Of course this is a false description, but that never stops you. PFS is only for early approval. It is a surrogate measure for survival. But with immunotherapies, especially brain tumors, early on the methods for determining recurrence did not take into account the actual response to an immunotherapy, which, duh, causes inflammation, which looks like a flair on a scan, but is actually the drug working. They can’t take back those designations, but when everyone is living longer, a lot longer in certain instances, that is a survival benefit and that would make PFS in this instance, the old way of measuring it, not a valid surrogate for survival and therefore not a valid measure of failure or success in any way.
Subsequently, PFS has been adjusted, PFS+6, for instance, but this trial was already started and far along.You can’t adopt a newer PFS plus that may be flawed as well. Hence, better measures have evolved and NO, they couldn’t just throw in some ORR, at that point. That’s ridiculous and stupid and shows you have no idea of what you post.
They got permission to make OS primary, and to use a very thoroughly vetted, externally proposed, expertized, blinded placebo based on concurrent trials that has the same placebo standard of care.
You can invent all you want. You can look to doctors with competitive treatments to make the argument based often on ignoring key parts of the trial, and details.
But the reality is, virtually all the other drugs that have been approved have in fact actually failed, at one point or another and still been approved based on other data. This trial does not have those problems.
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