Merck’s Investigational Anti-PD1 Antibody, MK-3475, Active in Three Different Tumor Types: New Data to be Presented at the 2014 ASCO Annual Meeting

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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 50th 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
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subject to significant risks and uncertainties. There can be no
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including obtaining regulatory approval; Merck’s ability to accurately
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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).

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