(Total Views: 551)
Posted On: 09/11/2025 12:41:59 AM
Post# of 156892
mfglola: Unfortunately I still don't think that ICI dosing during the 48 week trial will be allowed. If I remember correctly Dr. J addressed this saying it was too bad that the FDA was insisting on a trial that purely focused on the disease reaction to LL and did not want it complicated by the concurrent use of an ICI.
Here are two snippets from the CFO's speech transcript that Enjay provided the link for:
"So the open label part is important because it will allow us to view, PD-L1 data as we go along
00:07:48:18 - 00:08:19:11
and hopefully we'll see our mechanism of action, that positive PD-L1 positive, throughout the study."
To me this reinforces that the focus of the trial is in monitoring patient disease responses to LL and PD-L1 levels "throughout the study". And the following snippet and the use of the word "beyond" implies to me that ICI's are allowed only after the 48 week trial for patients whose disease has progressed even with LL dosing.
"So the other important part is the rollover protocol, which we plan on putting in place. That will allow, ensure that CRC patients can continue Leronlimab treatment beyond the 48 weeks, and allow patients with disease progression the opportunity to receive Leronlimab in combination with an ICI. So that's really important."
00:09:17:28 - 00:09:34:23
"That kind of tests our theory as well, that making these patients PD-L1 positive will be effective for ICI treatment."
Here are two snippets from the CFO's speech transcript that Enjay provided the link for:
"So the open label part is important because it will allow us to view, PD-L1 data as we go along
00:07:48:18 - 00:08:19:11
and hopefully we'll see our mechanism of action, that positive PD-L1 positive, throughout the study."
To me this reinforces that the focus of the trial is in monitoring patient disease responses to LL and PD-L1 levels "throughout the study". And the following snippet and the use of the word "beyond" implies to me that ICI's are allowed only after the 48 week trial for patients whose disease has progressed even with LL dosing.
"So the other important part is the rollover protocol, which we plan on putting in place. That will allow, ensure that CRC patients can continue Leronlimab treatment beyond the 48 weeks, and allow patients with disease progression the opportunity to receive Leronlimab in combination with an ICI. So that's really important."
00:09:17:28 - 00:09:34:23
"That kind of tests our theory as well, that making these patients PD-L1 positive will be effective for ICI treatment."
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