THOUSAND OAKS, Calif. (
) -- An experimental drug from
(AMGN - Get Report)
helped women with recurrent ovarian cancer extend the time before their disease worsened, according to results from a late-stage study announced Wednesday.
The Amgen drug, known as trebananib or AMG 386, has not yet helped ovarian cancer patients live longer, which may hamper efforts to get the drug approved in the U.S.
has been unable to secure an expanded FDA approval for its blockbuster drug Avastin in ovarian cancer because studies have failed to demonstrate a survival benefit. Avastin is approved for ovarian cancer in Europe based on studies demonstrating a delay in the tumor progression.
In the Amgen study known as "Trinova-1" more than 900 women with recurrent ovarian cancer were randomized to receive trebananib plus the chemotherapy drug paclitaxel or paclitaxel plus a placebo.
Patients treated in the trebananib arm saw a 34 percent reduction in the risk of disease progression or death compared to the placebo arm. The result was statistically significant and met the primary endpoint of the study.
The study continues to follow patients for overall survival, with results expected next year. On Tuesday, Amgen noted an "early imbalance of deaths" that favored patients in the placebo arm but that the overall survival trend favored trebananib, according to a pre-planned interim analysis.
In the trebananib arm, the most frequently reported adverse events were localized swelling, nausea and hair loss. Twenty percent of trebananib-trewated patients discontinued from the study due to adverse events compared to 7 percent in the placebo arm.
Amgen is conducting two more phase III studies of trebananib in ovarian cancer which combine the drug with different combinations of chemotherapy.
With all the caveats and dangers of comparing drugs across different clinical trials, the trebananib results announced Wednesday by Amgen fall short of what Roche has previously presented from studies of Avastin in ovarian cancer.
In 2011, a
study of Avastin plus chemotherapy reduced the risk of disease progression
by 52% compared to chemotherapy alone. The survival trend also favored Avastin but was not statistically significant. Roche was able to use these data (and others) to secure European approval of Avastin in ovarian cancer but the company chose not to file for approval in the U.S.
Amgen licensed trebananib from
(DYAX - Get Report)
. The drug is also being studied as a potential treatment for kidney, breast, liver and lung cancer.
Amgen shares were up 26 cents to $98.19 in Wednesday trading.
-- Reported by Adam Feuerstein in Boston.