Amgen Provides Update On Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic Melanoma

Amgen Provides Update On Phase 3 Study Of Talimogene Laherparepvec In Patients
                           With Metastatic Melanoma

PR Newswire

THOUSAND OAKS, Calif., April 4, 2014

THOUSAND OAKS, Calif., April 4, 2014 /PRNewswire/ --Amgen (NASDAQ: AMGN)
today announced top-line results from the primary overall survival (OS)
analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and
safety of talimogene laherparepvec for the treatment of unresected stage IIIB,
IIIC or IV melanoma compared to treatment with subcutaneous
granulocyte-macrophage colony-stimulating factor (GM-CSF). Results showed
that, while the primary end point of durable response rate was met (as
previously reported), the secondary endpoint of OS was not met, although there
was a strong trend in favor of talimogene laherparepvec (p=0.051). The
estimated OS hazard ratio and improvement in median OS were similar to what
was previously reported at the interim OS analysis.

Talimogene laherparepvec is an investigational oncolytic immunotherapy
designed to selectively replicate in tumors and to initiate an immune response
to target cancer that has metastasized, or spread to other areas of the body.

"We remain encouraged that the study met its primary endpoint of achieving
durable responses in patients with metastatic melanoma," said Sean E. Harper,
M.D., executive vice president of Research and Development at Amgen. "We
missed statistical significance on the secondary endpoint of overall survival
but the strong trend in survival benefit supports further research of
talimogene laherparepvec to better understand its role in melanoma, both as a
single-agent and in combination with other therapies."

The global, randomized, open-label Phase 3 trial enrolled patients with
unresected stage IIIB, IIIC or IV melanoma. Patients were randomized 2:1 to
receive either talimogene laherparepvec every two weeks through direct tumor
injection or GM-CSF subcutaneously for the first 14 days of each 28-day cycle,
for up to 18 months.

The most frequent adverse events observed in this trial were fatigue, chills
and pyrexia. The most common serious adverse events include disease
progression, cellulitis and pyrexia.

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.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.

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 thanfive 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 tumor

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Wendy Woods Williams, 805-447-6382  (media)
Arvind Sood, 805-447-1060 (investors)


^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 Accessed
February 21, 2014.

^2 Ultraviolet radiation and the INTERSUN Programme.World Health
Organization. AccessedFebruary
21, 2014.^

^3American Cancer Society. Melanoma Skin
AccessedFebruary 21, 2014.

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