ProstACT Update: TARGET Study Ethics Approval

Melbourne (Australia) – 12 April 2022. Telix’s ProstACT TARGET Phase II clinical trial of prostate cancer antibody therapy candidate TLX591 has been granted Human Research Ethics Committee approval.

Telix is pleased to announce its ProstACT TARGET Phase II clinical trial of the Company’s prostate cancer antibody therapy candidate TLX591 (177Lu-DOTA-rosopatamab), in patients experiencing a first recurrence of prostate-specific antigen (PSA) after initial therapy for prostate cancer, has been granted Human Research Ethics Committee (HREC) approval.

Telix’s primary goal with the ProstACT study series is to complete the pivotal Phase III ProstACT GLOBAL study in a second-line setting in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing on first-line novel androgen agents. The inclusion of the TARGET study, will generate data on the use of TLX591 in patients at an earlier stage in their prostate cancer, supporting potential future indication expansion. This is in line with Telix’s vision to benefit men along the full spectrum of their prostate cancer journey, creating multiple opportunities to deliver insights into the clinical performance of TLX591 throughout the program duration. As an antibody-based radiopharmaceutical, TLX591 is given as just two doses, two-weeks apart, and requires much less lutetium to deliver long-lasting radiation to the tumour with potential to reduce costs and off-target side effects such as salivary gland toxicity.

ProstACT TARGET is a Phase II single arm study in Australia in 50 patients with prostate-specific membrane antigen (PSMA) -avid biochemically recurrent oligometastatic (five or less metastases) prostate cancer, in combination with external beam radiation therapy (EBRT)​. The clinical objectives are delaying disease recurrence and thus deferring the commencement of androgen deprivation therapy (ADT) with the primary endpoint biological progression-free survival (PFS BIO). The study is a collaboration with Telix’s strategic partner, GenesisCare.

Telix Group CEO and Managing Director, Dr. Christian Behrenbruch stated, “We are delighted to have been granted approval to commence the Phase II ProstACT TARGET study for TLX591, a key milestone in the ProstACT family of trials. TARGET is part of the Company’s long-term clinical and commercial strategy to develop TLX591 across multiple points from men with early, localised disease all the way through to advanced metastatic disease, integrating molecularly targeted radiation (MTR) with standard of care at each stage in the patient journey. Alongside the ProstACT SELECT study, this program will add value and clinical insight to the platform, with opportunity for near-term data readouts.”

GenesisCare Global Chief Medical Officer, Wally Curran MD, added, “It is a privilege to partner with Telix on the Phase II ProstACT TARGET study, a trial which brings hope to thousands of men living with prostate cancer in Australia and worldwide.  Leveraging our global network of treatment centres, we look forward to commencing patient enrolment and helping Telix develop and rapidly scale a bold new approach to prostate cancer therapy.”

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