Telix phase 3 trial tests radiopharmaceutical therapy for recurrent glioblastoma
The IPAX BrIGHT trial is evaluating TLX101-Tx with lomustine versus lomustine alone in patients with recurrent glioblastoma.
Telix Pharmaceuticals has dosed the first patient in its phase 3 IPAX BrIGHT trial of TLX101-Tx, also known as iodine-131 iodofalan, for recurrent glioblastoma. Telix said it is the first radiopharmaceutical therapy to enter phase 3 development for the disease.
Austin Health in Melbourne, Australia, dosed the first patient under the supervision of Hui Gan, MD. IPAX BrIGHT is a global, multicenter, open-label study evaluating TLX101-Tx with lomustine compared with lomustine alone.
Eligible patients have radiographically confirmed recurrent glioblastoma at first recurrence. The Victorian Cancer Trials Link lists the study as recruiting and describes the trial as evaluating safety and efficacy in people with first recurrence of glioblastoma.
Telix’s investigational PET imaging agent TLX101-Px, also known as Pixclara, will be used for patient selection and metabolic tumor response assessment in the trial. The company said response will be assessed according to PET RANO 1.0.
TLX101-Tx targets L-type amino acid transporter 1, which is typically overexpressed in glioblastoma. Telix said the small-molecule approach is intended to cross the blood-brain barrier and deliver radiation therapy to the tumor.
Earlier data from the IPAX-1 study reported median overall survival of 13 months from treatment initiation. Preliminary IPAX-Linz data showed median overall survival of 12.4 months from treatment initiation, according to Telix.
Regulatory approvals for IPAX BrIGHT have been received in Australia, Austria, Belgium, and the Netherlands. Telix said additional approvals are being sought.
TLX101-Tx has orphan drug designation in the U.S. and Europe for glioma treatment. Telix said neither TLX101-Tx nor TLX101-Px has received marketing authorization in any jurisdiction.
Company:Telix Pharmaceuticals
About the author
RadiologySignal.com writersEditorial Team
Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
More from this section
Pediatric ED imaging gaps persist by race and insurance status
A cohort study of 857,034 pediatric ED visits found that stronger hospital pediatric capability was not associated with narrower imaging-use differences by race, ethnicity, or insurance status.
Study finds wide variation in chest X-ray AI performance
A head-to-head study of 7 commercial AI devices found sensitivity ranged from 20.8% to 77.8% for lung cancer detection on chest X-rays.
MRI radiomics model predicts colorectal cancer subtype
The multicenter study found an MRI-based machine-learning radiomics score predicted CMS4 colorectal cancer and stratified recurrent metastasis risk.
Contrast tied to higher AKI risk in neonatal ICU study
The retrospective study found higher acute kidney injury rates in neonates exposed to iodinated contrast media, although most cases were stage 1.
Quantum reports early results from MS PET study
The ongoing MGH study is evaluating [18F]3F4AP PET imaging for demyelinated neurons with intact axons in patients with multiple sclerosis.
Cochrane updates prostate cancer screening review
The updated review found PSA screening likely reduces prostate cancer deaths, but evidence remains unclear for newer screening strategies combining PSA, kallikrein testing, and MRI.
Stage 4 breast cancer diagnoses rise over decade
A cohort study of 761,471 people found de novo stage 4 breast cancer incidence increased by 1.2% per year from 2010 to 2021.
SIR backs genicular artery embolization for knee osteoarthritis
The Society of Interventional Radiology issued a position statement supporting genicular artery embolization for symptomatic knee osteoarthritis.
Fluoride, lead co-exposure linked to lower youth BMD
Researchers analyzed NHANES data from 2,378 U.S. children and adolescents who underwent DEXA scans from 2013 to 2016.
Stanford receives $3.9M ARPA-H grant for MR lymphangiography
Stanford Medicine received up to $3.9M from ARPA-H to advance MR lymphangiography. Andreas Loening, MD, PhD, will lead work on faster scans, lymphatic-specific contrast agents, and contrast-free flow assessment.
Bayer PET tracer meets cardiac amyloidosis endpoints
Bayer reported positive topline phase 3 REVEAL results for I-124 evuzamitide, an investigational PET/CT radiotracer for suspected cardiac amyloidosis. The study met its sensitivity and specificity endpoints.
MRx maps brain biomarkers in noncontrast MRI scan
University of Illinois researchers developed multiplexed MRI to map more than 20 brain biomarkers in a single scan using standard clinical MRI systems.