Th D9902A study is in statistical quagmire because it was stopped in 2002 with only 98 patients enrolled. That a survival benefit can be discerned at all in such a small group is surprising and potentially profound. Unfortunately, due to study design, survival is the secondary endpoint, so its validity is in question---appropriately.
snip The D9902A study was a double-blind, placebo-controlled Phase 3 study of Provenge in patients with asymptomatic, metastatic, androgen-independent prostate cancer. D9902A was originally designed to be the companion study to Dendreon's completed first Phase 3 study, D9901. The D9902A study was stopped in 2002 after 98 patients were enrolled when the analysis of D9901 showed that no significant benefit in time to disease progression had been observed in the overall group, but that a benefit was seen in the subgroup of patients with Gleason scores of seven and less. The Company amended the D9902A protocol to become what is the ongoing D9902B pivotal Phase 3 study.
I don't know what I am going to do with this news. I can see a case to sell out of indignation that the company repeatedly publicizes data of questionable repute. I can also make a case to buy on the inevitable dip today. Such a decision would be based on blind faith that the company is not lying and will come thru in the end with the promised positive final data from D9901, in which 3 year survival data will be a prespecified endpoint.
Scientific and mathematical opinions would be appreciated.
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