Pembrolizumab monotherapy achieved 24
percent overall response rate in patients with PD-L1 positive,
advanced bladder (urothelial) cancer
Planned Phase 3 study in advanced bladder
cancer to be initiated by the end of 2014
MSD, known as Merck in the United States and Canada, today
announced the first presentation of data on the investigational use
of pembrolizumab – the company’s anti-PD-1 therapy – in PD-L1
positive, advanced urothelial cancer, (also known as bladder
cancer). The early findings presented showed a confirmed overall
response rate of 24 percent with pembrolizumab as monotherapy, as
measured by RECIST v1.1, central review (n= 7/29: 95% CI,
10.3-43.5) including a complete response rate of 10 percent (3/29).
At the time of analysis, response durations ranged from 16+ to 40+
weeks with six of the seven responders continuing on therapy. In
the ongoing study, 64 percent (61/95) of patients screened had
tumours that were determined to be positive for PD-L1
expression.
These data, from a cohort of the ongoing Phase 1b KEYNOTE-012
study, were presented today, as part of a late-breaking oral
session, by Dr. Elizabeth R. Plimack, Fox Chase Cancer Center,
Philadelphia, at the European Society for Medical Oncology (ESMO)
2014 Congress in Madrid, Spain (ABSTRACT #LBA23).
“Although at this stage the dataset is small, we are encouraged
by the response rate, complete response rate, and the durability of
the response in patients suffering from advanced bladder cancer,”
said Dr. Alise Reicin, vice president, oncology, Merck Research
Laboratories. “As communicated previously, based on these data, MSD
will initiate a Phase 3 study this year to better understand the
potential of pembrolizumab in advanced bladder cancer.”
Early findings for investigational use of pembrolizumab in
advanced bladder cancer
Data from a cohort of the ongoing Phase 1b KEYNOTE-012 study
evaluated pembrolizumab monotherapy at 10 mg/kg every two weeks in
patients with advanced bladder cancer whose tumours were determined
to be positive for PD-L1 expression (n=29). As measured by MSD’s
proprietary immunohistochemistry (IHC) clinical trial assay,
tumours were classified as PD-L1 positive based on greater than or
equal to one percent of tumour cells demonstrating expression of
the PD-L1 marker, or any positive staining with the same reagent in
tumour stroma. The majority of patients had received one or more
prior lines of therapy.
Antitumour activity by Response Evaluation Criteria in Solid
Tumours (RECIST) v1.1*
Patients Evaluable for
Response (n=29) n Percentage
95% CI Overall Response Rate (ORR) 7 24.1
10.3 – 43.5 Best overall response
3 10.3 2.2 – 27.4
4 13.8 3.9 – 31.7
4 13.8 3.9 – 31.7
14 48.3 29.4 – 67.5
4 13.8 3.9 – 31.7
*Analysis cut-off date: 6 August 2014
At six months, 58 percent of patients were alive and median
overall survival was 9.3 months (95% CI, 3.6-NR). Additionally,
tumour shrinkage was achieved in 64 percent of evaluable patients
with one post-baseline treatment scan. Analysis of the relationship
between PD-L1 expression and clinical outcomes is ongoing.
Adverse events were consistent with previously reported safety
data for pembrolizumab. The most common investigator-assessed,
treatment-related adverse events (occurring in greater than or
equal to two patients) included fatigue (18%), peripheral edema
(12%), and nausea (9%). Grade 3-5 investigator-assessed,
treatment-related adverse events occurred in a total of four
patients. One infusion-related reaction was observed and one
patient discontinued pembrolizumab due to a treatment-related
adverse reaction. There were no treatment-related deaths.
About the KEYNOTE-012 study
KEYNOTE-012 is an ongoing multi-center, non-randomised Phase 1b
trial evaluating the safety, tolerability, and anti-tumour activity
of pembrolizumab monotherapy in patients with advanced triple
negative breast cancer (TNBC), advanced head and neck cancer,
advanced urothelial (bladder) cancer, or advanced gastric cancer.
The primary endpoints of the study include overall safety,
tolerability, and anti-tumour activity (as measured by RECIST v1.1)
in PD-L1 positive tumours; secondary endpoints include
progression-free survival (PFS), overall survival (OS) and duration
of response.
Notes to the Editors
About pembrolizumab
Pembrolizumab is a humanised 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.
About bladder (urothelial tract) cancer
Bladder cancer is the most common form of urothelial cancer, a
cancer that forms in the layer of tissue (also called the
urothelium) that lines the urethra, bladder, ureters, prostate and
renal pelvis.1 Among others, risk factors for bladder cancer
include smoking, exposure to certain industrial chemicals in the
workplace, race, ethnicity, age, and gender.2 The incidence of
bladder cancer is elevated in North America, Europe, North Africa,
the Middle East, Australia and New Zealand.3 In 2012, there were an
estimated 430,000 new cases of bladder cancer and 165,000 bladder
cancer deaths worldwide.3
Our focus on cancer
Our goal is to translate breakthrough science into biomedical
innovations to help people with cancer worldwide. For MSD 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 MSD
Today's MSD is a global healthcare leader working to help the
world be well. MSD is known as Merck in 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.
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 MSD’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 materialise,
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; MSD’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 MSD’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
MSD 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).
1 National Cancer Institute. General Information About Bladder
and Other Urothelial Cancers.
http://www.cancer.gov/cancertopics/pdq/screening/bladder/Patient/page2.
Accessed September 23, 2014.
2 American Cancer Society. What are the risk factors for bladder
cancer?
http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-risk-factors.
Accessed September 23, 2014.
3 WHO. 5.10 Bladder Cancer. In: Stewart BW, Wild CP, eds. World
Cancer Report 2014. Lyon, France: WHO Press; 2014: 681-695.
Media:Ian McConnell, 973-901-5722orClaire Mulhearn,
908-423-7425orInvestor:Joseph Romanelli, 908-423-5185orJustin
Holko, 908-423-5088
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