Telix Doses First Patient In Phase 3 IPAX BrIGHT Trial For TLX101-Tx In Recurrent Glioblastoma

Telix announced today that the first patient has been successfully dosed with TLX101-Tx (¹³¹I-iodofalan) in the company’s pivotal Phase 3 IPAX BrIGHT trial. This milestone marks the first time a radiopharmaceutical therapy has advanced to Phase 3 development for glioblastoma, an aggressive and fast-progressing form of brain cancer that continues to present significant unmet clinical needs.

The initial dose was administered at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. The IPAX BrIGHT study is designed as a global, multicenter, open-label clinical trial evaluating the safety and efficacy of TLX101-Tx in combination with lomustine chemotherapy, compared with lomustine alone. The trial will enroll patients who have radiographically confirmed recurrent glioblastoma at their first recurrence, a stage where current therapeutic options are limited and outcomes are typically poor.

The company’s focus on advancing care for glioblastoma patients is driven by the reality that therapeutic innovation in this disease has been minimal. In the past quarter century, only two drugs have received approval from the U.S. Food and Drug Administration (FDA) for glioblastoma, and there is still no standard-of-care treatment for recurrence. This leaves patients with few viable therapy options following initial treatment. TLX101-Tx introduces a new therapeutic approach by targeting LAT1, a transporter that facilitates the passage of the radiopharmaceutical across the blood-brain barrier, enabling delivery of targeted radiation directly into the tumor tissue.

The launch of IPAX BrIGHT builds upon encouraging results from earlier clinical experiences. The Phase 1/2 IPAX-1 trial demonstrated a median overall survival of 13 months from the start of treatment with TLX101-Tx, or 23 months from the time of initial diagnosis. The investigator-initiated IPAX-Linz study produced consistent findings, reporting a median overall survival of 12.4 months after treatment initiation and 32.2 months from diagnosis. Beyond formal clinical studies, TLX101-Tx has also been made available through an early access program in Europe, where 18 patients at first or later recurrence have received treatment, further supporting its potential clinical utility.

Professor Hui Gan, Director of Cancer Clinical Trials at Austin Health, stated that the safety profile and early efficacy signals observed in previous IPAX-1 and IPAX-Linz studies provide strong rationale for advancing TLX101-Tx into the first pivotal radiopharmaceutical trial for recurrent glioblastoma. He noted the considerable lack of effective treatment options currently available to patients and emphasized the importance of continuing to explore this therapeutic modality.

Dr. David N. Cade, Group Chief Medical Officer at Telix, commented that the IPAX BrIGHT trial represents a significant step toward offering a new therapeutic option for individuals affected by glioblastoma. He highlighted the scarcity of meaningful innovation in glioblastoma treatment over recent decades and underscored the potential of TLX101-Tx to become a first-in-class therapy capable of improving patient outcomes in a disease where progress has been exceptionally limited.

The IPAX BrIGHT trial has already received regulatory approval in Australia, Austria, Belgium, and the Netherlands, with additional approvals pending in other regions. Telix’s investigational PET imaging agent for glioma, TLX101-Px (floretyrosine F-18), will support the study by assisting with patient selection and enabling metabolic tumor response assessment in alignment with PET RANO 1.0 criteria.

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