Clinical TrialJun 1, 2026, 05:00 PM
Telix TLX591-Tx Phase 3 Study Shows Acceptable Safety Profile
AI Summary
Telix Pharmaceuticals announced positive Part 1 safety, dosimetry, and pharmacokinetics data from its ProstACT Global Phase 3 Study of TLX591-Tx for metastatic castration-resistant prostate cancer (mCRPC). The data, presented at ASCO 2026, demonstrated an acceptable safety and tolerability profile with no new safety signals when combined with standard-of-care therapies. These findings support the feasibility of TLX591-Tx, and Part 2 of the study is actively dosing patients in several jurisdictions, with engagement underway for U.S. FDA approval.
Key Highlights
- TLX591-Tx demonstrated acceptable safety and tolerability in Part 1 of the ProstACT Global Phase 3 study.
- No new safety signals were identified across all standard-of-care combination cohorts.
- All 36 patients in Part 1 received both doses of TLX591-Tx per protocol.
- Grade 3 hematologic events included thrombocytopenia (14%) and neutropenia (22%).
- Grade 4 hematologic events included thrombocytopenia (31%) and neutropenia (25%), consistent with expectations.
- Radiation exposure to key organs was well below established safety limits.
- Part 2 of the study is actively dosing patients in multiple international jurisdictions.
- Telix is engaging with the U.S. FDA to progress Part 2 in the U.S.
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