"but I thought they were amending the protocol so that if a patient did have disease progression with increased PD-L1 they would be eligible for an ICI"
I think thats how they stated that they anticipated amending the protocol
But its hard to decipher exactly what it means
I dont think CYDY at the time could say anything other than "if disease progressive after this or that, we will do this" . They couldnt really be specific
I doubt anyone really knows the best path forward
But I would bet that Dr J would like to begin ICI if patients stops improving, if tumor stops shrinking/responding etc
There is no reason I can think of that the FDA would not consider Leronlimab as the reason pdl1 upreg'ed to become ICI treatable and just ignore all the previous history of it not happening before.
But Im just killing time and trying to figure it out while we wait
Surely we will hear the decision or figure it out from watching the trial site soon
One reason Im not super worried is we were discussing the upcoming TNBC trial at the same meeting
So all this ICI pdl1 talk is going to be front and center in everything going forward and in every single FDA meeting
So the FDA better get ready to wrap their brains around it
I think thats how they stated that they anticipated amending the protocol
But its hard to decipher exactly what it means
I dont think CYDY at the time could say anything other than "if disease progressive after this or that, we will do this" . They couldnt really be specific
I doubt anyone really knows the best path forward
But I would bet that Dr J would like to begin ICI if patients stops improving, if tumor stops shrinking/responding etc
There is no reason I can think of that the FDA would not consider Leronlimab as the reason pdl1 upreg'ed to become ICI treatable and just ignore all the previous history of it not happening before.
But Im just killing time and trying to figure it out while we wait
Surely we will hear the decision or figure it out from watching the trial site soon
One reason Im not super worried is we were discussing the upcoming TNBC trial at the same meeting
So all this ICI pdl1 talk is going to be front and center in everything going forward and in every single FDA meeting
So the FDA better get ready to wrap their brains around it
5
