Amgen drug shows promise in ovarian cancer

Thu May 20, 2010 6:52pm EDT

* 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 (Reuters) - 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 mid-stage study.

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)


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