Pembrolizumab Demonstrated 28 Percent Overall
Response Rate and 76 Percent Disease Control Rate in
Difficult-to-Treat Cancer
First Findings from KEYNOTE-028, Merck's
Innovative Basket Trial in 20 Cancers
KIRKLAND,
QC, April 19, 2015 /CNW
Telbec/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation
of data investigating the use of pembrolizumab, the company's
investigational anti-PD-1 therapy, in 25 patients with advanced
pleural mesothelioma, a difficult-to-treat cancer of the lining of
the lungs, abdomen and other organs. The early findings presented
showed an overall response rate (confirmed and unconfirmed) of 28
percent with pembrolizumab in patients with tumours that expressed
PD-L1. Additionally, 48 percent of patients had stable disease,
resulting in a disease control rate of 76 percent. These data, from
KEYNOTE-028, will be presented today at the American Association
for Cancer Research (AACR) Annual Meeting by Dr. Evan Alley, Abramson Cancer Center, University of Pennsylvania, and were part of the
AACR official press program (abstract #CT103). This is the first
data to be presented from KEYNOTE-028, Merck's innovative basket
trial designed to evaluate the efficacy and safety of pembrolizumab
in patients with 20 difficult-to-treat cancers.
"This presentation at AACR marks the first time
that data involving an investigational anti-PD-1 therapy have been
presented in pleural mesothelioma, which is a rare, hard-to-treat
cancer with very limited treatment options," said Dr. Alley,
clinical associate professor of medicine, Abramson Cancer Center.
"While early, the disease control rates observed in this study are
very encouraging, and indicate that further study is warranted to
evaluate the potential role of pembrolizumab in the treatment of
malignant pleural mesothelioma."
"This unique study is helping to accelerate our
understanding of where pembrolizumab may work in cancers with
limited or no treatment options," said Dr. Roger Dansey, therapeutic area head and senior
vice president, oncology late stage development, Merck Research
Laboratories. "These early data in advanced pleural mesothelioma
reinforce the clinically meaningful results we are seeing with
pembrolizumab across multiple cancers."
At the time of the analysis, 40 percent of
patients (n=10/25) remained on treatment. Adverse events in the
study were consistent with previously reported safety data for
pembrolizumab. The most common treatment-related adverse events
(occurring in greater than twenty percent of patients) were fatigue
(24%) and nausea (24%). Two Grade 3 treatment-related adverse
events occurred: ALT increased (n=1) and thrombocytopenia (n=1).
Some patients experienced adverse events of special interest,
including rash (n=4), ALT/AST increased (n=1), hypersensitivity
(n=1) and iridocyclitis (n=1); two required a dose interruption
(one because of ALT/AST increased, one because of iridocyclitis).
No patients discontinued as a result of treatment-related adverse
events, and there were no treatment-related deaths.
About the KEYNOTE-028 Study
KEYNOTE-028 is an ongoing, multi-cohort,
non-randomized Phase 1b basket trial evaluating the safety,
tolerability, and anti-tumour activity of pembrolizumab monotherapy
(10 mg/kg dosed every two weeks) in 320 patients with PD-L1
positive advanced solid tumours that have not responded to current
therapy or for which current therapy is not appropriate.
About Pembrolizumab
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, pembrolizumab releases the PD-1
pathway-mediated inhibition of the immune response, including the
anti-tumour immune response.
Merck is advancing a broad and fast-growing
clinical development program for pembrolizumab with more than 85
clinical trials – across more than 30 tumour types and over 14,000
patients – both as a monotherapy and in combination with other
therapies.
About Malignant Mesothelioma1
Malignant mesotheliomas are cancers of a covering tissue that
lines the lung, abdomen, heart and testes. There are four main
types of mesotheliomas that are named based on where they develop:
the chest (pleural mesotheliomas); the abdomen (peritoneal
mesotheliomas); the covering around the heart (pericardial
mesotheliomas); and the covering layer of the testicles
(mesotheliomas of the tunica vaginalis). In 2010, 515 Canadians,
(415 men and 95 women) were diagnosed with mesothelioma. In
2009, 421 Canadians died from mesothelioma, (355 men, 66 women).
The main risk factor for developing mesothelioma is exposure to
asbestos; others include infection with simian virus 40 (SV40),
older age (65 or older), and male gender.
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 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 Canada and the
United States. 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 about our
operations in Canada, visit
www.merck.ca.
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 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; Merck's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
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effectiveness of Merck's patents and other protections for
innovative products; and the exposure to litigation, including
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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).
# # #
1 Canadian Cancer Society. Mesothelioma.
Retrieved on April 16, 2015 from
https://www.cancer.ca/en/cancer-information/cancer-type/mesothelioma/risks/?region=on
SOURCE Merck