kyoto27

Cougar Biotechnology: Stalking Prostate Cancer

Bryan, you say:

“Both treatments Dendreon's and Cougar's fall short, time to progression for Provenge and no survival statistics for abiraterone.”

Did Provenge really miss ‘time to progression?’

The p value for the primary endpoint of cancer progression was p=0.052, barely missing the p=0.050 threshold. For Howard Scher and Maha Hussain, this narrow miss was blown up to be an utter failure. They said that because the p value did not reach 0.050, then all additional data (including survival) should be discarded. Basically, their position was that because the odds of being successful in progression were only 94.8% and not 95.0%, there was no correlation between the two metrics and the 99.0% survival odds should be thrown in the trash.

And remember, the overall survival p value in 9901 was 0.01, easily beating the p=0.05 threshold. This goes to the crux of the anger of the Provenge advocates. Statistical significance on survival is the "gold standard" by which the FDA judges all oncology treatments, and Provenge met it with flying colors in the 9901 trial.

Cougar Biotechnology: Stalking Prostate Cancer

You say:

"There is a huge unmet need for an efficacious therapy with minimal side effects that has significant survival benefits. With the dismal performance of Abbott's Xinlay and Spectrum Pharmaceuticals' Sartraplatin, Cougar Biotechnology may take the lion's share."

With all due respect, the odds right now look appear to tilt more in favor of Dendreon's Provenge taking the 'lion's share' following Provenge's IMPACT trial interim results (this year) or final 2H09. With virtually no side effects, and very significant survival benefits --not to mention a positive FDA AC panel recommendation already in it's pocket, there is very little not to like about Provenge's odds to run the table. And remember, Provenge approval also validates Dendreon's 'platform technology' which opens the door to a paradigm shift in how cancer will be treated in the 21st century.

We live in exciting times....




Disclosure: none