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Might that be the reason the FDA won't allow us to

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Post# of 157598
(Total Views: 462)
Posted On: 09/29/2025 6:12:05 PM
Posted By: ohm20
Re: HouseofCards #157366
Quote:
Might that be the reason the FDA won't allow us to add an ICI until we have shown that we can increase PD-L1 in mss CRC? It doesn't seem like the FDA will let you say "Look what we did with an ICI in breast cancer in a post hoc analysis, you should let us add an ICI to our mss CRC trial."




Quite possibly. That the CRC patients were in a basket trial, measurement of PD-L1 might not have taken place. There is no mention of that in the ESMO poster. That the MOA of increased PD-L1 expression by leronlimab is a response to the rise in CD8+ T-cells it's common sense that it would exhibit the same across all cancers with a high CCR5 expression. But the FDA needs more than common sense.

Observed Survival Following Treatment With Leronlimab In Patients With
Metastatic Colorectal Cancer


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