InvestorsHub Logo
icon url

iwfal

02/18/11 12:29 PM

#115099 RE: biomaven0 #115096

just look at the plot of tumor shrinkage for people who have already had docetaxel.



Well, I don't yet speak tumor shrinkage (i.e. unfamiliar with historical data for this metric) and the other traditional data is still way too immature to be telling:

a) PFS - median is mildly better than Docetaxel for PC, but very very few patients out there so it doesn't mean much.

b) Response rate - Not familiar with PCa Response rates per se, but 6% Confirmed Response is not particularly good based upon other cancers and, for instance, typical limits required by the FDA in single armed trials.

The strongest data for me (indicating some kind of activity) is the discontinuation part of the trial - the giant cliff in placebo vs no progression in the treated. (Note that I believe it is statistically strong despite the huge block of censored in treated because that block of censored occurs a few days AFTER the cliff in treated. Probably an artifact of progression measurement being only every 4 weeks or so.) That said, I believe cancer typically has a bounce-back effect - remove treatment and the remaining cancer is hyper-aggressive. Thus the problem of PFS not correlating particularly well with OS. And discontinuation trial exaggerating the efficacy.