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Telix Announces Positive rPFS Data from ProstACT SELECT Trial of TLX591 rADC Therapy Candidate in Prostate Cancer
Nat Lenzo , MD, Nuclear Oncologist and General Internal Medicine Physician and lead recruiter onto the SELECT trial, commented, "We are encouraged by this rPFS result, which compares favourably to small molecule radioligand therapy (RLT) Phase I and II studies at similar stages of development . This is a compelling signal of the potential efficacy of TLX591 in this heavily pre-treated population. The results further support the development of this candidate in an earlier mCRPC patient population which is the focus of the ProstACT GLOBAL Phase III trial and where there remains significant unmet need for effective treatment."
Dr David N. Cade , MD, Group Chief Medical Officer at Telix, stated, "TLX591 is a radio-ADC with significant potential advantages compared to small molecule radiopharmaceuticals in treating prostate cancer. TLX591 is differentiated by a patient-friendly dosing regimen with far lower cumulative radiation exposure compared to small molecule radioligand therapies . This positive signal of efficacy from SELECT builds on prior studies that demonstrated the potential for TLX591 to deliver improved quality of life and durable tumour control in this advanced patient population ."
TLX591 is being further evaluated in the Phase III ProstACT GLOBAL trial in first and second line mCRPC, which is now preparing to enrol patients at its first U.S. sites. This innovative trial design allows physicians a choice of androgen receptor inhibition or docetaxel chemotherapy, thus integrating with real-world standard of care, reflective of Telix's continued innovation in prostate cancer care and commitment to patient outcomes.
TLX591 (INN: lutetium Lu 177 rosopatamab tetraxetan) is Telix's lead investigational radio antibody-drug conjugate (rADC) for the treatment of mCRPC, composed of a high-specificity PSMA-targeting antibody, chelator linker, and cytotoxic lutetium ( Lu) payload. TLX591 is administered intravenously under a two-dose fractionated regimen, potentially enabling the delivery of a highly targeted and potent dose with improved off-target organ radiation exposure. The mAb-based approach may offer distinct advantages in selectivity, internalisation, and retention time over small molecule RLTs for the treatment of mCRPC.
A total of 242 patients have been treated with TLX591 across eight Phase I and Phase II trials including a previously published Phase II (open-label, single-arm) trial, which reported a 42.3 month OS in 17 patients with advanced mCRPC when TLX591 was delivered under a fractionated dosing regimen .
The purpose of the ProstACT SELECT trial is to evaluate the utility of PSMA-PET imaging with Illuccix® to select patients for TLX591 rADC therapy. The primary objectives are to determine whole body biodistribution and organ radiation dosimetry, and assess the safety and tolerability of TLX591 in patients with advanced mCRPC. Radiographic progression-free survival (rPFS) is a secondary study objective.
Previously reported data from the SELECT trial includes :
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in
Melbourne, Australia , with international operations in
the United States ,
Europe ( Belgium and
Switzerland ), and Japan . Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
Telix's lead imaging product, gallium-68 ( Ga) gozetotide injection (also known as Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) , by the Australian Therapeutic Goods Administration (TGA) , and by Health Canada . No other Telix product has received a marketing authorisation in any jurisdiction.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
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