Excellent interim DIPG data from PNOC, page-7

I am basing my view on three things
1) not graduating to stage 2 of the trial
2) paxalisib being tested in recurrent patients though there is no treatment experience in this patient population and splitting patients across two groups reduces the power / probability to meet the primary endpoint in the unmethylated, newly diagnosed group
3) VAL-083 not being able to show a benefit over SOC - the results from its single-arm Phase II data where in the range of paxalisib’s results

Existing Phase II data for paxalisib in GBM only showed a treatment benefit in PFS and mOS vs TMZ data in historical control - the pivotal trial data was used (mOS: 12.7 months I believe). But the results with TMZ-based therapy in other trials range up to 15 months for mOS.

And looking at the market reaction after the GCAR announcement of paxalisib not graduating it is not only “some” who think it is less likely.

I am still hopeful that the results in the harder unmethylated sub-population are good enough to pull it off. And the fact that Kazia does not have the results, yet, when Kintara already does even though both started roughly at the same time feeds the hope that it is less clear cut (not a straight “no”) and the in-depth analyses are just taking more time.