THOUSAND OAKS, Calif.,
Dec. 8, 2014 /PRNewswire/ -- Amgen
(NASDAQ: AMGN) today announced the initiation of a trial of
talimogene laherparepvec, an investigational oncolytic
immunotherapy, in combination with an investigational use of
Merck's U.S. Food and Drug Administration (FDA) approved, anti-PD-1
therapy, KEYTRUDA® (pembrolizumab) in patients
with regionally or distantly metastatic melanoma. The trial has
enrolled its first patient and will evaluate the combination of
these two therapies in approximately 110 patients across 35
clinical trial sites in the U.S., Australia and Europe.
"Data from this trial will help us further understand the safety
and efficacy that comes from combining two
immunotherapeutic agents," said F.
Stephen Hodi, M.D., director of the Melanoma Center
and the Center for Immuno-Oncology at Dana-Farber Cancer
Institute and Steering Committee Chair for this
study. "Talimogene laherparepvec is designed to promote
tumor antigen release and presentation to initiate an anti-tumor
immune response, which may be complementary to KEYTRUDA's role in
releasing PD-1 pathway-mediated inhibition of anti-tumor immune
responses. Antigen release and presentation is a fundamental step
required for mounting a systemic effect against melanoma, and we
think there is a strong rationale for combining the oncolytic
immunotherapy talimogene laherparepvec with the immune checkpoint
inhibitor KEYTRUDA."
"This new trial underscores our commitment to researching
different treatment approaches for patients with this aggressive
and highly recurrent form of skin cancer," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "We are excited to
partner with Merck and explore the potential of talimogene
laherparepvec and KEYTRUDA. This will also give us insights
into talimogene laherparepvec beyond the monotherapy setting, where
a Phase 3 trial has shown encouraging results."
"Merck is advancing the study of immuno-oncology combinations
with KEYTRUDA across a broad range of malignancies," said Dr.
Eric Rubin, vice president, Clinical
Development for Oncology, Merck Research Laboratories. "We are
pleased to collaborate with Amgen to evaluate the potential of
KEYTRUDA and talimogene laherparepvec as a combination regimen for
the treatment of advanced melanoma."
A Biologics License Application has recently been accepted for
review by the FDA as has a Marketing Authorization Application
in the European Union for talimogene laherparepvec for
the treatment of patients with regionally or distantly metastatic
melanoma. FDA has set a review goal date under the
Prescription Drug User Fee Act (PDUFA) of July 28,
2015.
The regulatory filings included data from more than 400 patients
and is based on a global, randomized, open-label Phase 3 trial
evaluating the safety and efficacy of intralesional talimogene
laherparepvec in patients with stage IIIB, IIIC, or IV melanoma
that are not surgically resectable compared to
granulocyte-macrophage colony-stimulating factor (GM-CSF). An
Amgen-sponsored expanded access protocol (EAP) is currently active
for qualified patients with unresected, stage IIIB to IV melanoma
who are not eligible for or who cannot access ongoing talimogene
laherparepvec trials.
About the Combination Trial
The multicenter,
open-label clinical trial is designed to evaluate the safety of
talimogene laherparepvec in combination with KEYTRUDA, as well as
the efficacy of this combination versus KEYTRUDA alone and
following progression after treatment with KEYTRUDA alone.
The study will be conducted in two phases:
- Phase 1 will determine the safety and tolerability of
talimogene laherparepvec in combination with KEYTRUDA in patients
with previously untreated, unresected, stage IIIB to IVM1c
melanoma.
- The randomized phase will further evaluate the safety and
efficacy of talimogene laherparepvec in combination with
KEYTRUDA.
About Talimogene Laherparepvec
Talimogene
laherparepvec is an investigational oncolytic immunotherapy
designed to selectively replicate in tumors (but not normal tissue)
and to initiate an immune response to target cancer cells that have
metastasized. Talimogene laherparepvec was designed to work in two
important and complementary ways. First, it is injected directly
into tumors where it replicates inside the tumor's cells causing
the cell to rupture and die in a process called lysis. Then, the
rupture of the cancer cells can release tumor-derived antigens,
along with GM-CSF, that can stimulate a system-wide immune response
where white blood cells are able to seek out and target cancer that
has spread throughout the body.
Amgen has initiated a comprehensive clinical development program
for talimogene laherparepvec in metastatic melanoma, which includes
combination studies with checkpoint inhibitors in patients with
late-stage disease and monotherapy prior to surgery (neoadjuvant)
in patients with resectable disease. Additionally, based on its
mechanism of action, talimogene laherparepvec has the potential to
be studied in a variety of solid tumor types.
