TLX591-Tx ProstACT SELECT Study Published in Cancers Journal
Rhea-AI Summary
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) reported that results from its Phase 1 ProstACT SELECT study of TLX591-Tx, a PSMA-targeting radio antibody-drug conjugate (rADC) for advanced metastatic castration-resistant prostate cancer (mCRPC), have been published in the peer-reviewed journal Cancers.
The study evaluated use of 68Ga-PSMA-PET imaging (Illuccix) to select patients for TLX591-Tx using a theranostic approach and assessed biodistribution, dosimetry, safety and tolerability. According to Telix, TLX591-Tx showed an intensified dosing schedule, prolonged tumor retention, low salivary gland irradiation, a manageable and predictable safety profile, and indicative efficacy with median radiographic progression-free survival of 8.8 months in evaluable patients, supporting the ongoing Phase 3 ProstACT Global trial.
Positive
- Peer-reviewed Phase 1 publication of ProstACT SELECT data in Cancers journal
- Median rPFS 8.8 months in evaluable advanced mCRPC patients as a secondary outcome
- Manageable and predictable safety profile for TLX591-Tx in combination with standard of care
- Imaging concordance supports 68Ga-PSMA-PET (Illuccix) for selecting TLX591-Tx candidates
- Differentiated pharmacologic profile with prolonged tumor retention and low salivary gland irradiation
- Supports Phase 3 ProstACT Global evaluation of TLX591-Tx in advanced prostate cancer
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 15 | First patients dosed | Positive | -4.1% | First patients dosed in Phase 2 OPTIMAL-e trial for earlier-stage prostate cancer |
| Jul 01 | FDA trial alignment | Positive | +0.3% | FDA alignment supported advancing Part 2 of ProstACT Global Phase 3 trial |
| Jun 22 | Educational webinar | Neutral | +2.1% | Educational webinar covered neuro-oncology portfolio and physician perspectives on therapeutic directions |
| Jun 02 | Theranostics collaboration | Positive | -2.8% | Strategic research collaboration combined Telix imaging products with United Imaging platforms |
| Jun 01 | Phase 3 trial data | Positive | -2.8% | Phase 3 ProstACT Part 1 data presented in ASCO late-breaking oral session |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Historical reactions diverged from positive clinical or partnership announcements in three listed cases; FDA trial alignment was followed by a 0.25% gain.
Key Terms
68ga-psma-pet medical
theranostic medical
radiographic progression-free survival medical
spect medical
mcrpc medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Peer-reviewed publication of ProstACT SELECT1 results confirm the utility of 68Ga (gallium)-PSMA-PET imaging to select patients for TLX591-Tx therapy using a theranostic approach2.
- Consistent with previously reported results3, the publication highlights TLX591-Tx’s clinical differentiation and safety profile.
- TLX591-Tx, Telix’s lead PSMA-targeting rADC therapy candidate, is currently being evaluated in ProstACT Global Phase 3 study4 for advanced metastatic prostate cancer.
MELBOURNE, Australia and INDIANAPOLIS , July 22, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announced publication of results from the ProstACT SELECT study in Cancers, a peer-reviewed journal. The Phase 1 study evaluated TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), Telix’s first-in-class prostate-specific membrane antigen (PSMA) targeting radio antibody-drug conjugate (rADC) therapy candidate. The study’s scientific purpose was to evaluate lesion concordance between 68Ga-PSMA-PET5 and multi-time point SPECT6 imaging for patient selection using a “theranostic” approach.
The publication highlights TLX591-Tx’s differentiated clinical profile, including an intensified dosing schedule, prolonged tumor retention and low exocrine (salivary) gland irradiation. The authors also concluded that in a heterogeneous population representative of a real-world setting, TLX591-Tx therapy in combination with standard of care (SOC) demonstrated a manageable and predictable safety profile, and indicative efficacy with a median radiographic progression-free survival (rPFS) of 8.8 months reported in evaluable patients.
Nat Lenzo, MD, Nuclear Medicine Oncologist and Principal Investigator on the ProstACT SELECT study commented, “A key objective of ProstACT SELECT was to determine whether PSMA-PET imaging could reliably identify patients suitable for TLX591-Tx therapy, and the results clearly support this approach. The results provide compelling evidence that the PSMA-PET imaging agent and TLX591-Tx are targeting the same disease sites, supporting the ongoing ProstACT Global trial for mCRPC7, where there remains significant unmet need for additional treatment options.”
David N. Cade, MD, Group Chief Medical Officer, Telix, said, “The publication of ProstACT SELECT data further strengthens the scientific foundation for Telix’s lead therapeutic candidate, TLX591-Tx. The peer-reviewed results support our patient-selection strategy and demonstrate a differentiated pharmacologic profile characterized by durable tumor targeting, hepatobiliary clearance, and a manageable safety profile. Telix is further evaluating TLX591-Tx in the international multi-center Phase 3 ProstACT Global study, where we aim to meaningfully improve outcomes for patients living with advanced prostate cancer.”
The full paper is available at: https://www.mdpi.com/3989748
About ProstACT SELECT
The purpose of the ProstACT SELECT trial was to evaluate the utility of 68Ga-PSMA-PET imaging (Illuccix) to select patients for TLX591-Tx rADC therapy. The primary objectives were to determine whole body biodistribution and organ radiation dosimetry and assess the safety and tolerability of TLX591-Tx in patients with advanced mCRPC. rPFS was a secondary study objective.
About Telix Pharmaceuticals Limited
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease.
Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA). The Company's late-stage therapeutic pipeline includes three assets in pivotal-stage trials: TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (131I-iodofalan) in recurrent glioblastoma, and TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) in kidney cancer, additionally complemented by a deep pipeline of next generation assets. TLX591-Tx has not received a marketing authorization in any jurisdiction.
Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook.
Telix Contacts
| Investor Relations | Media |
| Annie Kasparian | Eliza Schleifstein |
| Annie.kasparian@telixpharma.com | Eliza@schleifsteinpr.com |
| Charlene Jaw | |
| Charlene.jaw@telixpharma.com | |
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1 ClinicalTrials.gov ID: NCT04786847.
2 Lenzo et al. Cancers. 2026.
3 Telix ASX disclosures October 19, 2023 and May 31, 2024.
4 ClinicalTrials.gov ID: NCT06520345.
5 Imaging of prostate-specific membrane antigen with positron emission tomography.
6 Single-photon emission computed tomography.
7 Metastatic castration-resistant prostate cancer.
