* AMG 386 progression-free survival 7.2 mos vs 4.6 mos
* Shows promising evidence of anti-tumor activity
* Researchers say safety profile manageable
By Bill Berkrot
NEW YORK, May 20 An experimental drug being
developed by Amgen Inc (AMGN.O) appeared to keep recurrent
ovarian cancer in check longer when combined with chemotherapy
than chemotherapy alone, according to a summary of data from a
The 161-patient study tested Amgen's AMG 386 at two doses
in combination with the chemotherapy drug paclitaxel against
chemotherapy alone, with the higher dose demonstrating the
better response, data from an abstract of the study showed.
The primary goal of the Phase II study was the time it took
for the disease to worsen in half the patients in each
treatment group -- a measure known as median progression-free
survival. Patients were given the drugs until the disease
progressed or the medicines caused unacceptable toxicity.
Patients who got the higher dose of AMG 386 -- 10
milligrams per kilogram of body weight -- had median
progression-free survival of 7.2 months, compared with 5.7
months in those who received 3mg/kg of AMG 386.
Those who received only paclitaxel had median
progression-free survival of 4.6 months.
Full data from the study will be presented next month at
the American Society of Clinical Oncology scientific meeting in
Chicago. ASCO on Thursday released thousands of abstracts, or
brief summaries, of studies to be presented next month at the
year's most important cancer meeting.
AMG 386 is an anti-angiogenesis drug, which means it
inhibits the growth of blood vessels needed to feed a tumor.
Adverse side effects seen with the drug included peripheral
edema, or swelling of lower limbs, low levels of potassium in
the blood and blood clots.
Researchers concluded that the safety profile was
manageable and that AMG 386 showed promising anti-tumor
activity with a more pronounced effect at the higher dose.
(Reporting by Bill Berkrot; editing by Carol Bishopric)