How was this missed by myself/others here - from January 2023.
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One of the more significant pieces of information, that I have seen and presented here. (ever)
From an absolute dream team of world researchers in GBM (including all the key people behind GBM AGILE). This comprehensive and exhaustive research is spelt out for the FDA. Nothing spared, nothing left behind in this study. It could be addressed :
Attn The FDA, when considering new GBM drug applications...as you will see and agree.
If this "dream team" are true to their own research here - its apparent and little wonder Paxalisib in 150 patients, GBM AGILE study, was considered a big enough sample to achieve the goal of exceeding "medium OS of 15 months in a sample size of ≥40 patients, in order to convincingly demonstrate antitumor activity. " .......such being the case, the FDA would surely approve any new drug for treatment of GBM cancer.
NOTE of course, that Paxalisib, exceeded this confirmed goal of OS 15 months, in all of its previous GBM Clinical Trials.
Read for yourself - but keeping it simple - more than 4000 patients in all past GBM Clinical were studied, with results published. Temozolomide I note came out best, in most studies. But the view of this high profile research is that 15 months in new or subsequent studies, is good enough.
The correlation between ORR and overall survival is discussed - but as I say, Paxalisib would strongly exceed the determined OS nominated here in this document.
Match or beat 15 months OS in the GBM data later this year - than truely you have a company worth US$3 BILLION.
Objective response rate targets for recurrent glioblastoma clinical trials based on the historic association between objective response rate and median overall survival
Benjamin M Ellingson, Patrick Y Wen, Susan M Chang, Martin van den Bent, Michael A Vogelbaum, Gang Li, Shanpeng Li, Jiyoon Kim, Gilbert Youssef, Wolfgang Wick, Andrew B Lassman, Mark R Gilbert, John F de Groot, Michael Weller, Evanthia Galanis, Timothy F Cloughesy Neuro-Oncology, noad002, https://doi.org/10.1093/neuonc/noad002
Published:
"........we recommend that well-controlled, single-arm phase II studies in recurrent glioblastoma should have a target ORR >25% (which translates to a median OS of approximately 15 months) and a sample size of ≥40 patients, in order to convincingly demonstrate antitumor activity."
KZA Price at posting:
19.0¢ Sentiment: Buy Disclosure: Held
