TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) - (OPTIMAL-e)

July 16, 2026: Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) and St Vincent’s Hospital (Sydney) announced first patients dosed with TLX597-Tx (lutetium-177 Lu-DOTA-HYNIC-panPSMA) in OPTIMAL-e, a Phase 2 single-arm, open-label study in metastatic hormone-sensitive prostate cancer (mHSPC). OPTIMAL-e is evaluating adaptive-dosed TLX597-Tx in combination with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI), with the primary focus on PSA response rate and additional assessment of depth/durability of PSA response and safety of dose intensification. Adaptive dosing uses PSMA-PET imaging and PSA to continue treatment when the PSMA target persists and pause/restart based on tumor burden reduction and confirmed PSA rise. The program builds on the OPTIMAL-PSMA study, which has recently completed enrollment. Telix noted TLX597-Tx has not received marketing authorization in any jurisdiction.

Separately, Telix stated TLX591-Tx (lutetium-177 rosopatamab tetraxetan) is in the Phase 3 ProstACT Global trial in metastatic castration-resistant prostate cancer (mCRPC), with active dosing in jurisdictions with regulatory approval.