Telix’s Phase 3 ProstACT Global study is set to present preliminary safety and dosimetry results from its 36-patient lead-in at ASCO 2026. The study focuses on the PSMA-targeted lutetium-177 radioconjugate TLX591-Tx in patients with PSMA-positive metastatic castration-resistant prostate cancer. The dataset covers tolerability, biodistribution, and organ dose estimates, with no efficacy outcomes disclosed before the session.
The study marks Telix’s progression of an antibody-based radiotherapeutic into a two-part Phase 3 program. Part 1, which is now complete, informs dose, schedule, and safety management, while Part 2 aims to enroll approximately 490 patients globally. These patients will have progressed on one androgen receptor pathway inhibitor and will be selected using PSMA PET imaging. The trial is designed to reflect routine practice and enable broad geographic uptake if successful.
Telix’s strategic approach differentiates itself in the PSMA radioligand market by using an antibody chassis with expected pharmacokinetic advantages. This move positions Telix to leverage its existing imaging infrastructure for therapeutic purposes. The study will focus on safety and operational simplicity to justify adoption in a competitive treatment landscape.
Key points to watch at ASCO include hematologic events, adverse effects consistent with the antibody’s pharmacology, organ dose distributions, and patient treatment completion rates. The study’s outcome will determine the feasibility of Telix’s Phase 3 expansion.
[Context: Telix’s Phase 3 ProstACT Global study will present initial safety and dosimetry results at ASCO 2026, focusing on a PSMA-targeted radioconjugate in prostate cancer patients.] [Fact Check: The study aims to differentiate itself in the PSMA radioligand market by using an antibody-based approach with potential pharmacokinetic advantages.]
