The GBM patients eligible for Agenus' Prophage study all had prior surgical resection of their tumors that was no less than 90% complete. By comparison, only 39% of patients enrolled in the Stupp study had complete tumor resection.
A later analysis of the Stupp study was published just looking at patients with complete tumor resection. The median overall survival for these patients was almost 19 months, very similar to the Prophage results, especially after factoring in the relative size of these studies. Agenus enrolled 46 patients in its phase II study while the Stupp study enrolled 573 patients, including 226 patients with complete tumor resection.
In a larger, controlled phase III study, that 23.3-month median overall survival for Prophage will undoubtedly fall.
In his Seeking Alpha story, Smith takes dubious cross-trial comparisons to another level by looking at two studies of Avastin in newly diagnosed GBM patients conducted by Roche (RHHBY). The control arm in both studies was the current standard of care -- radiation and temozolomide -- with median overall survival of 16 months and 17 months, respectively.Once again, Prophage looks better, but it's an illusion. As with Stupp, the GBM patients enrolled by Roche in its studies were generally sicker than those enrolled by Agenus. Fifty-nine percent and 42% of patients treated with standard of care entered the study with complete tumor resections. Agenus intends to meet with the FDA so that it can move ahead with a phase III study of Prophage in newly diagnosed GBM patients. As I've shown, the clinical evidence supporting this effort is dubious, at best. But this is biotech, where it's often more important to have a drug in phase III trials than it is for that drug to have any chance of success. That's particularly true for a company like Agenus, where raising cash is mission number one. Investor concerns that cholesterol-lowering PCSK9 drugs, including one under development by Amgen (AMGN), will eat into the market share and revenue generated by Aegerion Pharmaceuticals' (AEGR) Juxtapid have resurfaced over the past week or so. The result: volatility in Aegerion's stock price. Shares hit $97 on Sept. 10 but fell to $84 on Sept. 18. The stock was rebounding Thursday as some analysts came to Aegerion's defense.
@adamfeuerstein Adam where do you stand on this? Why are folks worried abt a "threat" that is 2.5 yrs away? In the meantime, $AEGR kicks ass— Leo (@BiotechLeo) September 18, 2013
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV