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Amgen Presents Positive Results From Talimogene Laherparepvec Phase 3 Study In Patients With Metastatic Melanoma



Amgen Presents Positive Results From Talimogene Laherparepvec Phase 3 Study In
                      Patients With Metastatic Melanoma

PR Newswire

THOUSAND OAKS, Calif., June 1, 2013

THOUSAND OAKS, Calif., June 1, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today
announced detailed results from a pivotal Phase 3 trial evaluating talimogene
laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma
compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). The
results will be presented as an oral presentation at the 2013 American Society
of Clinical Oncology (ASCO) Annual Meeting (Abstract No. LBA9008). 

The study met its primary endpoint of durable response rate (DRR), defined as
the rate of complete or partial response lasting continuously for at least six
months. A statistically significant difference was observed in DRR with 16
percent in the talimogene laherparepvec arm versus two percent in the GM-CSF
arm (95 percent CI, 12-21 percent, versus 95 percent CI, 0-5 percent,
p<0.0001). The overall response rate was 26 percent with talimogene
laherparepvec as compared to six percent for GM-CSF.  A trend toward overall
survival (HR = 0.79, 95 percent CI, 0.61-1.02) was also observed at a
predefined interim analysis.

"These are the first data from a controlled trial of oncolytic immunotherapy
to demonstrate activity in melanoma," said Sean E. Harper, M.D., executive
vice president of Research and Development at Amgen. "We are pleased with the
results of this pivotal Phase 3 trial for talimogene laherparepvec and we look
forward to the mature overall survival data later this year."

In regionally and distantly metastatic melanoma (stages III and IV), cancer
has spread to skin, lymph nodes, or to other organs distant from the site of
origin. The DRR was highest among patients with stage III and stage IVM1a
disease. The observed DRR for talimogene laherparepvec were: 33 percent in
stage IIIB/IIlC, 16 percent in stage IVM1a, and three and eight percent
respectively for stages IVM1b and IVM1c. The DRR with GM-CSF was not higher
than four percent in any of the stage subsets.

"Over the last 30 years, the incidence of metastatic melanoma has increased by
over 200 percent, so there is a need for new treatment options," said study
author Robert Andtbacka, M.D., assistant professor, University of Utah
Huntsman Cancer Institute. "The results of this study are encouraging in a
disease as devastating as metastatic melanoma."

The most frequently observed adverse events were fatigue, chills and pyrexia.
The most common serious adverse events include disease progression, cellulitis
and pyrexia. Serious adverse events occurred in 26 percent of talimogene
laherparepvec patients and 13 percent of GM-CSF patients.

Talimogene laherparepvec is an investigational oncolytic immunotherapy
designed to work in two important and complementary ways – causing local lytic
destruction of tumors while also stimulating a systemic anti-tumor immune
response. 

Full results will be presented today at the 2013 ASCO Annual Meeting at the
Melanoma/Skin Cancers session on Saturday, June 1, 3:45 p.m. CDT, S406
(Abstract No. LBA9008).

Trial Design

This trial was a global, randomized, open-label, Phase 3 trial 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 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
United States, while melanoma accounts for less than five percent of skin
cancer cases, it causes the most skin cancer deaths.^2 The number of new cases
of melanoma in the U.S. has been increasing for the last 30 years.^2 

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 lesion
site.^3

About Talimogene Laherparepvec

Talimogene laherparepvec is an investigational oncolytic immunotherapy
designed to selectively replicate in tumor tissue. Talimogene laherparepvec is
injected directly into tumor tissue and then replicates until the membrane of
the cancer cells rupture, thereby destroying the cells, in a process known as
cell lysis. The virus that was contained in these cells is then released
locally in the tumor tissue along with GM-CSF, a white blood cell growth
factor that the virus is engineered to express. This is intended to lead to
the activation of a systemic immune response to kill tumor cells throughout
the body.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe, effective
medicines from lab to manufacturing plant to patient. Amgen therapeutics have
changed the practice of medicine, helping people around the world in the fight
against serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically
improve people's lives. 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
management's current expectations and beliefs 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, including Amgen'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'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 June 1, 2013, 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 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
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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
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In addition, sales of our products are affected by the reimbursement policies
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and managed care providers and may be affected by regulatory, clinical and
guideline developments and domestic and international trends toward managed
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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 routinely obtain patents for our products and technology,
the protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and there can be no
guarantee of our 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.

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 (FDA), and no
conclusions can or should be drawn regarding the safety or effectiveness of
the product candidates.  Only the FDA can determine whether the product
candidates are safe and effective for the use(s) being investigated.
Healthcare professionals should refer to and rely upon the FDA-approved
labeling for the products, and not the information discussed in this news
release.

CONTACT: Amgen, Thousand Oaks
Ashleigh Koss, 805-559-0746 (media)
Arvind Sood, 805-447-1060 (investors)

References:

^1 National Cancer Institute, National Institute of Health, Dept. of Health
and Human Services; What You Need to Know About Melanoma and Other Skin
Cancers; June 2010.

^2 Ultraviolet radiation and the INTERSUN Programme. World Health
Organization. http://www.who.int/uv/faq/skincancer/en/index1.html. Accessed
May 13, 2013. ^ 

^3 Melanoma Skin Cancer, American Cancer Society,
http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf.
Accessed May 13, 2013.

(Logo:  http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

SOURCE Amgen

Website: http://www.amgen.com
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