Telix Pharmaceuticals (ASX:TLX) has announced that preliminary results from the Phase 2 IPAX-Linz study of TLX101 in recurrent high-grade glioma support the patient benefit seen in the IPAX-1 study.
IPAX-Linz is a single-arm Phase 2 investigator-initiated trial evaluating the safety, tolerability and preliminary efficacy of TLX101 therapy in combination with external beam radiation therapy. The target population is patients at first or second recurrence with high-grade gliomas, including glioblastoma.
Telix said treatment with TLX101 was well tolerated, with no serious adverse events reported.
"IPAX-Linz demonstrated encouraging preliminary efficacy data, indicating a median overall survival (OS) of 12.4 months from the initiation of treatment with TLX101, or 32.2 months from initial diagnosis," said the company, adding, "This is consistent with the positive efficacy signal generated in the IPAX-1 study in patients at first recurrence, with only one prior resection and treatment with standard chemoradiotherapy.
In comparison, recurrent glioblastoma patients treated with external beam radiation therapy alone have a reported median survival of 9.9 months from treatment.
Telix chief medical officer Dr David Cade said, “These are encouraging results, offering new options for patients with historically poor outcomes. We are grateful to Dr Pichler and his team for building on the IPAX-1 study in a more advanced and complex study cohort that is also representative of a real-world patient population.”
Preliminary results from IPAX-Linz will be presented by principal investigator Professor Josef Pichler at the Nuclear Medicine and Neurooncology Symposium in Vienna in May.