THOUSAND OAKS, Calif.,
May 26, 2015 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced the publication of
primary results from the Phase 3 OPTiM study in the Journal of
Clinical Oncology (JCO). The data published in
JCO, which were previously presented at the Annual Meetings
of the American Society of Clinical Oncology (ASCO) in 2013 and
2014, demonstrated a significantly higher durable response rate
(DRR) in patients with unresected stage IIIB, IIIC or IV metastatic
melanoma receiving the investigational oncolytic immunotherapy
talimogene laherparepvec compared to those who received
granulocyte-macrophage colony-stimulating factor (GM-CSF). Results
showed that the primary endpoint of DRR was met, however the
secondary endpoint of overall survival (OS) was not met, although
there was a strong trend in favor of talimogene laherparepvec.
"Oncolytic virus immunotherapy may become a new approach to
melanoma treatment, and the OPTiM study demonstrated durable
responses in talimogene laherparepvec treated patients with
metastatic melanoma," said lead investigator Howard L. Kaufman, M.D., associate director for
Clinical Science at the Rutgers Cancer Institute of New Jersey and president of the Society for
Immunotherapy of Cancer. "Talimogene laherparepvec may offer a
potential new treatment option for patients with this aggressive
form of skin cancer."
A DRR measures the number of patients who had a complete
response or partial response within the first 12 months of
treatment and maintained the response continuously for at least
6 months.
The most frequent adverse events (AEs) observed in this study
were chills, pyrexia, injection-site pain, nausea, flu-like
symptoms and fatigue. The most common serious AEs included disease
progression, cellulitis and pyrexia. No treatment-related deaths
were observed.
"While there have been some important new treatment options in
recent years, the incidence of melanoma has risen dramatically, and
we need additional approaches for treating advanced disease," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "The OPTiM
trial data provide strong evidence supporting the local and distant
effects of talimogene laherparepvec and its potential to stimulate
a systemic anti-tumor immune response."
The OPTiM data serve as the basis of a Biologics License
Application which has been accepted for review by the U.S. Food and
Drug Administration (FDA), and a Marketing Authorization
Application in the European Union for talimogene
laherparepvec for the treatment of adults with regionally or
distantly metastatic melanoma. The FDA has set a review goal date
under the Prescription Drug User Fee Act of Oct. 27, 2015.
Trial Design
The OPTiM study was a global, randomized, open-label, Phase 3 trial
designed to evaluate the safety and efficacy of talimogene
laherparepvec compared to a control therapy with GM-CSF in over 400
patients with unresected stage IIIB, IIIC or IV melanoma.
Patients were randomized 2:1 to receive either talimogene
laherparepvec intralesionally every two weeks or GM-CSF
subcutaneously for the first 14 days of each 28 day cycle.
Treatment could last for up to 18 months. Where appropriate, stable
or responding patients could receive additional treatment on an
extension protocol.
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
clinical profile, talimogene laherparepvec has the potential to be
studied in a variety of solid tumor types.
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 one of the world's leading
independent biotechnology companies, 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 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 May 26, 2015, 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
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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
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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
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affected by regulatory, clinical and guideline developments and
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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
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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. We
may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our recently
announced restructuring plan. Our business performance could affect
or limit the ability of our Board of Directors to declare a
dividend or their ability to pay a dividend or repurchase our
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 February 26, 2015.
2. World Health Organization. Ultraviolet radiation and the
INTERSUN Programme.
http://www.who.int/uv/faq/skincancer/en/index1.html. Accessed
February 26, 2015.
3. Melanoma skin cancer overview. American Cancer Society website.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003063-pdf.pdf.
Accessed February 26, 2015
4. American Cancer Society. Melanoma Skin
Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf.
Accessed February 26, 2015
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