Dr Wen and others from GBM AGILE - previously discussed
"Pooling data from chemotherapy, biologics, and immunotherapy trials, a meta-analysis indicated a strong correlation between ORR and mOS (R2=0.3164, P< 0.0001; mOS[weeks]=0.6xORR+28.9), suggesting an ORR >20% results in an mOS of > 40.9 weeks, which is double the survival estimate of a treatment with ORR=0% and ≥ 2 months longer than treatments with ORR=5%. Assuming an ineffective therapy (control) has ORR=5%, a trial of 32 patients with a target ORR=20% leads to the 95% confidence interval higher than the control group. We conclude that single arm phase II studies in recurrent GBM with ≥ 32 patients should have a target ORR ≥ 20%. This was associated with a median OS of approximately 1 year"
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Just back to that study from the senior GBM AGILE researchers. (The stakes are extremely high for KZA investors - this really is the stuff of "El DORODO" . But have to wait and see, I guess. )
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The quoted "median OS of approximately 1 year"......exactly matched the paxalisib GBM Phase 2 study OS, to the week in fact...... using the time for commencement of treatment. Quoted in the paxalisib abstract is a medium time of 3.75 months to start of treatment. See below.
I have read more studies in future will be quoting - start of treatment times, rather than from disease diagnosis.
The unusual small number of patients in this paxalisib Phase 2 study - gives it away. All the goggling in the world, and the identical OS dates quoted, only serves to confirm - the study referred to is Paxalisib phase 2.
So as of November - paxalisib is the standard - the gold standard to which other drugs must aspire to. A great endorsement for paxalisib.
The GBM AGILE has been underway for 3 years - with and paxalisib joining some 22 months ago. Forever and a day now - it has been determined that TMZ in unmethylated GBM effectively does not work. The information presented by the company previously in that post Paxalisib Phase 2 study verse TMZ, was correct and appropriate.
I suspect that the November historical study - is exactly what has been replicated by Paxalisib, over the last 2 years. Probably otherwise , why is it being used now (Nov) ?
Other drugs in GBM AGILE :
Bayers Regorafenib is conclusively out of GBM AGILE and VAL-083 from Kintara Therapeutics.....post their entry into AGILE, released poor Phase 2 GBM study results from their own study mid year. (More maybe on Regorafenib and VAL - 083 at a later time - or better still maybe somebody else can research and contribute on them). Interesting that Kintara Therapeutics - also now use time from commencement of treatment in their studies also.... rather than time of diagnosis.
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Paxalisib in patients with newly diagnosed glioblastoma with unmethylated MGMT promoter status: Final phase 2 study results.
Patrick Y. Wen, John Frederick de Groot, James Battiste, Samuel A.
Goldlust, James Stuart Garner, John Friend, ...
Efficacy analyses are based on investigator review and from date of diagnosis. Results: Patients (n = 30; 70.0% males, 83.3% white, mean age 58.5 years) had a mean time since diagnosis of 3.75 months........and the median overall survival was 15.7 months. (ie 12 months from commencement of treatment)
KZA Price at posting:
9.2¢ Sentiment: Buy Disclosure: Held
