chazzle: Thanks for quoting the protocol language
Post# of 157598
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Posted On: 10/01/2025 11:44:06 PM
Re: chazzledazzle #157508
chazzle: Thanks for quoting the protocol language on dosage that (after the initial 5 patients pass a 350 mg safety test) the 60 eventual enrolled patients will have a 50/50 chance of receiving 700 mgs of LL vs 350 mgs for approximately 1 year. Those still alive will then be eligible for Keytruda if LL has continued to to turn their cold tumors hot at that endpoint.
But as Ken has pointed out in post 157488, only 1 of 4 patients who previously received the 350 mg dose was able to elevate her PDL1 level from cold to hot; whereas 15 of 17 (88%) who received the 525 or 700 mg doseage were able to do so. And if LL's holy grail is to turn cold tumors hot,therby opening a huge new market for ICIs to save patients' lives, why must half the 60 enrollees have only a 25% chance, instead of an 88% chance, to be saved?
As I have previously posted in response to misui, I absolutely believe that Dr Jay has beseeched the FDA to allow Keytuda or another ICI to be administered once LL has turned a cold tumor hot, and I also suspect that he has requested that after the initial 5 patient safety review, that all patients receive 525 or 700 mg doses due to the 88% likelihood of PDL1 up regulation. And I continue to think that the FDA's refusal to bend in the face of this simple logic is making enrollment much more difficult than it should be. In this respect, I hope I am wrong. My track record gives me confidence in that regard.
But as Ken has pointed out in post 157488, only 1 of 4 patients who previously received the 350 mg dose was able to elevate her PDL1 level from cold to hot; whereas 15 of 17 (88%) who received the 525 or 700 mg doseage were able to do so. And if LL's holy grail is to turn cold tumors hot,therby opening a huge new market for ICIs to save patients' lives, why must half the 60 enrollees have only a 25% chance, instead of an 88% chance, to be saved?
As I have previously posted in response to misui, I absolutely believe that Dr Jay has beseeched the FDA to allow Keytuda or another ICI to be administered once LL has turned a cold tumor hot, and I also suspect that he has requested that after the initial 5 patient safety review, that all patients receive 525 or 700 mg doses due to the 88% likelihood of PDL1 up regulation. And I continue to think that the FDA's refusal to bend in the face of this simple logic is making enrollment much more difficult than it should be. In this respect, I hope I am wrong. My track record gives me confidence in that regard.
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