Ann: ProstACT SELECT Study of TLX591 rADC Therapy - Positive rPFS, page-61

As Interpreted by AI

Key Takeaways

The ProstACT SELECT study of TLX591, a novel radio-antibody drug conjugate (rADC) therapy for metastatic castration-resistant prostate cancer (mCRPC), has shown positive interim results:

• The study achieved its primary objectives, confirming the safety and tolerability of TLX591 when administered in two doses, two weeks apart, in combination with standard of care (SoC).
• Preliminary data demonstrates meaningful reduction in prostate-specific antigen (PSA) levels, indicating potential anti-tumor activity. Monitoring of patients for radiographic progression-free survival (rPFS) is ongoing.
• The short, fractionated dosing regimen (two doses over two weeks) reinforces the clinical utility and potential advantages of TLX591 as a first-in-class rADC therapy.

Potential Advantages of TLX591

• As an antibody-based approach, TLX591 offers different targeting and pharmacology compared to small molecule PSMA inhibitors, potentially maximizing cell-killing effect at tumor sites.
• The therapy demonstrated consistent lesion delineation and high tumor binding, while minimizing uptake in critical organs like the kidneys, potentially reducing side effects.
• Experts highlight the attractive treatment duration, tolerability profile, and potential for reduced undesirable side effects compared to other PSMA-targeting radiotherapies.

Next Steps

• Telix is continuing to investigate TLX591 in the Phase III ProstACT GLOBAL study, which has recently dosed its first patient. This pivotal trial will evaluate TLX591 in combination with SoC versus SoC alone in PSMA-positive mCRPC patients.
• The positive interim results from the ProstACT SELECT study provide further validation of TLX591's potential as a first-in-class rADC therapy and reinforce the company's continued innovation in prostate cancer treatment.

In summary, the interim data from the ProstACT SELECT study highlights the promising safety, tolerability, and preliminary anti-tumor activity of TLX591, supporting its further development as a potential new treatment option for mCRPC patients.