Let's not forget that this trial was a single arm monotherapy treatment trial.
"The phase II study was conducted in 30 patients at six centres in the United States. It was a
single arm study in which all patients receivedpaxalisib as a monotherapy. As such, all data
must be interpreted in the context of historical comparators. Specifically, Kazia has referred
to the pivotal study of temozolomide, the only existing FDA-approved drug for this patient
population. Such comparisons are always inexact, and this study was not designed either to
precisely quantify the benefit associated with paxalisib or to demonstrate statistical
significance. Rather, these are among the objectives of the ongoing GBM AGILE pivotal trial."
The trial data confirms earlier data which suggests that Paxalisib provides a significant improvement of outcomes for this patient population. Let's not forget that there are many other potential benefits to Paxalisib being investigated including DIPG and as a therapy in other cancers that might help prevent metastasis to the brain.
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Let's not forget that this trial was a single arm monotherapy...
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