For one, the sub-sentence that you missed to copy gives a hint that paxalisib is doing something:
The median OS for patients with unmethylated GBM treated with RT/TMZ pooled from 5 phase III studies (N = 655) was 14.11 months (95% confidence interval [CI], 13.18–15.04) with a median PFS of 4.99 months (95% CI, 4.25-5.72)
This compares to 8.4 months (https://www.kaziatherapeutics.com/site/PDF/369a5538-ea60-4e0b-ad6d-1b5cd2c37596/KaziaCorporateDeck, slide 19)
You may argue that PFS means very little when it does not translate into increased OS vs. standard of care.
Kazia does not think so.
Using data from the pivotal study of TMZ as historical control to estimate the benefit of paxalisib in the absence of a comparator in the study isn’t necessarily wrong. The studies included in the meta-analyses may show differences in terms of study populations in terms of their level of fitness, etc. They are never fully identical.
There appears to be an increased survival with TMZ in unmethylated, newly diagnosed GBM patients since its approval - which isn’t unusual as HCP gain experience using it.
The results from paxalisib Phase II may be solely due to the improved TMZ performance - the difference in PFS suggests against it.
As spyglass just said - Phase III will tell.
And yes, GBM has proven to be a graveyard for my compounds.
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