Exploratory Analyses in Advanced Melanoma
and NSCLC Presented in Oral Session
Dr. Roger Perlmutter to Present at AACR
Opening Plenary Session
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the presentation of early findings from
studies exploring the relationship between tumor PD-L1 expression
and clinical outcomes following monotherapy treatment with MK-3475,
an investigational anti-PD-1 immunotherapy, in patients with
advanced melanoma and advanced non-small cell lung cancer (NSCLC).
Responses were observed in patients with PD-L1 negative tumors;
although the preliminary findings for both tumor types suggest that
higher PD-L1 expression was associated with higher overall response
rates. Further study of the relationship between PD-L1 expression
and responses to MK-3475 as monotherapy and in combination with
other treatments for melanoma, NSCLC and other tumors is ongoing or
planned.
These findings will be presented today in an oral session at the
AACR Annual Meeting 2014 in San Diego and were highlighted within
the official AACR press program. Separately, as part of today’s
opening plenary session, Dr. Roger M. Perlmutter, president, Merck
Research Laboratories, will deliver a plenary lecture entitled
“Tumor-Specific Immune Activation: Immuno-Oncology Comes of
Age”.
“These exploratory analyses are providing us with insightful
information regarding the association of PD-L1 expression and
clinical outcomes with MK-3475,” said Dr. Eric Rubin, vice
president, Oncology, Merck Research Laboratories. “In both types of
advanced cancers studied, we are seeing durable responses in a wide
range of patients, including those with PD-L1 negative tumors. We
will continue to explore PD-L1 expression and other selection
markers across tumors in our MK-3475 development program.”
Preliminary PD-L1 Expression Analysis in Advanced
Melanoma
Preliminary findings on PD-L1 expression in 125 evaluable
advanced melanoma patients, based on a minimum of 6-month follow-up
from the ongoing Phase 1B KEYNOTE-001 study, were presented by Dr.
Adil Daud, co-director of the University of California, San
Francisco (UCSF) Melanoma Center, and director of melanoma clinical
research at the UCSF Helen Diller Family Comprehensive Cancer
Center, (abstract #5013). Results from the preliminary analysis
showed that 71 percent (n=89) of advanced melanoma patients had
positive PD-L1 tumors at the optimally defined cut-point of ≥1
percent of tumor cells stained, as measured by immunohistochemistry
(IHC). An additional cut-point of ≥10 percent of cells stained by
IHC measurement was also evaluated.
In the overall evaluable advanced melanoma population, the
overall response rate was 40 percent (n=113) as measured by RECIST
1.1 (Response Evaluation Criteria in Solid Tumors). Based on the ≥1
percent cut-point, responses were observed in 49 percent [95% CI;
range 38-61] (n=83) (per RECIST criteria) of patients with positive
PD-L1 tumors and 13 percent [95% CI; range 4-31] (n=30) of patients
with PD-L1 negative tumors. When the ≥10 percent cut-point was
used, responses were observed in 52 percent [95% CI; range 40-65]
(n=65) of patients with PD-L1 positive tumors and 23 percent [95%
CI; range 12-37] (n=48) of patients with PD-L1 negative tumors.
The high prevalence of PD-L1 expression, along with the
responses observed in the overall population and patients with
PD-L1 positive tumors based on the ≥1 percent cut-point, suggest
that selecting patients for MK-3475 therapy based on measurement of
PD-L1 is of limited utility in this tumor. Preliminary findings for
overall disease control rates, median estimated progression-free
survival (PFS), and median estimated overall survival (OS) were
also presented.
Preliminary PD-L1 Expression Analysis in Advanced
NSCLC
Preliminary findings on PD-L1 expression in 129 evaluable
previously-treated patients with advanced NSCLC, based on a minimum
of 19-week follow-up from the ongoing KEYNOTE-001 study, were
presented by Dr. Leena Gandhi, assistant professor of medicine at
Harvard Medical School and thoracic oncologist at Dana-Farber
Cancer Institute (abstract #5014). Results from the preliminary
analysis showed that approximately 45 percent of advanced NSCLC
patients had positive PD-L1 tumors at a cut-point of ≥1 percent of
tumor cells stained as defined by IHC assessment. Based on this
data set, the preliminary analysis suggests that the optimal
cut-point is ≥50 percent of tumor cells stained by IHC assessment.
When using this measurement, approximately 25 percent of advanced
NSCLC patients had tumors that strongly expressed PD-L1.
In the overall evaluable advanced NSCLC population, the overall
response rate was 19 percent (n=129) (per RECIST criteria). In
evaluable PD-L1-positive strong expresser population, responses
were seen in 37 percent [95% CI; range 22-53] (n=15/41) (per RECIST
criteria) of these patients, with responses also observed in 11
percent [95% CI; range 6-20] (n=10/88) of patients with PD-L1 low
or negative tumors. When the ≥1 percent cut-point was used,
responses were observed in 25 percent [95% CI; range 17-36]
(n=22/87) of evaluable patients with PD-L1 positive tumors and 7
percent [95% CI; range 2-20] (n=3/42) of patients with PD-L1
negative tumors. Preliminary data on estimated median PFS and
estimated median OS were also presented.
No adverse events were presented as part of these exploratory
analyses and were consistent with those previously reported for
MK-3475.
Additional Merck Oncology Data Presentations at AACR
2014
Additional Merck research presented at AACR include the
following abstracts (presented as posters on Wednesday, April
9):
- mDX400, the murine analog against
MK-3475 is active in immunocompetent, autochthonous murine models
of melanoma and breast cancer (Abstract #5024)
- Dissecting the dynamics of anti-PD1
immunotherapy in preclinical tumor models (Abstract #5025)
About MK-3475
Many tumors are able to evade the immune system through a
mechanism that exploits the PD-1 inhibitory checkpoint protein.
MK-3475 is an investigational, highly selective anti-PD-1
immunotherapy designed to restore the ability of the immune system
to recognize and target cancer cells by selectively achieving dual
ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking
PD-1, MK-3475 enables activation of the immune system’s T-cells
that target cancer, essentially by releasing a brake on the immune
system.
MK-3475 is being studied in 15 clinical trials estimated to
enroll more than 4,000 patients across more than 30 types of
cancer. Additional trials, both as monotherapy and in combination
with other cancer therapies, are planned. For information on
ongoing MK-3475 clinical trials please visit
http://www.merck.com/clinical-trials .
Merck announced Breakthrough Therapy designation for MK-3475 in
advanced melanoma by the U.S. Food and Drug Administration in April
2013. Merck announced in January the initiation of a rolling
submission of a Biologics License Application for MK-3475 in
advanced melanoma in the U.S. The company expects to complete the
submission in the first half of 2014.
About Advanced Melanoma
There were an estimated 232,000 new cases of melanoma diagnosed
in 2012 worldwide. Melanoma is the most dangerous type of skin
cancer and is the leading cause of death from skin disease. While
it accounts for only five percent of all cases, melanoma is the
cause of the vast majority of skin cancer deaths. According to the
American Cancer Society, an estimated 9,480 people in the U.S. died
from advanced melanoma in 2013.
About Lung Cancer
Lung cancer is the leading cause of cancer death worldwide in
both men and women, with an estimated 1.5 million deaths worldwide
each year, according to the American Cancer Society. NSCLC is the
most common type of lung cancer representing about 85 percent of
all lung cancer diagnoses.
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 and connect with us on Twitter, Facebook and
YouTube.
Merck 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).
Media:Ian McConnell, 973-901-5722Claire Mulhearn,
908-423-7425orInvestors:Carol Ferguson, 908-423-4465Justin Holko,
908-423-5088
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