Amgen Presents Interim Overall Survival Data From Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic

Amgen Presents Interim Overall Survival Data From Phase 3 Study Of Talimogene
              Laherparepvec In Patients With Metastatic Melanoma

PR Newswire

THOUSAND OAKS, Calif., Nov. 18, 2013

THOUSAND OAKS, Calif., Nov. 18, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced interim overall survival (OS) 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). Results will be presented today during an oral session at the
2013 Society for Melanoma Research (SMR) Congress, in Philadelphia. 

At a predefined interim analysis of this Phase 3 study, median OS was 23.3
months in the talimogene laherparepvec arm over 19.0 months in the GM-CSF arm
(HR = 0.79, 95 percent CI 0.61-1.02; p=0.0746). Differences in survival rates
were pronounced in the subset of patients with stage IIIB, IIIC or IV M1a
disease (HR = 0.56, 95 percent CI, 0.38-0.81) or who received talimogene
laherparepvec asfirst-line treatment (HR = 0.49, 95 percent CI, 0.33-0.74),
each comprising approximately 50 percent of the study population.

"The interim overall survival subset results complement the durable response
data we reported earlier this year and these endpoints appear to correlate
with each other in terms of where the most benefit is being seen in this
trial," said Sean E. Harper, M.D., executive vice president of Research and
Development at Amgen. "We look forward to the mature overall survival data
expected in the first half of next year."

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

"A favorable trend in overall survival was observed in patients who received
talimogene laherparepvec and the trend was pronounced in patients with stage
III and IV M1a disease where an important clinical need exists for patients
whose disease has not yet spread to distant organs," said Howard Kaufman,
M.D., professor and director of the section of surgical oncology in the
Department of General Surgery, Rush University Medical Center in Chicago. "I
look forward to seeing the final results next year."

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 14days
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 pigment
to the skin.^1 Melanoma is the most aggressive and serious form of skin cancer
in which the best treatment approach involves early detection.^2 Because it is
not always possible to detect cancer in its earlier stage, it can sometimes
spread, or metastasize,to other parts of the body.^3 The prevalence of
metastatic melanoma patients facing recurrence from an earlier stage of
disease is predicted to increase by 43 percent by 2015.^4 Metastatic melanoma
remains a devastating and difficult-to-treat disease with a high unmet need.

Currently, 132,000 melanoma cases occur globally each year.^5 In the United
States (U.S.), while melanoma accounts for less than five percent of skin
cancer cases, it causes the most skin cancer deaths.^5 The number of new cases
of melanoma in the U.S. has been increasing for the last 30 years.^5

About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy
designed to selectively replicate in tumor tissue and to initiate a systemic
anti-tumor immune response. Talimogene laherparepvec is injected directly into
tumor tissue and is intended to replicate preferentially in tumor cells
causing lytic cell death and releasing an array of tumor specific antigens.
Talimogene laherparepvec is also engineered to express GM-CSF, a white blood
cell growth factor that can help to activate the immune system. The aim of
this combination of actions is to induce a systemic anti-tumor immune response
that targets tumor cells throughout the body.

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
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
byAmgen, includingAmgen'smost recent annual report on Form 10-K and any
subsequent periodic reports on Form 10-Q and Form 8-K.Please refer to
Amgen'smost 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,Amgenis providing this information as ofNov. 18, 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
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The scientific information discussed in this news release related to our
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CONTACT: Amgen
Kristen Davis, 805-447-3008 (media)
Arvind Sood, 805-447-1060 (investors)

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

^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 American Cancer Society. Surgery for Metastatic Skin Cancer.
http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-treating-surgery.
Accessed August 28, 2013.^
^3 American Cancer Society. What is Metastatic Skin Cancer.
http://www.cancer.org/cancer/skincancer-melanoma/overviewguide/melanoma-skin-cancer-overview-what-is-melanoma.
Accessed August 28, 2013.^
^4 Lin AY, et al. Melanoma Res. 2012; 22:454-459
^5 Ultraviolet radiation and the INTERSUN Programme. World Health
Organization. http://www.who.int/uv/faq/skincancer/en/index1.html. Accessed
May 13, 2013.^

SOURCE Amgen

Website: http://www.amgen.com
 
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