Telix Pharmaceuticals announced preliminary positive Phase 2 results for TLX101, a targeted radiation therapy for recurrent high-grade glioma (brain cancer). The IPAX-Linz study reinforced patient benefits observed in the earlier IPAX-1 study, showing a median overall survival of 12.4 months from the start of TLX101 treatment. The therapy was well-tolerated with no reported serious adverse events.
These results are particularly important because they suggest TLX101 could offer a new treatment option for patients with recurrent glioblastoma, a disease with limited effective therapies. The median overall survival observed in the study surpasses the reported 9.9 months for patients treated with external beam radiation therapy alone, the current standard of care for recurrence. This improvement is notable, especially considering that five of the eight patients had MGMT unmethylated tumors, a biomarker typically associated with a poorer prognosis.
The IPAX-Linz study involved eight patients who received adaptive intravenous doses of TLX101, up to 4 GBq before and 2 GBq after external beam radiation therapy. Inclusion criteria included evidence of first or second recurrence, at least six months since prior radiation therapy, and positive results from a PET scan using Telix’s investigational imaging agent, TLX101-CDx.
This positive data supports Telix’s ongoing development of TLX101. The company is currently conducting the IPAX-2 trial in front-line glioblastoma and has submitted for ethics approval for a registration-enabling study in recurrent glioblastoma. Telix also plans to submit an Investigational New Drug (IND) application to the FDA in the first half of 2025, aiming to begin the study in the US later that year. These efforts indicate a clear path toward potential regulatory approval and commercialization, offering hope for a much-needed new treatment option for patients with this aggressive form of brain cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
