(Total Views: 461)
Posted On: 11/21/2025 2:17:56 PM
Post# of 158772
Quote:
ICI should be added as soon as patients will develop high PD-L1 in our present CRC trial..
Yes, I think this is what Dr. L is trying to do and hopefully he is successful. I don't know if FDA will agree.
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The Rollover trial they talking about is another trial for patients who developed elevated Pd-L1 after we finish this 12 months CRC,
I think there is a misunderstanding here. We do not complete this trial first, crunch the data, report results and then start the rollover trial. The rollover trial is an extension trial to our current main trial. As soon as a patient's disease progresses and they show elevated PD-L1 (even if it is after only 3 months), they have "completed" the main trial and are eligible to be rolled over to the the extension study. There is no waiting for the patient. It would be unethical. To my knowledge, neither Dr L nor Hoffman said patients would have to wait 12 months.
Recall that the rollover study will also allow patients who have responded to leronlimab without ICI to continue to receive treatment after 12 months.
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