Study on TLX101 Glioblastoma Therapy Published in Neuro-Oncology Advances

Telix Pharmaceuticals Limited has announced the publication of its IPAX-1 Phase I study results in Neuro-Oncology Advances, highlighting the promising safety and efficacy of TLX101 in combination with external beam radiation therapy (EBRT) for treating recurrent glioblastoma (GBM). GBM is a highly aggressive form of primary brain cancer, and TLX101, also known as 4-L-[131I] iodo-phenylalanine or 131I-IPA, is a targeted radiation therapy that focuses on LAT1, a protein frequently overexpressed in GBM tumors.

The study, led by Professor Josef Pichler and his team, demonstrates that TLX101, when combined with EBRT, shows acceptable tolerability and effectively targets tumors in GBM patients. The study's preliminary efficacy data is encouraging, showing a median overall survival (OS) of 13 months from the start of treatment and 23 months from initial diagnosis. Considering that the median survival for GBM from diagnosis is typically 12-15 months, these findings suggest significant potential for TLX101 as a promising treatment option.

Key findings from the IPAX-1 study include:
- The safety profile of all dosing regimens was well established.
- Radiation doses absorbed by organs such as the red bone marrow and kidneys were within safe limits, with no radiation-related toxicity observed.
- MRI assessments at three months post-treatment indicated stable disease in four out of nine patients, yielding a 44.4% response rate.
- PET imaging with 18F-FET showed metabolic stable disease in six patients at the three-month follow-up.
- Median progression-free survival was recorded at 4.3 months, while the median OS from treatment initiation was 13 months.

The use of the investigational PET agent TLX101-CDx (Pixclara®, 18F-floretyrosine or 18F-FET) was crucial in determining metabolic tumor responses. Professor Pichler emphasized the urgent need for effective and well-tolerated treatments for GBM patients, noting that the results from this Phase I study are crucial. He highlighted the favorable safety and efficacy profile of TLX101 combined with EBRT, indicating no confirmed radiation toxicity and stable disease in 44% of patients at the three-month mark. The improvement in overall survival underscores the potential of TLX101 as a first-line treatment.

Dr. David N Cade, Chief Medical Officer at Telix, echoed these sentiments, stating that TLX101 has substantial potential to improve outcomes for GBM patients, a condition that lacks advanced treatment options. The preliminary data showing an anti-tumor effect and disease stabilization is promising, and Telix is committed to advancing this therapy.

The IPAX-2 and IPAX-Linz studies are progressing well, combining TLX101 with standard care for both front-line and recurrent GBM settings. These ongoing studies, along with the data from IPAX-1, will guide the design of Telix's future registration-enabling trial for TLX101.

TLX101 aims to address significant unmet needs in brain cancer treatment, utilizing a small molecule approach to cross the blood-brain barrier, which is crucial for drug delivery to the brain. It has received orphan drug designation in the U.S. and Europe for glioma treatment.

Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing radiopharmaceuticals for therapeutic and diagnostic purposes. Based in Melbourne, Australia, Telix operates internationally and aims to address significant medical needs in oncology and rare diseases. Telix’s leading imaging product, Illuccix®, has been approved by regulatory bodies in the U.S., Australia, and Canada. The company continues to innovate in the field of radiopharmaceuticals, striving to improve patient outcomes across various conditions.