Replies to post #148066 on Biotech Values

[Summer2762]

The xtandi docs are now available at FDA's website.

The info I was looking for (time to subsequent therapy) is not there. Thus, I could not completely prove my suspicion that the approval of cabazitaxel & abiraterone acetate during the enzalutamide trial played a role in the OS advantage that Xtandi was able to show.

My theory is simple. If enzalutamide extended the OS even a little bit, more patients in the enzalutamide arm were able to use cabazitaxel & abiraterone acetate (simply because these treatments become available later). This contributed to the HR of enzalutamide.

My intent is not to question whether enzalutamide is active, or better than abi or cabo, etc. It is to quantify the effect of later availability of cabo & abi to the HR and then extend that info to the SYNERGY trial as, similar to the AFFIRM trial, abi & enzalutamide got approved during the SYNERGY trial. If OGX-011 has even a minor OS advantage, would these approvals extend the HR of the SYNERGY trial in favor of OGX-011?

I think yes. However, I cannot prove that.