Clinical TrialApr 29, 2026, 05:02 PM
TLX TLX597-Tx Phase 2 OPTIMAL-PSMA Trial Shows Favorable Dosimetry
AI Summary
Telix Pharmaceuticals announced positive initial dosimetry results from the randomized Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration-resistant prostate cancer (mCRPC). The findings, presented at IPCS 2026, showed significantly reduced radiation exposure to healthy organs like salivary glands and kidneys, suggesting lower incidence of side effects and potential for dose intensification. These encouraging results support further evaluation of TLX597-Tx in earlier-stage disease, leading to the initiation of the Phase 2 OPTIMAL-E study in androgen pathway-sensitive prostate cancer (mHSPC).
Key Highlights
- TLX597-Tx Phase 2 OPTIMAL-PSMA trial showed favorable dosimetry results.
- Initial dosimetry data demonstrated low salivary gland and kidney uptake.
- Findings support potential for dose intensification and improved quality-of-life.
- OPTIMAL-PSMA is evaluating an intensified dosing regimen (8.5 GBq/cycle) in 120 men.
- Telix is initiating OPTIMAL-E, a Phase 2 study in earlier-stage mHSPC.
- TLX597-Tx is being developed alongside TLX591-Tx, Telix's lead Phase 3 candidate.
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