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 Screwed Up but Its Kidney Cancer Drug Is Real

CAMBRIDGE, Mass. ( TheStreet) -- AVEO Oncology (AVEO - Get Report) has had a difficult time since its lead cancer compound tivozanib was roundly panned at a May 2 FDA advisory panel. By a 13-1 vote, experts on the FDA's panel concluded tivozanib did not demonstrate a favorable risk/benefit for the treatment of advanced kidney cancer. Despite scathing critiques of the design and conduct of Aveo's phase III trial, a deeper look at the data demonstrates tivozanib's efficacy is actually fairly similar to previously approved kidney cancer drugs. While the phase III trial might not be completely predictive of future success, at the very least, the trial is strong enough to justify an AVEO valuation above cash on hand.

There has been a lot written about the mistakes made by Aveo in designing and conducting the tivozanib study, and how these errors could have -- and should have -- been avoided. Setting aside that debate, I want to look at the tivozanib data in isolation to see what they say about the actual clinical activity of the kidney cancer drug. In particular, the FDA advisory panel compared tivozanib to seven other drugs approved in kidney cancer: Onyx Pharma's (ONXX) Nexavar, Pfizer's (PFE - Get Report) Sutent, Inlyta and Torisel, Novartis' (NVS - Get Report) Affinitor, Roche's (RHHBY) Avastin and GlaxoSmithKline's (GSK - Get Report) Votrient. Are the tivozanib data dramatically out of sync with the trials results of the approved drugs?

Chemist and pharmaceutical analyst John Tucker (@JohnTuckerPhD on twitter) conducted an analysis correlating progression free survival (PFS) with overall survival (OS) for all seven drugs to determine the tivozanib results from Aveo's phase III trial were anomalous. If the tivozanib trial produced flaw results in terms of either PFS or OS, then it should appear outside of the correlation seen with the approved drugs.

I've reproduced Tucker's analysis below:

One of the first things to note is the relatively strong correlation between PFS and OS among the seven approved drugs. The blue diamonds represents the approved drugs with the regression line superimposed. The only real outlier is Torisel (the blue diamond sitting by itself below the regression line) with a median PFS of 5.5 months but a median OS of only 10.9 months. Based on the regression line, Torisel's median OS should have been closer to 15 months.

Now, look at how closely tivozanib (the red square) hews to the regression line. The median OS is slightly longer than one would expect given the median PFS but certainly within the margin of error. It's difficult to argue from these data alone that tivozanib is not an active kidney cancer drug -- perhaps the most effective drug compared to its peers, in fact.
1 of 2

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 0.85%
GSK $40.51 -1.10%
NVS $85.24 -0.70%
PFE $32.77 -0.06%


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