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!

Aveo Pharma Readies Survival Update For Kidney Cancer Drug

CAMBRIDGE, Mass. (TheStreet) -- Aveo Pharmaceuticals (AVEO) will be presenting updated data on its kidney cancer drug tivozanib, including a more detailed look at overall survival, at a medical meeting next week. The new tivozanib data may help alleviate investor concerns about the drug's chance for FDA approval, although I suspect worries about tivozanib's commercial potential will linger.

Before Aveo can market tivozanib, FDA must approve, which is why the new data to be presented at the American Society of Clinical Oncology Genitourinary Symposium are important.

Embargoes on the new tivozanib data lift Tuesday, Feb. 12 at 6 pm, with the actual presentation scheduled for Feb. 16.

The most important presentation will be an update on two-year overall survival from the "TIVO-1" phase III study that compared tivozanib to Nexavar, marketed by Bayer and Onyx Pharmaceuticals (ONXX).

The only survival data presented previously from the study -- which has given Aveo headaches ever since -- showed one-year survival of 77% for tivozanib patients compared to 81% for Nexavar patients. The FDA raised concerns about this unfavorable survival trend, which naturally, set investors on edge.

At next week's ASCO GU meeting, we'll get more details on the final overall survival in both arms, including medians, the Kaplan-Meier curves, hazard ratio and p value. Certain patient subset analyses will also be presented.

Best case would be for the negative survival trend to reverse itself. Absent that (and I don't believe the survival benefit will tip in tivozanib's favor), the new data are more likely to address Aveo's argument that patient crossover skewed survival in Nexavar's favor.

What we know already is that more than 60% of the patients randomized to the Nexavar arm later received tivozanib or some other therapy upon tumor progression. These Nexavar crossover patients are living longer because they benefited from treatment with two active kidney cancer drugs, Aveo believes. Meantime, only 24% of patients chosen to begin the trial in the tivozanib arm went on to a subsequent therapy.

FDA is reviewing tivozanib with an approval decision date of July 28. An FDA advisory panel is expected to review the kidney cancer drug, although no date has been set. A May or June panel meeting is likely.

1 of 2

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!
DOW 17,039.49 +60.36 0.36%
S&P 500 1,992.37 +5.86 0.30%
NASDAQ 4,532.1040 +5.6220 0.12%

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