Amgen Announces Top-Line Results Of Phase 3 Talimogene Laherparepvec Trial In Melanoma

Amgen Announces Top-Line Results Of Phase 3 Talimogene Laherparepvec Trial In

PR Newswire

THOUSAND OAKS, Calif., March 19, 2013

THOUSAND OAKS, Calif., March 19, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN)
today announced top-line results from the Phase 3 trial in melanoma, which
evaluated the efficacy and safety of talimogene laherparepvec for the
treatment of unresected stage IIIB, IIICor IV melanoma compared to treatment
with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

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: 16 percent
in the talimogene laherparepvec arm versus two percent in the GM-CSF arm. The
analysis of overall survival (OS), a key secondary endpoint of the study, is
event driven. A pre-planned interim analysis conducted with the analysis of
DRR has shown an OS trend in favor of talimogene laherparepvec as compared to
GM-CSF. The OS data is expected to mature in late 2013 in line with previous

"These are the first Phase 3 results of this novel approach to cancer
therapy," said Sean E. Harper, M.D., executive vice president of Research and
Development at Amgen. "A high unmet need exists in melanoma and we believe the
innovative mechanism of action of talimogene laherparepvec may offer a
promising approach for these patients."

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.

Among the various types of skin cancer, melanoma is the most aggressive and
also the most serious. Although melanoma accounts for less than five percent
of skin cancer cases, or 132,000 cases globally each year, melanoma accounts
for 75 percent of all skin cancer deaths.[i]

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

Additional safety and efficacy data will be submitted to the American Society
of Clinical Oncology (ASCO) for the 2013 Annual Meeting.

Trial Design (NCT00769704)
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 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 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 millions of people around the world
in the fight against cancer, kidney disease, rheumatoid arthritis, bone
disease and other serious illnesses. With a deep and broad pipeline of
potential new medicines, Amgen remains committed to advancing science to
dramatically improve people's lives. To learn more about our pioneering
science and vital medicines, visit Follow us on

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[i] Skin Cancers. World Health Organization, Accessed March 8, 2013.


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