THOUSAND OAKS, Calif. (TheStreet) -- An experimental drug from Amgen (AMGN) 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.
Roche (RHHBY) 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 (DYAX). 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. Follow @AdamFeuerstein
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV