Telix Commences Phase III Clinical Trial of Prostate Cancer Therapy

Melbourne (Australia) – 10 May 2021. Telix has been granted HREC approval and received CTN clearance by the TGA to commence a Phase III study of the Company’s prostate cancer therapy candidate TLX591, in patients with advanced prostate cancer.

Telix is pleased to announce it has been granted Human Research Ethics Committee (HREC) approval and received Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to commence a Phase III clinical trial of the Company’s PSMA targeted prostate cancer therapy candidate TLX591 (¹⁷⁷Lu-DOTA-rosopatamab), in patients with advanced metastatic castrate-resistant prostate cancer (mCRPC).

The Phase III “ProstACT” trial is an international, multi-centre, randomised controlled trial in patients with PSMA-expressing mCRPC, experiencing disease progression following prior treatment with a novel androgen axis drug (NAAD). The ProstACT trial will enrol approximately 390 patients and incorporates patient selection using ⁶⁸Ga-PSMA imaging with TLX591-CDx (Illuccix^®). The trial will compare standard of care therapy alone versus standard of care therapy plus TLX591, with a primary endpoint of radiographic progression-free survival (rPFS). Trial secondary endpoints will include overall survival and quality-of-life assessment. Telix has commenced the initiation of Australian ProstACT trial sites and will add global sites progressively during the second half of 2021, subject to the requisite approvals.

Telix Chief Executive Officer Dr. Christian Behrenbruch stated, “The commencement of the ProstACT Phase III study for TLX591 marks a major corporate milestone for Telix that brings the Company a step closer to delivering on a major unmet medical need for treatment options in this patient population. ProstACT builds on a significant body of clinical data for TLX591, which to date has been studied in over 200 patients with advanced prostate cancer, across five previous studies. TLX591 has demonstrated promising and competitive clinical potential that we believe warrants further confirmation in this second-line disease setting. It is also noteworthy that Telix’s differentiated approach to integrating molecular imaging with PET alongside therapy, enables a comparatively streamlined study that we believe will support efficient patient enrolment and study execution.”

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