Slide #13 of the presentation is interesting following on from the PFS model I posted a few months back.
The trial was designed with a primary endpoint of >6 week PFS improvement. Their graph refers to 6-12 weeks as "range of potential outcomes". I take that to mean that <6 weeks is not a potential outcome.
They also say that "... target improvement of 8-12 wks would be a significant (46-70%) improvement in efficacy". Now that's a fairly open statement and not a promise that 8-12 weeks will happen. But the range is well above the original 6 weeks.
Also, they refer to 2 studies for comparison - van Cutsem (VELOUR) and Tournigand (OPTIMOX1). I'm not sure about the Tournigand one. The paper I read just had FOLFOX figures. But the Van Cutsem one has a FOLFIRI PFS similar to the Peeters PFS data that I used as a baseline comparitor in my model, reinforcing that the current trial is well into +ive territory.
I still think that the PhIII PFS results will be at the upper end of the range.... or higher. That would be nice to see a biotech under-estimate efficacy for a change. Waiting with keen interest!
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