IPAX-1 Late Breaking Oral Presentation at the Congress of Neurological Surgeons (CNS) Meeting

MELBOURNE, Australia and INDIANAPOLIS, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) is pleased to announce the first set of peer-reviewed results from the IPAX-1 Ph I/II study of TLX101 (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) in combination with external beam radiation therapy (XRT) in recurrent glioblastoma multiforme (GBM) has been delivered as a late breaking oral presentation at the Congress of Neurological Surgeons (CNS) Annual Meeting currently taking place in Austin, Texas.   

The data confirms the study has met its primary objective, demonstrating safety and tolerability of TLX101 at doses tested. The results also show overall survival (OS) of 15.97 months, to date, in the second line (recurrent) GBM setting. Six (6) out of 10 patients in the study are still alive and will be followed until one (1) year after dosing for the final OS calculation (May 2022).

The primary objective of the study was to evaluate the safety and tolerability of intravenous ¹³¹I-IPA administered concurrently with second line XRT in patients with recurrent GBM. Secondary objectives were to determine optimal dosing, biodistribution and radiation absorption into the tumour, as well as assess preliminary efficacy through clinical and imaging-based assessment of tumour response.

Based on these encouraging results, Telix confirms it intends to progress to a follow-on Phase II study and is currently finalizing the protocol in frontline post-surgery in combination with standard of care and using Telix’s TLX101-CDx (¹⁸F-FET) investigational agent as a companion diagnostic.

Safety Summary and Conclusions

All patients evaluated received similar total activity dose of ~2GBq (2000 MBq) of TLX101, either in a single administration or a triple-fractionated regime. The results demonstrated both dosing regimens, in combination with XRT, were well tolerated:

• Dosimetric analysis demonstrates that radiation exposure to key organs is well within prescribed safety limits.
• The most frequent treatment emergent adverse event (TEAE) was fatigue, which occurred in three patients, followed by diarrhea, decreased lymphocyte count, headache, and cerebral oedema, all of which occurred in two patients.
• With the exception of cerebral oedema (swelling), a common side-effect of radiotherapy to the brain, adverse events typically had an intensity of grade 1 or grade 2. The therapy was generally well tolerated by patients.