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
The most common serious adverse events observed in the trial include
disease progression, a bacterial skin infection and fever, the
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 therapy.
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 cell-boosting
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 patients.
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.
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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 cases.
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 on Thursday.
(Reporting by Vrinda Manocha in Bangalore;
editing by Simon
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