ProstACT Global Phase 3 study (part 1) achieves primary objectives

CAR-T Digest - August 2020

10 March 2026: ProstACT Global Phase 3 study (part 1) achieves primary objectives

Telix Pharmaceuticals announced that Part 1 of the global Phase 3 ProstACT Global trial evaluating its investigational radioligand therapy TLX591-Tx (lutetium-177 rosopatamab tetraxetan) has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed
The safety and dosimetry lead-in phase enrolled 36 patients with PSMA-positive metastatic castration-resistant prostate cancer who had previously received an androgen receptor pathway inhibitor and evaluated TLX591-Tx in combination with standard therapies including enzalutamide, abiraterone, or docetaxel
Results showed that the therapy was generally well tolerated, with mostly low-grade non-hematologic adverse events such as fatigue, nausea, and dry mouth, while hematologic events were transient and manageable and consistent with expectations for this therapeutic class
Dosimetry analysis confirmed favorable biodistribution, with radiation exposure to key organs remaining below safety limits and consistent tumor uptake observed across treatment cohorts, alongside pharmacokinetic data indicating sustained tumor retention
With the successful completion of Part 1, Telix has advanced the ProstACT study into Part 2, a randomized treatment expansion comparing TLX591-Tx plus standard of care versus standard therapy alone, while preparing to submit the results to the U.S. FDA to support further clinical development