Phoenix, AZ, May 23, 2024 (GLOBE NEWSWIRE) --

• Results will be presented at American Society of Clinical Oncology (ASCO) Annual Meeting
• Median overall survival was 20.3 months, nearly doubling the median OS historically observed with standard of care in similar patient population
• GSK to support the initiation of a global, registrational head-to-head Phase 3 clinical trial of niraparib vs standard of care

The Ivy Brain Tumor Center at Barrow Neurological Institute today announced a clinical readout of a Phase 0/2 ‘trigger’ clinical trial of niraparib in patients with newly diagnosed MGMT-unmethylated glioblastoma. As one of the deadliest human cancers, an estimated 250,000 cases of glioblastoma are newly diagnosed each year worldwide with a current 5-year survival rate of 6.9 percent.¹ In approximately 60% of glioblastoma tumors, the MGMT promoter is unmethylated,² and, for this population, the standard of care first-line chemotherapy, temozolomide, has shown to have limited effect.

The study concluded that 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, a significant advance beyond the historical control of 12.7 months^3,4. Safety was constant with known safety profile of niraparib and no new safety signal was identified. These results will be presented in an oral presentation (Abstract #2002) on June 3, 2024, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

"This hybrid Phase 0/2 study provides simultaneous biological and clinical data identifying niraparib as a best-in-class brain-penetrant molecule with promising radiosensitizer effects in glioblastoma. In less than two years, from concept to completion, our team at the Ivy Center generated proof-of-concept data in partnership with GSK and we are now working to deliver a potential new standard of care for MGMT-unmethylated glioblastoma patients," said Dr. Nader Sanai, director of the Ivy Brain Tumor Center.

The positive results of this supported collaborative study between the Ivy Brain Tumor Center and GSK have prompted the acceleration of the Gliofocus Study, a global, multi-center, open-label, randomized head-to-head Phase 3 trial (NCT06388733) that will evaluate niraparib, a PARP1/2 selective inhibitor, in adult patients with newly diagnosed MGMT-unmethylated glioblastoma compared to temozolomide. The trial is expected to enroll 450 participants at more than 100 clinical sites across 11 countries worldwide.

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.

1.    Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

2. Taylor JW, Schiff D. Treatment considerations for MGMT-unmethylated glioblastoma. Curr Neurol Neurosci Rep. 2015;15(1):507.

3. Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma.

4. 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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• Director of the Ivy Brain Tumor Center and director of neurosurgical oncology at Barrow Neurological Institute