NEW YORK – Kazia Therapeutics on Thursday began a Phase II trial of its lead candidate paxalisib in patients with IDH-mutant grade 2 and 3 gliomas.
In the study, called LUMOS2, researchers will evaluate paxalisib, Kazia's PI3K/AKT/mTOR inhibitor, and other targeted therapies in adult patients with grade 2 or 3 IDH-mutant gliomas. The trial will be sponsored by the University of Sydney and coordinated by Australia's National Health and Medical Research Council Clinical Trials Centre and the Cooperative Trials Group for Neuro-Oncology (COGNO).
LUMOS2 will include up to 76 patients with IDH-mutant glioma who have had prior treatment with radiotherapy and alkylating chemotherapy. The primary endpoint of the trial is six-month progression-free survival, and secondary endpoints include overall survival, response rate, and health-related quality of life.
"Relapsed IDH-mutant gliomas are an important area of unmet need in brain cancer, and the LUMOS2 study builds on early Phase II data seen with paxalisib in this population," said Hui Gan, lead investigator on the study and co-director of the Centre for Research Excellence in Brain Cancer at the Olivia Newton-John Cancer Research Institute in Melbourne. "LUMOS2 will complement some of the ongoing work with paxalisib evaluating the efficacy of the drug in high-grade gliomas, and we expect the study to add substantially to our understanding of this investigational drug in brain cancer."
Paxalisib is also being studied in GBM AGILE, another platform trial evaluating multiple therapies in patients with glioblastoma. Kazia also has ongoing studies of the drug in HER2-positive breast cancer patients with brain metastases, pediatric gliomas, and solid tumors with brain metastases.