Telix Pharmaceuticals Limited (TLX,TLX.AX) announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study.
IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz evaluates the safety, tolerability and preliminary efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT). The target patient population is patients at first or second recurrence with high-grade gliomas (HGG), including glioblastoma.
According to the company, treatment with TLX101 was well tolerated with no serious adverse events reported. IPAX-Linz demonstrated encouraging preliminary efficacy data, indicating a median overall survival of 12.4 months from the initiation of treatment with TLX101, or 32.2 months from initial diagnosis. 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. IPAX-1 reported a median OS of 13 months from the initiation of treatment with TLX101, or 23 months from initial diagnosis. In comparison, recurrent glioblastoma patients treated with EBRT alone have a reported median survival of 9.9 months from treatment.
Telix said it continues to investigate TLX101 in front-line and recurrent settings. IPAX-2, a Phase 1/2 study in front-line glioblastoma in combination with standard of care and using TLX101-CDx as a companion diagnostic, continues to recruit patients.
Telix noted that it has submitted for ethics approval a registration-enabling study of TLX101 in recurrent glioblastoma. Subject to approval this will enable patient enrolment to commence at Australian sites in the second-half of 2025, ahead of international expansion. The company is also on track to submit an IND application in the first-half of 2025, with the goal of commencing the study at U.S. sites in the second half of 2025.
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