Ivy Brain Tumor Center Announces Interim Results of Two Clinical Trials Targeting High-Grade Glioma
Results to be presented at 2023 ASCO Annual Meeting
PHOENIX, ARIZ., June 2, 2023 – The Ivy Brain Tumor Center at Barrow Neurological Institute, the nation’s largest early-phase drug development program dedicated to brain cancer, is reporting initial results to the American Society of Clinical Oncology (ASCO) for two Phase 0 clinical trials of infigratinib and niraparib in recurrent high-grade glioma and newly-diagnosed glioblastoma, respectively. A Phase 0/1b clinical trial was selected for presentation and withdrawn pending resolution of outstanding patent details.
Abstracts from the clinical trials of infigratinib and niraparib are now online in the ASCO Meeting Library and will be presented by Ivy Center investigators on June 3, 2023 at the ASCO Central Nervous System Tumors poster session.
In a Phase 0 clinical trial of infigratinib, drug penetration and target modulation were assessed in recurrent high-grade gliomas carrying FGFR1 K656E or FGFR3 K650E mutations or the FGFR3-TACC3 translocation. A recent Phase 2 study of infigratinib in recurrent glioblastoma showed no survival benefit and our Phase 0 study suggests this inefficacy was driven by limited levels of tumor penetration and by poor target modulation. These new results do not support the continued clinical development of infigratinib in adult glioma patients.
In another Phase 0 clinical trial, newly-diagnosed glioblastoma patients without O6-methylguanine methyltransferase (MGMT) methylation received the PARP1/2 inhibitor, niraparib, plus fractionated radiotherapy. All patients achieved high drug levels in tumor tissue, in excess of any other studied PARP inhibitor. This early pharmacokinetic signal, along with accompanying pharmacodynamic and survival data, support the accelerated clinical development of niraparib in newly-diagnosed glioblastoma patients.
“The use of Phase 0 clinical trials in neuro-oncology has never been more critical,” says Nader Sanai, MD, director of the Ivy Brain Tumor Center and director of neurosurgical oncology at Barrow Neurological Institute. “These new studies identify one agent that should be phased out of brain tumor drug development while highlighting another that should be at the center of our efforts to target glioblastoma.”
A third presentation, “A Phase 0/1b Study of AZD1390 plus Radiotherapy in Patients with Recurrent Glioblastoma,” was withdrawn while our partner, AstraZeneca, resolves some outstanding patent details. This Phase 0/1b trial remains open to recurrent glioblastoma patient enrollment and will be presented at another upcoming medical conference.
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.