This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Amgen Drug Delays Ovarian Cancer Re-Growth, Survival Benefit Unclear

Stocks in this article: AMGN DYAX RHHBY

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.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

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.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs