Timing16 Dec 2023 13:11
There has been a lot of discussion recently as to why Avacta chose to present the P1a results so far, instead of waiting until the end of the 3-weekly dosing (i.e., the end of C7). Some ideas include: external influence by a potential partnering company (i.e., they wanted the data out), timing to hit a major conference, etc.
However, in light of what we learned yesterday, that the patient selection criteria for the bi-weekly *and* C7 has been changed to focus on patients with little or no previous cytotoxic treatment, there may be a more straightforward reason.
By changing the selection criteria they expect to maximise the chance that a patient responds to ava6k. But in so doing, they are limiting their potential patient pool massively. There are only a handful of patients that would be expected to be available for a P1a trial (i.e., terminal) with little or no previous treatment. If you think back to Science Day, Prof. Twelves even said the fact that the trial had not included many patients which might be expected to show a response was his fault, and that the reason was that if they would have made that restriction, only a few patients would have been dosed up to that point, instead of the ~20 that they had.
So Avacta knew that with the new selection criteria, they would have a more restricted patient population, so C7 would likely take longer than the other cohorts. Hence, C7 may not end until mid to late Q1 (or perhaps even Q2), which is not something that they wanted to wait for. In this case, it makes perfect sense to present the C1-C6 results when ready and "as much of C7 as possible up to the cutoff date."
While C7 will likely take much longer than C5 or C6, the focus on (near) first line patients could lead to some spectacular results for the patients.
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