Telix Releases ProstACT Global Phase 3 Study Status

Telix Pharmaceuticals recently provided an update confirming the current status of ProstACT Global, the Phase 3 study evaluating its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosopatamab tetraxetan) in patients with metastatic castration-resistant prostate cancer (mCRPC).

ProstACT Global is the first Phase 3 trial to assess a PSMA-targeted radio antibody-drug conjugate (rADC) administered alongside Standard of Care (SOC)—abiraterone, enzalutamide or docetaxel—compared with SOC alone.

Telix confirmed it has completed patient enrolment for Part 1 of the study, which serves as a safety and dosimetry lead-in and is being conducted in line with the protocol. The company is now preparing for data lock and readout, which will include results from all three Part 1 cohorts, including the docetaxel cohort, the final cohort to complete enrolment.

As previously disclosed, Telix plans to present Part 1 data to the U.S. Food and Drug Administration (FDA) to determine eligibility for U.S. patient participation in Part 2, the randomized treatment expansion phase. Telix said preliminary Part 1 results will be publicly released at the time of readout and FDA engagement.

In line with the protocol, an Independent Data Monitoring Committee (IDMC) reviewed available Part 1 data and recommended the study proceed to Part 2. Telix has advanced ProstACT Global into Part 2 in jurisdictions where approvals have been secured, based on Part 1 indicating no unexpected safety findings or clinical characteristics differing from prior experience.

Part 2 has dosed its first patients and is approved and open for enrolment in Australia, New Zealand, and Canada. Telix also reported regulatory approval to commence in China, Singapore, Türkiye, the United Kingdom, South Korea and Japan. The company intends to file a clinical trial application with the European Medicines Agency (EMA) to support expansion into EU sites.