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
TheStreet Open House

Aveo Pharma: 'Crossover' Ate My Kidney Cancer Drug Survival Benefit

Stocks in this article: AVEO PFE ONXX GSK

Updated with stock price.

CAMBRIDGE, Mass. ( TheStreet) -- Final overall survival results from the phase III study of Aveo Pharmaceuticals' (AVEO - Get Report) kidney cancer drug tivozanib were released Tuesday night, and as expected, tivozanib-treated patients were at a greater risk of death than those treated with Onyx Pharmaceuticals' (ONXX) Nexavar.

At the median, the difference in survival was just two weeks. Tivozanib-treated patients reported a median overall survival of 28.8 months compared to 29.3 months for Nexavar patients.

However, when overall survival in the study was analyzed over two years, the relative risk of death was 25% higher in the tivozanib arm relative to the Nexavar arm. Hazard ratio = 1.245. While survival trended against tivozanib, the greater risk of death was not statistically significant.

Aveo has struggled for months to assuage investor concerns about the confounding results from the tivozanib study in advanced kidney cancer patients. Tivozanib met the primary endpoint of the study by delaying tumor regrowth by almost three months more than Nexavar (11.9 months vs. 9.1 months.) However, this significant improvement in progression-free survival favoring tivozanib did not help patients live longer.

Last August, shares of Aveo fell from $14 to $8 when the company first disclosed FDA's concerns about the confounding survival analysis from the tivozanib trial.

Aveo shares closed Tuesday at $7.89 but were down 11% to $7.04 in early Wednesday trading.

Aveo believes overall survival of tivozanib was snake bit by a study design that allowed patients treated initially with Nexavar to receive effective, subsequent therapy, including tivozanib. Of the 257 patients who started the study on Nexavar, 74% "crossed over" to receive treatment with other kidney cancer drugs, including tivozanib and other so-called VEGF therapies like Pfizer's (PFE - Get Report) Sutent or GlaxoSmithKline's (GSK - Get Report) Votrient.

By comparison, 36% of the patients treated initially with tivozanib went on to receive additional kidney cancer drugs, including 10% who received subsequent VEGF therapies.

In certain smaller subsets of patients, overall survival trended in favor of tivozanib over Nexavar, the opposite of what occurred in the study as a whole. Some of these alternate survival analyses were pre-defined in the study's statistical analysis plan, while others were not, a company spokesman said.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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 17,191.37 -195.84 -1.13%
S&P 500 2,002.16 -27.39 -1.35%
NASDAQ 4,637.9940 -43.5030 -0.93%

Partners Compare Online Brokers

Free Reports

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