Telix Pharmaceuticals (ASX: TLX) has announced positive interim results from its Phase 2 clinical trial evaluating TLX-250 in patients with metastatic castration-resistant prostate cancer. The data demonstrates a 42% reduction in prostate-specific antigen (PSA) levels at 12 weeks, with a favorable safety profile.
- 42% of patients in the Phase 2 trial achieved ≥50% reduction in PSA levels at 12 weeks
- 29% of patients had stable disease for over 24 weeks
- No treatment-related serious adverse events reported
- Trial includes 38 participants across Australia and the U.S.
- Full data expected by late 2026, with regulatory discussions underway
- Supported by $15 million grant from Australia’s Medical Research Future Fund
Telix Pharmaceuticals (ASX: TLX) has reported interim findings from its ongoing Phase 2 clinical trial assessing TLX-250, a novel radioligand therapy targeting prostate-specific membrane antigen (PSMA) in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial, which enrolled 38 participants across multiple centers in Australia and the United States, showed that 42% of patients achieved a ≥50% reduction in PSA levels at the 12-week evaluation point, a key biomarker for treatment response in prostate cancer. Additionally, 29% of patients experienced stable disease lasting beyond 24 weeks, indicating prolonged clinical benefit in a high-risk population with limited treatment options. The safety profile of TLX-250 remained consistent with prior studies, with the most common adverse events being mild to moderate fatigue (18%) and nausea (13%). No treatment-related serious adverse events were reported, and there were no instances of nephrotoxicity or hematologic toxicity exceeding Grade 2. These results support the potential for TLX-250 to become a well-tolerated, effective option in the mCRPC treatment landscape, particularly for patients who have progressed after standard therapies. The company plans to complete enrollment of the Phase 2 trial by Q2 2026, with full data expected in late 2026. Telix has also initiated discussions with regulatory agencies in the U.S. and Europe regarding a potential path to accelerated approval based on the Phase 2 results. The development of TLX-250 is being supported by a $15 million grant from the Australian Government’s Medical Research Future Fund, underscoring its strategic importance in advancing precision oncology solutions.