ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives
Webcast and conference call to be held today, Tuesday March 10 at 9:30 a.m. AEDT (Monday March 9 at 6:30 p.m. EDT). Investors can register at the following link: https://s1.c-conf.com/diamondpass/10053620-ju7y6t.htmlMELBOURNE, Australia and INDIANAPOLIS, March 10, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.Key findings include:Tolerability profile supported by dosimetry and low-grade non-hematologic events.Lesion dosimetry indicates no difference in absorbed dose profile across cohorts.No adverse drug-drug interactions observed in TLX591-Tx combinations.Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts.The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy.Part 1 of the study confirmed the safety profile, biodistribution and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with one of three standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI).ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted 177Lu-rADC therapy administered with SOC versus SOC alone, a trial design intended to reflect current global clinical practice1. Telix has already advanced the study into Part 2 – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities2. Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S.Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, "These results reinforce the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC, including ARPIs such as enzalutamide or abiraterone, or docetaxel. Hematologic events align with those typically seen in this patient population and therapeutic class, and these cases resolved quickly. The dosimetry profile, along with the low-grade nature of non-hematologic adverse events, further supports the tolerability profile of this investigational therapy."David N. Cade, MD, Group Chief Medical Officer, Telix added, "Despite advances in clinical practice, men with advanced prostate cancer still need improved first and second line treatment options. These results build on prior findings and highlight the potential for TLX591-Tx in combination with contemporary standard of care, to become a new first-line option for patients facing this aggressive disease. We are encouraged by the data and look forward to engaging with the FDA at the earliest opportunity, while continuing to advance enrollment in Part 2 in regions where clinical trial initiation has already been approved."Summary resultsProstACT Global Part 1 dosed 36 patients, allocated across 3 cohorts:Cohort 1 (11 patients): TLX591-Tx + enzalutamide.Cohort 2 (11 patients): TLX591-Tx + abiraterone.Cohort 3 (14 patients): TLX591-Tx followed by docetaxel.Safety and tolerabilityAn acceptable safety profile was observed across combination cohorts and tolerability of TLX591-Tx was consistent with prior studies.All 36 patients received both doses of TLX591-Tx per protocol, no new safety ...Full story available on Benzinga.com
2026-03-09 23:19:56