This Day On The Street
Continue to site
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

Aveo Beats Onyx in Study of Dueling Kidney Cancer Drugs But Shares Still Fall

Content on this page requires a newer version of Adobe Flash Player.

Get Adobe Flash player

Updated with new analysis and stock price information.

CAMBRIDGE, Mass. ( TheStreet) -- An experimental drug from Aveo Pharmaceuticals (AVEO - Get Report) delayed tumor growth in patients with advanced kidney cancer more effectively than Onyx Pharmaceuticals' (ONXX) currently approved drug Nexavar, according to results from a late-stage study released Tuesday.

Aveo shares dropped in early trading, however, on concerns that the clinical benefit of tivozanib may not be as robust as expected. Aveo shares are down 13% to $14.95 in Tuesday pre-market trading. The stock closed 2011 at $17.20.

Aveo said it plans to seek U.S. approval for its kidney cancer drug tivozanib this year. The roughly $2 billion worldwide kidney cancer drug market is crowded, but Aveo is hoping that tivozanib can grab valuable share from Onyx and even market leader Pfizer (PFE) based on the positive results from the phase III study.

Tuesday's phase III study, dubbed TIVO-1, was somewhat unusual in that it pitted the experimental tivozanib head-to-head against Onyx's Nexavar. Testing an experimental drug against an active comparator rather than a placebo can be a risky proposition, but for Aveo, the bet paid off.

Treatment with tivozanib delayed the progression of cancer by a median of 11.9 months compared to a median 9.1 months for Nexavar. Both numerically and statistically, the results from TIVO-1 demonstrated that tivozanib was superior to Nexavar, Aveo said. The study enrolled 517 patients with advanced kidney cancer.

In the pre-specified subgroup of kidney cancer patients previously untreated with drugs, treatment with tivozanib delayed tumor progression by a median 12.7 months compared to 9.1 months for Nexavar.

While the TIVO-1 study met its primary endpoint, the roughly three-month difference in clinical benefit between tivozanib and Nexavar was relatively small and shorter than expected, largely because Nexavar performed better than it has in previous clinical studies.

Tivozanib, Nexavar and Pfizer's Sutent are all oral drugs that turn off the same signaling pathway cancers use to grow. Aveo developed tivozanib to be more selective in its ability to target and turn off this key cancer growth pathway.

Aveo chose not to test tivozanib directly against Sutent but the 11.9-month delay in tumor progression observed in TIVO-1 tops the 11 months demonstrated by Sutent in its separate pivotal study.

Sutent is currently the most prescribed therapy for advanced kidney cancer patients. Whether or not doctors reach for tivozanib over Sutent may depend largely on the relative safety and tolerability of the two drugs. Previous studies have shown tivozanib to have a more benign side effect profile than Sutent.

Last February, Aveo licensed global marketing rights to tivozanib to Japanese drugmaker Astellas.

--Written by Adam Feuerstein in Boston.

>To contact the writer of this article, click here: Adam Feuerstein.

>To follow the writer on Twitter, go to

>To submit a news tip, send an email to:

Follow TheStreet on Twitter and become a fan on Facebook.
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.

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
ONXX $0.00 0.00%
AVEO $1.19 0.00%
AAPL $118.30 0.00%
FB $104.60 0.35%
GOOG $742.60 0.00%


Chart of I:DJI
DOW 17,719.92 -78.57 -0.44%
S&P 500 2,080.41 -9.70 -0.46%
NASDAQ 5,108.6660 -18.8590 -0.37%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs