impact of time in cvac immunotherapy, page-9

Hi Birdseye – really great post and thanks for sharing this information.

I was interested in your observation from the presentation that CVAC in the CAN3 trial is behaving in a similar fashion to Provenge (prostate cancer). As I understand it Provenge is significant for overall survival (OS) but not PFS.

If this is the case the first problem this raises is that the primary end-point for the CAN3 trial is PFS not OS (which is a secondary outcome). Which means the trial is in danger from missing one of its two primary end-points.

It also suggesting to me that the researchers are saying that because they are seeing some evidence of an immune response then this means there must be an effect and if its not on PFS then it must be on OS.

Well hopefully this turns out to be the case. But it wasn’t Plan A. And while a strong PFS will nearly always indicate a significant improvement in OS non-significant PFS data only sometimes are associated with significant OS (and most often not).

Happy to be corrected on any misunderstandings I may have around this.

All the best Southoz.