Press Release: IPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-Oncology Advances
Neuro-Oncology AdvancesIPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-OncologyAdvances MELBOURNE, Australia, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited(ASX: TLX, Telix, the Company) today announces that the Company's IPAX-1 Phase I studyhas been published in Neuro-Oncology Advances, confirming the safety and tolerabilityprofile, and early efficacy of TLX101 therapy, in combination with external beamradiation therapy (EBRT) in recurrent glioblastoma (GBM), the most common and aggressiveform of primary brain cancer. TLX101 (4-L-[ (131) I] iodo-phenylalanine, or (131) I-IPA) is a systemicallyadministered targeted radiation therapy that targets L-type amino acid transporter 1(LAT1), which is typically over-expressed in GBM. In the first peer-reviewed publication of the IPAX-1 study, Professor Josef Pichler andcolleagues report that single or fractionated doses of TLX101 plus EBRT were associatedwith acceptable tolerability and specific tumor-targeting in patients with recurrent GBM.Authors explain that the study delivered encouraging preliminary efficacy data,demonstrating a median overall survival (OS) of 13 months from the initiation oftreatment, or 23 months from initial diagnosis. Given that GBM has a median survival frominitial diagnosis of 12-15 months, authors conclude that findings from the IPAX-1 study"support further investigation into the use of TLX101 plus EBRT, including its potentialas a first line treatment". Key findings of the IPAX-1 study, outlined in the paper, include: -- All dosing regimens were well tolerated. -- Organ-absorbed radiation doses in the red bone marrow (0.38 Gy) and kidney (1.28 Gy) confirmed no radiation-based toxicity. -- Stable disease with MRI1 assessment was observed in 4 of 9 patients at 3 months post-treatment (3-month follow-up, 1 patient did not reach protocol-mandated end of study), yielding a response rate of 44.4%. -- At the 3-month follow-up, 6 patients demonstrated metabolic stable disease with 18F-FET PET imaging. -- Median progression-free survival was 4.3 months (95% confidence interval, 3.3--4.5), while median OS was 13 months from the initiation of treatment (95% confidence interval, 7.1--27), or 23 months from initial diagnosis. Metabolic tumor responses were determined using Telix's investigational PET(2) agentfor glioma imaging, TLX101-CDx (Pixclara(TM)(3) , (18) F-floretyrosine or (18) F-FET). Professor Josef Pichler, Kepler University Hospital, Austria, Principal Investigator inthe IPAX-1, IPAX-2 and IPAX-Linz studies, and lead author, commented, "A significantunmet need exists for well-tolerated and efficacious treatments for patients withglioblastoma. The results from this Phase I study demonstrate the favorable safety andtolerability profile and preliminary efficacy of TLX101 in combination with second-lineEBRT, in patients with recurrent glioblastoma. Following treatment with TLX101 plus EBRT,stable disease was observed in 44% of patients at 3 months post-treatment and medianprogression-free survival was 4.3 months, with no confirmed radiation toxicity. Theoverall survival improvement trend seen in this patient population clearly warrantsfurther investigation into the use of TLX101 plus EBRT, including its potential as afirst-line treatment. These studies are now well advanced." Dr David N Cade, Chief Medical Officer at Telix said, "We believe that TLX101 hassignificant potential to improve outcomes for patients living with glioblastoma -- adisease in urgent need of new treatment options. In the front-line setting, the standardof care has not advanced materially in almost two decades, and in recurrent disease, nostandard treatment exists. We are encouraged by these data, which show that TLX101, incombination with EBRT, is well tolerated at the doses tested, with preliminary clinicalevidence demonstrating an anti-tumor effect and disease stabilisation - outcomes that arevery important for this advanced patient population. Telix is pleased to be at theforefront of developing a new therapy for glioblastoma, and we welcome the excellent workconducted by Professor Pichler and his colleagues to progress this." The IPAX-2 and IPAX-Linz studies in the front-line and recurrent settings continue toprogress well in combination with standard of care, and using Telix's Pixclara(TM)(3)investigational PET agent as companion diagnostic. Data from IPAX-1, together with thesestudies, will inform the design of Telix's future registration-enabling trial for TLX101.
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