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.
KZA Price at posting:
$1.45 Sentiment: Buy Disclosure: Held