Ann: GBM Agile Update, page-176

My comments follow:

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The statement you are referring to is made in reference to recurrent GBM. The 15+ months demonstrated by paxalisib in the GBM Phase II study was in newly-diagnosed (unmethylated) patients. As far as I know, to date there is no data on how paxalisib performs in recurrent GBM.

COMMENT : Historical GBM studies have been on recurrent GBM. Accordingly, the Kazia Phase 2 study, was reported on an intent to treat basis. KAZIA  "Median overall survival (OS) in the intent-to-treat (ITT) population (n=30) was 15.7 months (11.1 – 19.1), which compares very favourably to 12.7 months historically reported with temozolomide in this patient group."
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The 15 months-mark is very specific to the indication and population.
Your view of "But the view of this high profile research is that 15 months in new or subsequent studies, is good enough." is too generalising.

COMMENT: The study itself specifically nominated 15 months as a target OS.

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Patients with newly-diagnosed methylated GBM already have a median OS of around 22 months. Achieving 15 months in this GBM population would be meaningless.

COMMENT: Paxalisib studies focus on unmethylated GBM.

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Lastly, let's assume paxalisib replicates the phase II results and demonstrates a median OS of 15-16 months in the newly-diagnosed, unmethylated population. If the TMZ control arm demonstrated the same results, chances for paxalisib's regulatory approval in this population would be very slim. In the end it will come down to the difference between both arms, not the absolute number

COMMENT: This expansive research, in the context of my post is highly relevant. Would you prefer it not be posted ....and wait for more control results. Indeed, this research - released only in January last, could be supportive of likely replication of historic control results in GBM AGILE. (especially given its authors)