Ivy Blog
Ivy Brain Tumor Center Hosts European investigator meeting for Gliofocus Study
Lead investigators in the Gliofocus Study, a global Phase 3 clinical trial testing a new treatment for glioblastoma, met last month in Madrid, Spain, to discuss successes and challenges as the trial expands worldwide.
The Ivy Brain Tumor Center and 48 other international clinical trial sites converged at the Gliofocus European Investigator Meeting.
The meeting served as an opportunity for all investigators involved in the Gliofocus Study to review the trial’s objectives and procedures. Investigator meetings play a key role in keeping all researchers aligned and ensuring that the trial is conducted smoothly and consistently across sites.
The European meeting followed a North American investigator meeting in January and brought together 136 participants from 11 countries, in addition to the United States and Canada. Representing the Ivy Center were Director Nader Sanai, MD; Chief Medical Officer Yoshie Umemura, MD; Deputy Director and Chief Scientific Officer Shwetal Mehta, PhD; Global Medical Director David Jackson, MD, MBA; and Operations Director Jocelyn Harmon.
Reflecting on the significance of the meeting, Dr. Sanai shared, “This room represents one team around the globe working to find a new treatment option and change the reality for patients with newly diagnosed, unmethylated tumors.”
The Gliofocus Study, which is sponsored by the Ivy Brain Tumor Center at Barrow Neurological Institute, launched in June 2024 and aims to enroll 450 participants across more than 115 clinical sites. As an open-label, randomized controlled trial, Gliofocus is designed to determine whether the drug niraparib improves progression-free survival and overall survival of adults with newly diagnosed, MGMT-unmethylated glioblastoma compared to temozolomide, the gold standard chemotherapy drug for these tumors.
Niraparib is a potent and selective inhibitor of PARP1 and PARP2. PARP enzymes help repair damage done by chemotherapy in the DNA of cancer cells. In a Phase 0/2 clinical 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.
Dr. Mehdi Touat expressed optimism about the trial’s potential, stating, “We are excited to assess niraparib in newly diagnosed glioblastoma, building on promising findings from early phase and preclinical studies. This trial holds significant potential to improve outcomes for patients with MGMT unmethylated glioblastoma.”
An estimated 250,000 people worldwide are diagnosed each year with glioblastoma, one of the deadliest human cancers. In approximately 60% of glioblastoma tumors, the MGMT promoter is unmethylated. This genetic profile is associated with resistance to temozolomide treatment, with median overall survival of 12.7 months for these patients.