The trial will assess adults with recently diagnosed MGMT-unmethylated glioblastoma. Credit: Lightspring / Shutterstock.

The Ivy Brain Tumor Center at Barrow Neurological Institute in the US has announced the dosing of the first subject in the Phase III Gliofocus clinical trial of the PARP1/2 selective inhibitor, niraparib, in adults with recently diagnosed MGMT-unmethylated glioblastoma.

The open-label, randomised trial will assess niraparib’s efficacy against temozolomide, a standard-of-care first-line chemotherapy.

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GSK is supporting the trial, which will involve 450 subjects enrolled at more than 100 clinical sites in 11 countries. 

The Ivy Center’s Phase 0/II trial of niraparib showed positive interim data, leading to the acceleration of the asset to the Phase III study.

In the ongoing early-phase trial, niraparib reached pharmacologically significant concentrations in glioblastoma tumour tissue, surpassing other PARP inhibitors.

Treatment with niraparib resulted in a median overall survival of 20.3 months, compared to the historical median of 14 months for a similar population treated with standard care.

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The safety profile of the asset was in line with already reported data, without any new safety concerns detected.

Niraparib, an oral, once-daily PARP inhibitor, is currently indicated for first-line maintenance in advanced ovarian cancer.

GSK is evaluating niraparib in several pivotal trials across various tumour types and in combination with other therapies.

Ivy Brain Tumor Center director and Gliofocus study chair Dr Nader Sanai said: “The dosing of the first patient in the pivotal Phase III Gliofocus Study represents a crucial step forward to potentially transform outcomes for MGMT-unmethylated glioblastoma patients worldwide.

“At the Ivy Center, we are committed to pioneering new standards of care that redefine possibilities in brain cancer treatment.”