House--excellent summary of the rationale for the mCRC trial. And the stakes involved.
"PD-L1 is all the hype in our camp right now but the 700mg group could blow the SOC out of the water on the ORR. Best case scenario, we confirm PD-L1 increase and show substantially better ORR than the SOC."
That is my expectation. I was going to say "hope"... but the Creatv Microtek numbers are so positive and consistent about leronlimab's effect on the cancer micro-environment that I think they are trying to tell us something... And that is--something good is going on here!
If the modifications to the trial are accepted, and those who progress get an ICI if their PD-L1 numbers say so, we can add to your best-case scenario. That would be--clinical proof that the combo works in a second cancer indication. And saving lives that would otherwise be lost when following the original trial protocol. And a boatload of data on leronlimab as a stand-alone treatment. Not bad for a single Phase II trial... like, possibly the most consequential trial of this young century.
I worry about the 350mg cohort, of course. It seems like their lives are in the hands of the DSMB, and whether or not they will get bumped up to meaningful dose that will increase their PD-L1 numbers. The lack of transparency about this process and the power they wield bothers me to no end. If anyone has any insight into how the DSMB works, or has served on one, please enlighten us.
I have no idea if the FDA is going to
"PD-L1 is all the hype in our camp right now but the 700mg group could blow the SOC out of the water on the ORR. Best case scenario, we confirm PD-L1 increase and show substantially better ORR than the SOC."
That is my expectation. I was going to say "hope"... but the Creatv Microtek numbers are so positive and consistent about leronlimab's effect on the cancer micro-environment that I think they are trying to tell us something... And that is--something good is going on here!
If the modifications to the trial are accepted, and those who progress get an ICI if their PD-L1 numbers say so, we can add to your best-case scenario. That would be--clinical proof that the combo works in a second cancer indication. And saving lives that would otherwise be lost when following the original trial protocol. And a boatload of data on leronlimab as a stand-alone treatment. Not bad for a single Phase II trial... like, possibly the most consequential trial of this young century.
I worry about the 350mg cohort, of course. It seems like their lives are in the hands of the DSMB, and whether or not they will get bumped up to meaningful dose that will increase their PD-L1 numbers. The lack of transparency about this process and the power they wield bothers me to no end. If anyone has any insight into how the DSMB works, or has served on one, please enlighten us.
I have no idea if the FDA is going to
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