Amgen drug extends survival in ovarian cancer study
* AMG 386 extends survival 1.6 mos vs chemotherapy alone
* Amgen has launched Phase 3 trial
LOS ANGELES Oct 9 (Reuters) – A mid-stage trial of an experimental drug being developed by Amgen Inc (AMGN.O) found that it can extend survival by several weeks for women with advanced ovarian cancer when combined with chemotherapy.
The 161-patient Phase 2 study found that patients treated with the higher dose of the drug, called AMG 386, lived for a median of 22.5 months, compared with 20.4 months for those given a lower dose of the drug, and 20.9 months for patients who received only the chemotherapy drug paclitaxel.
Amgen said it has begun a Phase 3 of the drug, in combination with paclitaxel, as a treatment for ovarian, primary peritoneal, and fallopian tube cancers.
The main goal of the Phase 2 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 who got the higher dose of AMG 386 had median progression-free survival of 7.3 months, compared with 7.4 months in those who received a lower dose and 5 months for those who received only paclitaxel.
Earlier results reported in June had shown progression-free survival of 7.2 months for the high dose, 5.7 months for the lower dose and 4.6 months for chemotherapy alone.
The updated results were reported at a medical meeting in Milan, Italy on Saturday.
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 neuropathy, low levels of potassium in the blood and blood clots.
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