Thursday, March 09, 2023 12:23:27 PM
What seems to have been lost for some reason is that they have two shots on goal with AML. Active and adjuvant. The active setting never had as much promise as the adjuvant setting. It's been said countless times that this was a heavily pretreated patient population who have basically run out of options. Not responding to the stem cell transplant is basically a death sentence and that's where these active patients are at. To date all data from the PII has been in the active setting. It's not really surprising that it hasn't been stellar data. The MRD data alone is worth keeping an eye on. If they can effectively turn patients MRD- it will be a big deal. People's expectations have just been too high here and I expect that is because they are confusing the fact that this recent data is from the active setting. What we really need is adjuvant data but that takes longer to collect as patients need to have been treated for at least a year before meaningful data can be collected. This is where the AML data can show something.
I wouldn't say new. This has arguably always been their best shot and has shown the most robust data to date. The issue is around the time of the merger CAR-T therapies were being granted approval in this indication. It's a little more difficult to recruit for a cancer trial where there are multiple approved therapies already. No doctor is going to recommend their patient enroll in a trial when there is an approved therapy to prescribe. This is the main reason they chose to go with AML as their first trial. Now that they were able to formulate a path forward this remains their best bet and should probably be their top priority.
Definitely a wild card. The one CR they saw in the PI happened far enough into the treatment timeline that it would not have been due to the chemo the patient was given so there could be a little promise they can make this work even though they only added one new antigen target. The bar is also going to be very low here due tot he lack of treatment options for pancreatic cancer. Once they get this trial up and running it should be fairly quick to results. I've said it in the past and I'll maintain my view that this is where I expect to see a partnership come in to play should data support further trials.
My DD is not a substitute for your DD
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