Replies to post #154466 on Biotech Values

[hirogen]

I wish these vaccine companies that run phase 3 trials would share some basic info regarding patient response to the antigen.

Immune response data from Provenge's IMPACT trial is probably the most substantive. But what confounds me is that for the most part the data shows broad spectrum immune response, but not so much in the way of specificity against PAP (and I'm not including the fusion protein). Ironically I think the Neuvenge trial (HER2 target) in bladder cancer could give some insight to Provenge's MOA. Either it shows no efficacy or it's efficacious with severe autoimmune reactions. If it shows efficacy and a mild AE profile then I'll really be confused.

With the Stimuvax trial failure I'm rethinking my criteria to evaluate cancer vaccines and that they warrant a little more cynicism than usual. Your efficacy/AE principle is a good one to follow. Provenge approval created an efficacy/AE paradigm that this is how cancer vaccines should be. I'm beginning to think that it being an exception is going to be the general rule.