Telix Highlights Low Organ Uptake Enabling 8.5 GBq TLX597-Tx Dose Intensification
Initial dosimetry from the Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in 120 mCRPC patients shows low salivary gland and kidney uptake, enabling potential dose intensification to 8.5 GBq on days 1, 3 and 15. These results support initiating the OPTIMAL-E study in earlier-stage mHSPC to refine therapeutic windows and improve quality-of-life.
1. Dosimetry Results from OPTIMAL-PSMA Trial
Initial Phase 2 dosimetry data in 120 men with metastatic castration-resistant prostate cancer demonstrated low radiation exposure to salivary glands and kidneys compared with existing PSMA RLTs, suggesting a wider therapeutic window for TLX597-Tx.
2. OPTIMAL-PSMA Trial Design and Regimen
This open-label, randomized study employed a 2:1 randomization to compare an intensified dosing schedule—8.5 GBq administered on days 1, 3 and 15 followed by three additional 10-weekly cycles—against a standard dose regimen, assessing safety, dosimetry and efficacy endpoints.
3. Next Steps and Pipeline Positioning
Buoyed by favorable organ-sparing data, Telix is launching OPTIMAL-E, a Phase 2 trial in metastatic hormone-sensitive prostate cancer, while continuing to advance TLX591-Tx in a Phase 3 mCRPC program to offer tailored PSMA-targeted radiopharmaceutical options across disease stages.