluating baseline factors including tumor
  size as an independent predictor for overall survival (OS) in patients
  with advanced melanoma treated with MK-3475 will be presented as a
  poster discussion (Abstract #3015).
• On Tuesday, June 3, data in patients with advanced melanoma will be
  presented in three separate oral presentations: one evaluating
  durability of response and OS from the longest ongoing MK-3475
  melanoma cohort of KEYNOTE-001 (Abstract #3005), another on the effect
  of different doses of MK-3475 (Abstract #3000) across different
  patient populations; and a third on observations of unique response
  patterns to MK-3475 based on immune-related response criteria (irRC)
  (Abstract #3006).

Presentations in Advanced Lung Cancer

Merck is advancing a clinical program in NSCLC evaluating MK-3475 as
monotherapy and in combination across lines of therapy, and is exploring
different tumor characteristics such as PD-L1 expression as predictors
of responsiveness. Phase 3 studies with MK-3475 are currently ongoing in
previously-treated advanced NSCLC patients, and Merck plans to initiate
a Phase 3 trial in first-line treatment in 2014.

On Monday, June 2, the first presentation of data for MK-3475 as initial
therapy for advanced NSCLC (KEYNOTE-001) will be the subject of an oral
session (Abstract #8007). On Tuesday, June 3, updated results including
durability of response in patients with previously-treated advanced
NSCLC (KEYNOTE-001) will be presented as a poster discussion (Abstract
#8020).

Presentation in Head and Neck Cancer

On Sunday, June 1, the first presentation of a study evaluating MK-3475
in patients with recurrent and metastatic head and neck cancer
(KEYNOTE-012) expressing PD-L1 will be featured in an oral session
(Abstract #6011). The company announced recently that a new Phase 3
study is planned in advanced head and neck cancer in 2014.

Full session information on MK-3475 data and other findings on Merck’s
marketed anti-cancer and supportive care products can be accessed
through the ASCO iplanner: https://iplanner.asco.org/am2014/AM2014.aspx.

Regulatory Status of MK-3475

On May 6, 2014, Merck announced
that the Biologics License Application (BLA) for MK-3475 has been
accepted for priority review by the U.S. Food and Drug Administration
(FDA) for the treatment of patients with advanced melanoma
previously-treated with ipilimumab; the PDUFA date is October 28, 2014.
The company also announced plans to file a Marketing Authorization
Application for MK-3475 for advanced melanoma in Europe by the end of
2014.

Merck’s Research Focus on Immuno-Oncology

Harnessing immune mechanisms to fight cancer is the priority focus of
Merck’s oncology research and development program. Today, MK-3475, an
investigational anti-PD-1 antibody, is being evaluated across more than
30 types of cancers, as monotherapy and in combination. More than 24
trials including seven Phase 3 studies are either ongoing or anticipated
to start in 2014. The company is advancing Phase 1 studies with MK-4166,
an investigational anti-GITR antibody, clinical studies of
immunomodulatory combination regimens, and preclinical evaluation of
other immunotherapy candidates for the treatment of cancer. For
information about Merck’s oncology clinical studies, please click here.

About Merck Oncology

At Merck Oncology, our goal is to translate breakthrough science into
biomedical innovations to help people with cancer worldwide. Cancer is
one of the world’s most urgent unmet medical needs. Helping to empower
people to fight cancer is our passion. For more information about
Merck’s commitment to Oncology please visit the Oncology Information
Center at http://www.mercknewsroom.com/oncology-infocenter.

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
consumer care 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
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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 2013 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).

Merck
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