Telix Doses First Patient in Phase 3 Trial for Recurrent Glioblastoma Therapy

Telix Pharmaceuticals has announced that the first patient has been dosed in its Phase 3 IPAX BrIGHT trial evaluating TLX101-Tx (¹³¹I-iodofalan), marking the first radiopharmaceutical therapy to enter late-stage development for glioblastoma.

The patient was treated at Austin Health in Melbourne under the supervision of Professor Hui Gan. The global, multicenter, open-label study will assess the safety and efficacy of TLX101-Tx in combination with lomustine chemotherapy, compared with chemotherapy alone, in patients with recurrent glioblastoma at first relapse.

Glioblastoma remains one of the most aggressive forms of brain cancer, with limited treatment options. Over the past 25 years, only two drugs have received U.S. FDA approval for the disease, and no standard therapy exists for recurrence. TLX101-Tx aims to address this gap by targeting the L-type amino acid transporter 1 (LAT1), enabling the therapy to cross the blood-brain barrier and deliver radiation directly to tumor cells.

The Phase 3 trial builds on encouraging earlier data. The IPAX-1 study reported a median overall survival of 13 months from treatment initiation (23 months from diagnosis), while the IPAX-Linz trial showed similar results, with a median survival of 12.4 months from treatment and 32.2 months from diagnosis. Additionally, 18 patients have received the therapy through a European early access program.

“Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options,” said Professor Gan, Director of Cancer Clinical Trials at Austin Health.

Telix’s Group Chief Medical Officer, Dr. David N. Cade, added, “Through the IPAX BrIGHT trial, we aim to offer a new option for patients affected by glioblastoma. This registration-enabling study represents a major step forward in our mission to improve therapeutic options in neuro-oncology.”

The trial has received regulatory approval in several countries, including Australia, Austria, Belgium, and the Netherlands, with additional approvals pending. Telix will also use its investigational PET imaging agent, TLX101-Px, for select patients and to assess tumor response.