Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab, the Company’s Investigational Anti-PD-1 Antibody, at ESMO 2014


September 2, 2014 7:30 am ET

First Presentation of Findings in Gastric and Bladder (Urothelial Tract) Cancers

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced the presentation of data from ongoing clinical trials
evaluating the anti-tumor activity of pembrolizumab, the company’s
investigational anti-PD-1 antibody, at the European Society of Medical
Oncology (ESMO) 2014 in Madrid, Spain, September 26 – 30. Data on
pembrolizumab are planned to be presented in five advanced solid tumor
types, including the first presentation of data evaluating pembrolizumab
for the treatment of gastric and bladder (urothelial tract) cancers.
Three late-breaking abstracts have been accepted for oral presentation.

“We are pleased to present the first data for our investigational
anti-PD-1 antibody pembrolizumab in gastric and bladder cancers at ESMO
2014,” said Dr. Roy Baynes, senior vice president, Global Clinical
Development, Merck Research Laboratories. “The presentation of data for
five advanced tumor types underscores the breadth of Merck’s
immuno-oncology development program evaluating pembrolizumab in diverse
tumor types, different stages of disease and multiple lines of therapy.”

Abstracts involving Merck Oncology-sponsored studies at ESMO 2014

Bladder and Gastric Cancers

  • (Abstract #LBA23) Late-Breaker (Oral presentation): A
    Phase 1b Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts)
    With Advanced Urothelial Tract Cancer.
    E. Plimack. Monday,
    September 29, 11:00 AM-11:15 AM CEST. Location: Sevilla.
  • (Abstract #LBA15) Late-Breaker (Oral presentation): A
    Phase 1b Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts)
    With Advanced Gastric Cancer
    . K. Muro. Sunday, September 28. 09:15
    AM-09:30 AM CEST. Location: Madrid.

Advanced Melanoma

  • (Abstract #LBA34) Late-Breaker (Poster discussion): Pembrolizumab
    (Pembro; MK-3475) for Advanced Melanoma (MEL): Randomized Comparison
    of Two Dosing Schedules
    . C. Robert, Monday, September 29. 1:00
    PM-2:00 PM CEST. Location: Valencia.
  • (Abstract #1075TiP) Poster: KEYNOTE-029: Phase 1/2
    Study of MK-3475 in Combination With Pegylated Interferon Alfa-2b
    (PEG-IFN) or Ipilimumab (IPI) in Patients (Pts) With Advanced Melanoma
    (MEL) or Renal Cell Carcinoma (RCC)
    . T.K. Choueiri. Monday,
    September 29; 12:45 PM-1:45 PM CEST. Location: Poster Area.
  • (Abstract #1097P) Poster: PD-L1 Expression and
    Overall Survival Among Patients With Melanoma
    . T. Steiniche.
    Sunday, September 28; 12:45 PM-1:45 PM CEST. Location: Poster Area.


  • (Abstract #LBA43) Late-Breaker (Oral presentation):
    Antitumor Activity of Pembrolizumab (Pembro; MK-3475) and Correlation
    With Programmed Death Ligand 1 (PD-L1) Expression in a Pooled Analysis
    of Patients (pts) With Advanced Non–Small Cell Lung Carcinoma (NSCLC)
    E. Garon. Sunday, September 28; 09:15 AM-10:30 AM CEST. Location:
  • (Abstract #1328P) Poster: PD-L1 Expression and
    Survival Among Advanced Non–Small Cell Lung Cancer (NSCLC) Patients
    Treated With Chemotherapy
    . S. Sorensen. Saturday, September 27;
    12:45 PM-1:45 PM CEST. Location: Poster Area.

Head and Neck Cancer

  • (Abstract #LBA31) Late-Breaker (Poster discussion): A
    Phase Ib Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts)
    With Human Papillomavirus Virus (HPV)-Positive and Negative Head and
    Neck Cancer (HNC)
    . L. Chow. Sunday, September 28; 1:00 PM-2:00 PM
    CEST. Location: Poster Area.

For more information about the ESMO Congress and for a complete list of
abstract titles, please refer to

About Pembrolizumab

Pembrolizumab (MK-3475) 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, pembrolizumab releases the PD-1 pathway-mediated
inhibition of the immune response, including the anti-tumor immune

Pembrolizumab is currently being evaluated across more than 30 types of
cancers, as monotherapy and in combination. It is anticipated that by
the end of 2014, the pembrolizumab development program will grow to more
than 24 clinical trials, enrolling an estimated 6,000 patients at nearly
300 clinical trial sites worldwide. For information about Merck’s
oncology clinical trials, please visit

Our Focus on Cancer

Our goal is to translate breakthrough science into biomedical
innovations to help people with cancer worldwide. For Merck Oncology,
helping people fight cancer is our passion, supporting accessibility to
our cancer medicines is our commitment, and pursuing research in
immuno-oncology is our focus to potentially bring new hope to people
with cancer. For information about Merck’s commitment to Oncology visit
the Oncology Information Center at

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
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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
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receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
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Risks and uncertainties include, but are not limited to, general
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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;
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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.

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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
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