Well, if a patient is diagnosed as recurred in 8 months but lives beyond their expected OS, that is likely pseudoprogression. But you can’t UNDO the previous finding. They can actually see that the treatment extended OS and subsequently, what looked like recurrence goes away.
The problem is you really can’t undo the previous incorrect determination.
The reality is that PFS is not a measure the FDA considers a direct benefit for patients. It is why they re-reviewed all the immunotherapy drugs this last year. PFS is a proxy, meaning they HOPE that it means patients will live longer and with a better quality of life. That is frequently not the case with the “best” drugs, but they decided the quality of life was better even if the patients did not live longer.
In this case you have a drug that 1) shows that it is literally working with pseudoprogression, validating the mechanism; 2) patients live longer, without question for both newly diagnosed and recurrent GBM. No one else has shown these outcomes. And it is obvious given the nature of the immune response and pathologies of such diseases that they can likely tweak combinations such that patients will probably get substantially more benefit from having an expanded toolbox of combinations, including DCVax-L.
It’s unfortunate that Adam can befuddle people’s understanding of what is being shown here, and that doctors need to explain things in a roundabout manner because “science”, they need to prove even the most obvious and basic things. But this is quite a clear cut victory and a major one. Adam can’t undo it no matter how disruptive he gets, no matter who he tries to intimidate or how many tweets or columns he writes. He is powerless to undo the truth.
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