(Adds background, analyst comment)
April 4 Amgen Inc said its experimental
drug to treat a deadly form of skin cancer did not significantly
improve overall survival rates in patients enrolled in a
The company said the drug met the study's main goal of
shrinking tumors, as it had previously reported, but did not
meet the secondary goal of improving overall survival in
patients with melanoma.
The most common serious adverse events observed in the trial
include disease progression, a bacterial skin infection and
fever, the company said.
ISI Group analyst Mark Schoenebaum said the drug's failure
to significantly improve survival rates could affect its chances
for approval and limit its commercial opportunity as a single
Amgen said in June that data from the pivotal study showed
that the drug improved survival by 21 percent for patients with
advanced forms of melanoma compared with a standard white blood
The company first reported in March last year that the drug,
talimogene laherparepvec, met the study's main goal of inducing
a durable response rate (DRR) - defined as a complete or partial
tumor shrinkage lasting at least six months - in 16 percent of
Also known as T-Vec, the drug is injected directly into a
tumor and is designed to replicate until the cancer cells
rupture. It then activates the body's immune response to fight
cancer cells that have spread to other areas.
Amgen is also testing the drug in combination with
Bristol-Myers Squibb Co's melanoma drug Yervoy.
Skin cancer is the most common type of cancer in the United
States, but melanoma, which begins in skin cells that make the
pigment melanin, accounts for less than 2 percent of skin-cancer
The American Cancer Society estimates that 76,100 new cases
of melanoma will be diagnosed this year, and that the disease
will kill about 9,710 patients.
The company's shares were little changed at $122.20 in
morning trading on the Nasdaq on Friday. They closed at $124.13
(Reporting by Vrinda Manocha in Bangalore; Editing by Simon