War - bavi is either beating the overall OS of the opdivo vs doce NSCL trial by a couple of weeks (or more) or the big enrollment ramp up did not start til six months into the trial. In which case, we might see a first look-in by October. Third possibility is that a first look-in was triggered, but has not been looked into yet by the DMC. Fourth possibility is that peregrine has the first look in info and plans a review before releasing any news. I posted the below two weeks ago. I believe there could be news at anytime now.
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I have done an enrollment/ event computer simulations of this and assuming the company will disclose first look in as soon as possible, even with only 7 patients enrolled in the first three months and the first two being in he healthier group and 28-29 per month till October this year and tapering in November , when I apply Doce vs Opdivo OS with both ECOG 0 and ECOG 1 (4groups total) to the simulation, we would have already triggered a first look-in. My model also assumes N=589, 33% events =194
I used
ECOG 0 bavi 15.0 for 25%
ECOG 0 doce 10.7 for 25%
ECOG 1 bavi 9.7 for 25%
ECOG 1 Doce 8.0 for 25%
Is there any way to know the number of sites opened each month and the enrollment rate per month per site? I could then create a better simulation.
My best guesstimate right now is first-look in PR between now and end of September.
Anyone else have simulations?
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