- Gliofocus is a global, registrational, randomized, controlled Phase 3 clinical trial comparing niraparib vs temozolomide in newly diagnosed MGMT-unmethylated glioblastoma patients
- Interim Phase 0/2 study results showed promising brain tumor penetration of niraparib and significant advance in median overall survival beyond the historical control
- Final results of the Gliofocus Study are intended to be provided to regulatory authorities to support the assessment of niraparib as a potential treatment for newly diagnosed MGMT-unmethylated glioblastoma
The Ivy Brain Tumor Center at Barrow Neurological Institute today announced that the first patient has been dosed in the pivotal Phase 3 Gliofocus Study.
Gliofocus is an open-label, randomized Phase 3 trial (NCT06388733) that will compare the efficacy of niraparib, a PARP1/2 selective inhibitor, to temozolomide head-to-head in adult patients with newly diagnosed MGMT-unmethylated glioblastoma. This study, supported by GSK, is expected to enroll 450 participants at more than 100 clinical sites across 11 countries.
As one of the deadliest human cancers, an estimated 250,000 people are diagnosed with glioblastoma each year worldwide 2,3. In approximately 60% of glioblastoma tumors, the MGMT promoter is unmethylated,1 and, for this population, the standard of care first-line chemotherapy, temozolomide, has limited effect with a historical median overall survival of 12.7 months.
Positive interim data from the Ivy Center’s Phase 0/2 clinical trial of niraparib prompted its acceleration to the Phase 3 setting. In the ongoing early-phase trial, niraparib achieved pharmacologically relevant concentrations in excess of any other PARP inhibitor in glioblastoma tumor tissue and led to a median overall survival of 20.3 months, while historically the similar population treated with standard of care has a median overall survival of 14 months 2,3. Safety was consistent with the known safety profile of niraparib and no new concerns were identified.
“The dosing of the first patient in the pivotal Phase 3 Gliofocus Study represents a crucial step forward to potentially transform outcomes for MGMT-unmethylated glioblastoma patients worldwide," says Dr. Nader Sanai, director of the Ivy Brain Tumor Center and the Gliofocus Study Chair. “At the Ivy Center, we are committed to pioneering new standards of care that redefine possibilities in brain cancer treatment.”
For more information on this study, including eligibility criteria, visit NCT06388733.
The Ivy Center is home to the largest Phase 0 drug development program for brain cancer worldwide. Click here for a complete list of Ivy Center clinical trials.
About Niraparib
The drug, niraparib is an oral, once-daily PARP inhibitor with current indications in first-line maintenance for advanced ovarian cancer. GSK continues to assess the potential for niraparib in several pivotal trials across multiple tumor types and in combination with other therapeutics.
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About Ivy Brain Tumor Center
Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, AZ, is a tertiary care and nonprofit translational research program that employs bold, early-phase clinical trial strategies to identify new treatments for aggressive brain tumors, including glioblastoma. Our leading experts in neurosurgical oncology, neuro-oncology, radiation oncology, neuroradiology, neuropathology and neuroscience nursing treat more patients annually than any other brain tumor center in the United States. The Ivy Center’s Phase 0 clinical trials program is the largest in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development. In addition, unlike conventional clinical trials focusing on single drugs, the Ivy Center’s accelerated program tests therapeutic combinations matched to individual patients. We leave no stone unturned in the pursuit of hope and healing. Learn more at IvyBrainTumorCenter.org. Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter, and LinkedIn.
- Taylor JW, Schiff D. Treatment considerations for MGMT-unmethylated glioblastoma. Curr Neurol Neurosci Rep. 2015;15(1):507.
- Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma.
- Annavarapu S, Gogate A, Pham T, et al. Treatment patterns and outcomes for patients with newly-diagnosed glioblastoma multiforme: a retrospective cohort study. CNS Oncol. 2021;10(3):CNS76.
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