Ivy Brain Tumor Center Announces Initial Results of Pamiparib in Newly-Diagnosed and Recurrent Glioblastoma at the European Society for Medical Oncology (ESMO) 2022 Congress
Oral presentation on the Phase 0 “Trigger” Trial featured interim data on the pharmacodynamics and pharmacokinetics of the investigational PARP inhibitor and its ability to radiosensitize human glioblastoma tissue
PHOENIX, ARIZ., September 10, 2022 – The Ivy Brain Tumor Center at Barrow Neurological Institute announced today initial results from a Phase 0 clinical trial of pamiparib in newly-diagnosed and recurrent glioblastoma (GBM) in combination with radiation therapy. Pamiparib is an investigational small molecule PARP inhibitor created by BeiGene, Ltd. PARP proteins play an important role in cell survival response to DNA damage and undermine the effects of chemotherapy.
The interim analysis demonstrated that pamiparib is well-tolerated in glioblastoma patients, reaches pharmacologically-relevant concentrations in nonenhancing GBM tissue, and radiation sensitizes ex vivo brain tumor patient tissue.
Nader Sanai, MD, Director of the Ivy Brain Tumor Center and Director of Neurosurgical Oncology at Barrow Neurological Institute, presented the findings during an oral session on CNS tumors at the European Society for Medical Oncology Congress in Paris today.
“The initial results of this Phase 0 study of pamiparib plus radiotherapy are the first of its kind,” said Dr. Sanai. “This study is part of our programmatic efforts to identify drugs that can increase the efficacy of radiation treatment for newly-diagnosed and recurrent glioblastoma patients.”
The Ivy Center’s novel Phase 0 study approach demonstrated that pamiparib is capable of penetrating the blood-brain barrier and reaching the tumor at high levels, one of the most significant challenges in treating brain cancer.
“Part of the reason new drugs have not emerged for glioblastoma in over three decades is that the vast majority are incapable of crossing the blood-brain barrier and getting to patients’ tumors,” he said. “This new Phase 0 study offers another avenue of hope for glioblastoma patients and their families awaiting new, effective therapies.”
The initiation of this study marked the first-ever Phase 0 study to enroll newly-diagnosed GBM patients, in addition to recurrent GBM patients to test PARP inhibitors. It is one of more than a dozen Phase 0 clinical trials the Ivy Center has initiated for patients with glioblastoma and other aggressive brain tumors.
Initial data is based on 20 newly-diagnosed and 14 recurrent glioblastoma patients who enrolled in the clinical trial and received the study drug for four days leading up to a scheduled operation to remove their tumors. Within days of operation, the Ivy Center’s team evaluated the drug’s pharmacokinetics and pharmacodynamics to determine its effects in each patients’ tumor. Nineteen patients with positive results advanced to the expansion phase of the study, which combines therapeutic dosing of pamiparib with radiotherapy.
Pamiparib is an investigational inhibitor of PARP1 and PARP2 discovered by BeiGene scientists. Pamiparib has demonstrated PARP-DNA complex trapping properties and brain penetration in preclinical models and is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies.
To learn more about this Phase 0 clinical trial, including eligibility criteria, visit https://clinicaltrials.gov/ct2/show/NCT04614909.
About Ivy Brain Tumor Center
Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, AZ, is a nonprofit translational research program that employs a bold, early-phase clinical trials strategy to identify new treatments for aggressive brain tumors, including glioblastoma. The Ivy Center’s Phase 0 clinical trials program is the largest of its kind in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development. Unlike conventional clinical trials focusing on single drugs, its accelerated trials program tests therapeutic combinations matched to individual patients. Learn more at IvyBrainTumorCenter.org. Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter, and LinkedIn.