you cant be serious
i thought that is what the DSMB role specifically is - to step in and save patients
they will have a very hard time signing up patients if denying use of an ICI is the case. i certainly wouldnt be part of it. this all seems so absurd but what do i know. once again this leronlmab saga makes absolutely no sense whatsoever and defies logic completely.
please correct me if im wrong, but it seems many scenarios screw the patient possibly killing them -
1 - PD-L1 is measured and patient/doctor IS notified, but told they CANT have an ICI - which i find impossible any doctor/hospital let alone DSMB would agree to that, even though they are kind of following standard of care protocol - but is that accurate? is it true that any oncologist will know that a hot tumor environment automatically invokes ICI treatment? i have no idea.
2 - PD-L1 is measured but the patient/doctor is NOT notified, withholding life saving treatment data. which would invoke automatic lawsuit.
3 - PD-L1 is measured and the patient/doctor IS notified, patient /doctor decide to leave trial in order to take ICI and LIVE, hurting trial data. which of course is insane.
the FDA is in a pickle here, maybe setting themselves up for a set of lawsuits if these patients die.
i thought DSMB is there to step in and save the patients if a trial turns a certain corner. i would think that PD-L1 levels rising to ICI effectiveness level would be exactly that and they would immediately do what ever it takes to save a patient. but what do i know.
why is this so difficult for THEM to understand if its easy for ME to understand?
OH RIGHT...FDA
clearly they are in the business of approving / denying drugs, not saving lives.
absolutely they should have been given trodelvy, as it became SOC if it was approved - i would have bailed on the trial in a second, hope you would too...trials should be malleable to change direction if a new drug is approved, at least give the patient the option to take trodelvy +leronlimab and create a new arm - or die? ...crazy
Quote:but I don't think we sacrifice the trial to save a few patients, unfortunately,
i thought that is what the DSMB role specifically is - to step in and save patients
they will have a very hard time signing up patients if denying use of an ICI is the case. i certainly wouldnt be part of it. this all seems so absurd but what do i know. once again this leronlmab saga makes absolutely no sense whatsoever and defies logic completely.
please correct me if im wrong, but it seems many scenarios screw the patient possibly killing them -
1 - PD-L1 is measured and patient/doctor IS notified, but told they CANT have an ICI - which i find impossible any doctor/hospital let alone DSMB would agree to that, even though they are kind of following standard of care protocol - but is that accurate? is it true that any oncologist will know that a hot tumor environment automatically invokes ICI treatment? i have no idea.
2 - PD-L1 is measured but the patient/doctor is NOT notified, withholding life saving treatment data. which would invoke automatic lawsuit.
3 - PD-L1 is measured and the patient/doctor IS notified, patient /doctor decide to leave trial in order to take ICI and LIVE, hurting trial data. which of course is insane.
the FDA is in a pickle here, maybe setting themselves up for a set of lawsuits if these patients die.
i thought DSMB is there to step in and save the patients if a trial turns a certain corner. i would think that PD-L1 levels rising to ICI effectiveness level would be exactly that and they would immediately do what ever it takes to save a patient. but what do i know.
why is this so difficult for THEM to understand if its easy for ME to understand?
OH RIGHT...FDA
clearly they are in the business of approving / denying drugs, not saving lives.
Quote:Think about it like this...when we were doing our mTNBC trial in 2020, Trodelvy received approval before our trial was over. Should they have put everyone in our trial on Trodelvy because it received approval and we hadn't proven we worked yet?
absolutely they should have been given trodelvy, as it became SOC if it was approved - i would have bailed on the trial in a second, hope you would too...trials should be malleable to change direction if a new drug is approved, at least give the patient the option to take trodelvy +leronlimab and create a new arm - or die? ...crazy
Quote:Misiu, I've respected you ever since we used to talk on iHub and I agree that the best thing for patients would be if they could get an ICI as soon as their PD-L1 goes up but a couple of things...
First off, it's not up to us, it's up to the FDA.
Second, it doesn't appear that you just make a phone call and change your trial protocol.
Third, I don't think it would be good to take patients out of our trial to put them on ICI if their PD-L1 goes up if that means it messes up our trial. While they would absolutely benefit, how many people will not benefit and die if LL doesn't complete its trial and gets delayed from being approved further into the future?
Think about it like this...when we were doing our mTNBC trial in 2020, Trodelvy received approval before our trial was over. Should they have put everyone in our trial on Trodelvy because it received approval and we hadn't proven we worked yet?
I hope they approve the change in a way that it doesn't mess our trial because it will help patients and I think it will make LL look better but I don't think we sacrifice the trial to save a few patients, unfortunately, if it means further delay from getting LL to the public. At the very least, I do think the DSMC should recommended 700 mg for everyone after the second review but that will be up to our results at the time. Let's hope that 60% ORR holds and LL saves some lives on its own.
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