From memory it was something like 4 months difference in median OS.
But that was skewed by some of the control arm being given Frovenge (Frozen Provenge) once they progressed.
A subsequent study taking that into account showed the real median benefit to be over 7 months.
However, FDA approval for the label still states 4 months.
This is something that CVac may have to deal with, due to their CAN-003X study. One assumes that the FDA are confident in the trial design of CANVAS that they would allow the secondary endpoint of CAN-003 to be muddied.
Suggesting that CAN-003 may be somewhat of a formality.
What are your views?
From memory it was something like 4 months difference in median...
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