Ohm, am I remembering correctly that the company h
Post# of 157598
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Posted On: 09/29/2025 5:34:46 PM
Ohm, am I remembering correctly that the company has not reported on PD-L1 in the CRC patients from the basket trial? 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."
If this were a mTNBC trial that was just getting started and we had received the data from Amarex then I think they might let us add one, or conversely, if we had measured PD-L1 in the mss CRC patients and had data that showed it increased then they might let us add it to the current trial but I don't think you can take provocative data about one cancer and then apply it to another cancer. I wish we could but on the other hand, Keytruda has some pretty serious side effects so without proving that we up regulate PD-L1 in mss CRC (not mTNBC), the FDA can't allow patients to be subjected to those side effects with no confirmation that there may be benefit.
If this were a mTNBC trial that was just getting started and we had received the data from Amarex then I think they might let us add one, or conversely, if we had measured PD-L1 in the mss CRC patients and had data that showed it increased then they might let us add it to the current trial but I don't think you can take provocative data about one cancer and then apply it to another cancer. I wish we could but on the other hand, Keytruda has some pretty serious side effects so without proving that we up regulate PD-L1 in mss CRC (not mTNBC), the FDA can't allow patients to be subjected to those side effects with no confirmation that there may be benefit.
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