Post by
Quentin30 on Mar 08, 2023 5:10pm
Not statistically significant
It's worth remembering that the Bracelet-1 trial is not powered to provide data that can give statistical clarity. The primacry end point of this trial is
ORR is measured at 16 weeks, and Safety and Tolerability until the end of the treatment...
We know from IND-213 that the survival curves only start to separate after approx 10 months (when immune response occurs). The last patient for whom ORR was measured was Aug 1, 2022.
So if this last patient follows the same trajectory, they should also start to separate from the Non-Pela group in another 2 months (unless they were from Cohort 1 on Pax alone).
First patient was enrolled on June 10, 2020, so ALL primary measures and secondary measures would have been collected for that patient by now. We can use these dates to guestimate when there may be sufficient body of data to show if combo with Pela is doing better than with Pax alone.
My problem with a Phase III design, is if Pela + Pax duplicates the results of IND-213, what additional OS do we need to see from the triplet (With CPI) to make this a worthwhile investment from the likes of Pfizer. Remember the 'primary measure' ORR data must now be COMPLETE for all three cohorts. IF there was a clear distinction between Cohorts 2 and 3, then Pfizer would have pulled the trigger by now.
To see any OS advantage, this will take until mid 2024 (when the study finishes). So the question is, WHY would Pfizer invest in a Phase III until such time as they had data to show that the triplet is significantly better. I don't think we're going to be seeing a Phase III in mBC this year folks, cause ONCY cannot go it alone. Our saviour will be PANC, and that is NOT going into Phase III either, that as stated in the recent call, will be a Phase II/III.
And who is gonna pay for that?? interesting times.
Comment by
m00nsh0ts on Mar 08, 2023 6:47pm
Pfizer was never going to pull the trigger at the end of the 90 days, knowing that they'd start a multi billion bidding war without more de-risk, that will be the "truly impressive" data to be revealed at ASCO in June.
Comment by
Lesalpes29 on Mar 08, 2023 7:34pm
As I said in my previous post. We think the same. Pfizer will be one fighter. GL
Comment by
Buckhenry on Mar 08, 2023 8:46pm
if they layoff robots and AI in the future.... are they entitled to unemployment benefits?........ you think im kidding about this question.... just wait.