Provost's Feb presentation at FDA, showed significant difference between KM curves of pooled (9901+9902a) overall survival for provenge treated patients with above- vs below- median CD54 upgregulation, compared to placebo. Does anyone have a p-value?
However there is a remote likelihood of the difference seen in survival could be an artifact of CD54 discretization. The Friday presentation showed that separation is genuine, by way of a cox regressiOn (I suspect) which treats the CD54 upregulation as a continuous variable and yielded a p-value of 0.011.
I wonder if they tried to go far the prentice's rules for proving that CD54 upregulation being the surrogate of OS.
Data has shown 3 of 4 prentice's criteria for surrogacy:
1. Provenge improves survival;
2. Provenge affects CD54 upregulation: Patients who receive provenge has upregulation, those who did not receive provenge have no CD54 upregulation
3. CD54 upregulation improves survival.
Did anyone see data that would validate the the 4th condition, Provenge's treatment effect can be fully captured by CD54 upregulation? I bet if they do one, they could show it.