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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

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

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

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 and follow
us on

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
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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
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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.

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materially from those we project.  Discovery or identification of new product
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CONTACT: Amgen, Thousand Oaks
Ashleigh Koss, 805-559-0746 (media)
Arvind Sood, 805-447-1060 (investors)


^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. Accessed
May 13, 2013. ^ 

^3 Melanoma Skin Cancer, American Cancer Society,
Accessed May 13, 2013.



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