Biotech Values

[DewDiligence]

Re: Tarceva in pancreatic cancer

It looks like OSIP and DNA told investors a half-truth when they said the phase-3 trial hit its endpoint for overall survival.

According to the briefing docs posted today, the OS endpoint was met only after Cox analysis was used to correct for a performance-status imbalance between the trial arms. This is not such a bad thing per se, but it’s not what the companies told investors.

The clinical (as opposed to statistical) significance of adding Tarceva to Gemcitabine in this setting is tiny—an increase in overall survival of less than two weeks—but we already knew that. (Gemcitabine itself showed marginal efficacy when it was approved as monotherapy treatment in this indication.)

The briefing docs are at:

http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4174B1_04_01-FDA-Clinical-Tarceva.pdf

Dew