Telix Pharmaceuticals (ASX:TLX) has announced 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).
The company said the results were delivered as a late-breaking oral presentation at the Congress of Neurological Surgeons (CNS) Annual Meeting currently taking place in the US.
It said the data confirms the study has met its primary objective, demonstrating the 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 out of 10 patients in the study are still alive and will be followed until one 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.
Telix said it intends to progress to a follow-on Phase II study and is currently finalising 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.
Telix chief medical officer Dr Colin Hayward said, “Whilst a single arm study, the overall survival demonstrated in this initial patient population is encouraging. GBM has a median survival from initial diagnosis of 12-15 months, so the prospect of potentially improved OS in the second-line setting warrants further investigation in a larger patient cohort, including earlier stage patients.”