Kazia Therapeutics Limited released results on Wednesday from the GBM-AGILE Phase 2/3 study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma, a type of brain cancer. 

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There were 313 newly diagnosed unmethylated (NDU) patients and recurrent patients randomized in Stage 1 to either a paxalisib treatment arm (60 mg/day) or the SOC concurrent control arm from January 2021 to May 2022. 

“We are excited to have shown a 3.8-month improvement in overall survival, an approximate 33% improvement, for newly diagnosed unmethylated patients with GBM compared to the concurrent standard of care arm,” Kazia CEO Dr. John Friend stated.

For the primary analysis, the median Overall Survival (OS) was 14.77 months for paxalisib-treated NDU patients (n=54) versus 13.84 months for cumulative SOC NDU patients (n=75).

For a prespecified secondary analysis in the NDU patients, the median OS was 15.54 months in the paxalisib arm (n=54) versus 11.89 months for concurrent SOC (n=46).

In addition, a prespecified sensitivity analysis in NDU patients showed a similar median OS difference between paxalisib-treated patients (15.54 months) and concurrent SOC patients (11.70 months).

The secondary analysis results are consistent with the previously reported company-sponsored phase 2 study, where the median OS was 15.7 months (n=27) for paxalisib-treated NDU patients compared to 12.7 months historically reported with temozolomide in this patient group.

Paxalisib was well tolerated in GBM-AGILE, and no new safety signals were identified in this patient population.

An efficacy signal was not detected in the recurrent disease population (median OS of 9.69 months for concurrent SOC (n=113) versus 8.05 months for paxalisib (n=100).

Similar results in this population have been reported in the other two drug candidates that have completed the GBM AGILE trial.

Kazia is currently pursuing further analyses of this data to elucidate potential signals for further consideration.

Kazia will request a meeting with the FDA to discuss the results and determine if a potential path to accelerated approval is appropriate for paxalisib. 

Earlier this year, the company announced the early conclusion based on safety and clinical response findings observed to date of an important two-part Phase 1 trial.

KZIA Price Action: Kazia Therapeutics ( KZIA ) shares are up 298.44% at $0.77 at last check Wednesday.

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