| CHICAGO, June 1
CHICAGO, June 1 Data from a pivotal trial of
Amgen Inc's experimental melanoma therapy shows that it
improved survival by 21 percent for patients with advanced forms
of the deadly skin cancer compared with a standard white blood
Final survival results are not expected until later this
year, but Wall Street has been awaiting the interim trial
details to help assess the drug's commercial potential within a
new market of promising melanoma treatments.
RBC Capital Markets analyst Michael Yee said recently that
the Amgen drug - talimogene laherparepvec, or T-Vec - will
ultimately need to demonstrate that it improves overall survival
by more than 15 percent.
T-Vec is an engineered virus designed to be injected into
tumors, where it replicates until membranes of the cancer cells
rupture and die. The drug is then expected to activate a
systemic immune response to kill tumor cells throughout the
Other new drugs in the field include "immunotherapies," such
as Yervoy from Bristol-Myers Squibb, which is designed
to harness the body's immune system to fight the skin cancer.
Amgen had said in March that the trial met its main goal of
showing that T-Vec shrank tumors for at least six months in
significantly more patients, 16 percent, than a comparison
treatment, where the so-called durable response rate was 2
Other new details of the trial, presented on Saturday at the
annual meeting of the American Society of Clinical Oncology,
included an overall T-Vec response rate, meaning tumor shrinkage
without the six-month requirement, of 26 percent. That compares
with 6 percent for patients treated with GM-CSF, a type of white
blood cell-booster. Eleven percent of T-Vec patients had their
The trial also showed that patients with earlier-stage
disease had the highest rates of durable response. That rate was
33 percent for stage III patients, compared with 8 percent for
patients with the most advanced cancer.
David Chang, head of global oncology development at Amgen,
said the company is currently in discussions with the U.S. Food
and Drug Administration about how to move forward and seek
regulatory approval. Melanoma is diagnosed in about 132,000
people worldwide each year.
He also said the company is interested in testing its drug
in combination with Yervoy and other new melanoma therapies.
The most common side effects seen in the trial of over 400
patients were mild flu-like symptoms.
Chang said Amgen is still evaluating whether to study T-Vec
as a treatment for other types of cancer.