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Posted On: 08/22/2025 7:53:06 PM
Post# of 158121
I have a question about the meaning of that same quote from the JL interview:
Quote: [00:30:10]:" ...........what we're going to be doing shortly is submitting a request to the FDA for a meeting at which point we're going to give them a rollover protocol for the Colorectal cancer patients that we're monitoring their PD-L1 status during the study and in the rollover protocol. We hope to then provide them a checkpoint inhibitor to see if we can replicate that clinical benefit, that survival benefit that we saw in the breast cancer patients."
In previous communications I got the impression that the "rollover protocol and follow-up treatment with a checkpoint inhibitor" would only happen after trial participants had concluded the full one year trial. Is that still the correct assumption, or does this language change the trial so that patients who respond with increased PD-L1 expression by the tumor would be immediately eligible for treatment with an ICI? (I hope, I hope!!!) Ganesha
Quote: [00:30:10]:" ...........what we're going to be doing shortly is submitting a request to the FDA for a meeting at which point we're going to give them a rollover protocol for the Colorectal cancer patients that we're monitoring their PD-L1 status during the study and in the rollover protocol. We hope to then provide them a checkpoint inhibitor to see if we can replicate that clinical benefit, that survival benefit that we saw in the breast cancer patients."
In previous communications I got the impression that the "rollover protocol and follow-up treatment with a checkpoint inhibitor" would only happen after trial participants had concluded the full one year trial. Is that still the correct assumption, or does this language change the trial so that patients who respond with increased PD-L1 expression by the tumor would be immediately eligible for treatment with an ICI? (I hope, I hope!!!) Ganesha
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