Access to Investigational Medicines
To serve
patients, Amgen engages in clinical research with the goal of
obtaining regulatory approval of its products. Clinical trials
allow Amgen to evaluate investigational new treatments in
volunteers in order to generate the safety and efficacy information
needed to obtain approval of those treatments and make them
available to the broader patient population. Outside of a clinical
trial, access to Amgen's investigational products would be
considered under limited circumstances and as permitted by
applicable law. More information can be found here on the Amgen
website.
About Melanoma
Melanoma is a type of skin cancer that
is characterized by the uncontrolled growth of melanocytes, which
are the cells responsible for providing the pigment to
skin.1 Melanoma is the most aggressive and serious
form of skin cancer. Currently, 132,000 melanoma cases occur
globally each year.2 In the U.S., while melanoma
accounts for less than five percent of skin cancer cases, it causes
the most skin cancer deaths.3 The number of new
cases of melanoma in the U.S. has been increasing for the last 30
years.3
Melanoma is considered to be advanced when it has spread, or
metastasized, from the origin site to deeper parts of the skin or
other organs such as the lymph nodes, lungs or other parts of the
body distant from the primary tumor site.4
About Amgen
Amgen is committed to
unlocking the potential of biology for patients suffering from
serious illnesses by discovering, developing, manufacturing and
delivering innovative human therapeutics. This approach begins by
using tools like advanced human genetics to unravel the
complexities of disease and understand the fundamentals of human
biology.
Amgen focuses on areas of high unmet medical need and
leverages its biologics manufacturing expertise to strive for
solutions that improve health outcomes and dramatically improve
people's lives. A biotechnology pioneer since
1980, Amgen has grown to be the world's largest
independent biotechnology company, has reached millions of patients
around the world and is developing a pipeline of medicines with
breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains
forward-looking statements that are based on the current
expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen,
we or us) and are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially
from those described. All statements, other than statements of
historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission (SEC) reports filed by Amgen Inc., including Amgen
Inc.'s most recent annual report on Form 10-K and any subsequent
periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen
Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional
information on the uncertainties and risk factors related to our
business. Unless otherwise noted, Amgen is providing this
information as of Dec. 8, 2014, and
expressly disclaims any duty to update information contained in
this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
and our partners to complete clinical trials and obtain regulatory
approval for product marketing has in the past varied and we expect
similar variability in the future. We develop product candidates
internally and through licensing collaborations, partnerships and
joint ventures. Product candidates that are derived from
relationships may be subject to disputes between the parties or may
prove to be not as effective or as safe as we may have believed at
the time of entering into such relationship. Also, we or others
could identify safety, side effects or manufacturing problems with
our products after they are on the market. Our business may be
impacted by government investigations, litigation and product
liability claims. If we fail to meet the compliance obligations in
the corporate integrity agreement between us and the U.S.
government, we could become subject to significant sanctions. We
depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products (including products of our
wholly-owned subsidiaries) are affected by the reimbursement
policies imposed by third-party payers, including governments,
private insurance plans and managed care providers and may be
affected by regulatory, clinical and guideline developments and
domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we and
our partners routinely obtain patents for our and their products
and technology, the protection of our products offered by patents
and patent applications may be challenged, invalidated or
circumvented by our or our partners' competitors and there can be
no guarantee of our or our partners' ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
business and results of operations. Our efforts to integrate the
operations of companies we have acquired may not be successful.
Cost savings initiatives may result in us incurring impairment or
other related charges on our assets. We may experience
difficulties, delays or unexpected costs and not achieve
anticipated benefits and savings from our recently announced
restructuring plans. Our business performance could affect or limit
the ability of our Board of Directors to declare a dividend or our
ability to pay a dividend or repurchase common stock.
The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates.
CONTACT: Amgen Thousand Oaks
Kristen Davis,
805-447-3008 (media)
Arvind Sood, 805-447-1060
(investors)
References:
1. National Cancer
Institute, National Institute of Health, U.S. Dept. of
Health and Human Services. What You Need to Know
About Melanoma and Other Skin Cancers. June
2010.http://www.cancer.gov/cancertopics/wyntk/skin.
Accessed July 18, 2014.
2. World Health Organization. Ultraviolet radiation and the
INTERSUN
Programme. http://www.who.int/uv/faq/skincancer/en/index1.html.
Accessed July 18, 2014.
3. Melanoma skin cancer overview. American Cancer Society website.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003063-pdf.pdf
Accessed July 18, 2014.
4. American Cancer Society. Melanoma Skin
Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf
Accessed July 18, 2014.
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