ProstACT Global Phase 3 (Part 1) Selected as Late-Breaking Abstract at ASCO 2026
MELBOURNE, Australia and INDIANAPOLIS, April 22, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today announces that safety and tolerability data from the ProstACT Global Phase 3 study (Part 1) will be presented as a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, IL.
ProstACT Global is an international, multi-center, Phase 3 trial evaluating Telix's lead prostate-specific membrane antigen (PSMA) targeted lutetium radio antibody-drug conjugate (rADC) therapy, TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan), in combination with standard of care (SoC) versus SoC alone. The study is designed to reflect real-world global clinical practice with the aim to support broad geographic adoption in the evolving prostate cancer treatment landscape.
Part 1 of the trial is a safety and dosimetry lead-in, assessing the tolerability, biodistribution, and radiation dose profile of TLX591-Tx when administered in combination with SoC in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The selection of this abstract as a late-breaking oral presentation at ASCO underscores the potential clinical significance of the ProstACT Global study and Telix's continued leadership in advancing next-generation radiopharmaceutical therapies for prostate cancer.
Presentation details are as follows:
Presenting Author: Pedro C. Barata, MD, MSc, University Hospitals Seidman Cancer Center, Cleveland, OH.
Abstract Number: LBA5009.
Date, Time and Location: June 1, 2026, 3:12 p.m. – 3:24 p.m. CDT, Arie Crown Theater
Session Type and Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer
Late-breaking abstracts will be made publicly available at 7:00 a.m. CDT (8:00 a.m. EDT) on the day of presentation. Additional information can be found at www.asco.org
About ProstAct Global
ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multi-center trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET1 imaging agent (such as Illuccix®, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix®, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one androgen receptor pathway inhibitor (ARPI).
The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies2, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys3. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs4.
Additional information on the Phase 3 ProstACT Global study can be found at: https://telixpharma.com/prostact/
TLX591-Tx has not received a marketing authorization in any jurisdiction.
About Telix Pharmaceuticals Limited
Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ:TLX).
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
| Telix Investor Relations (Global) Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications [email protected] | Telix Investor Relations (U.S.) Ms. Annie Kasparian Director Investor Relations and Corporate Communications [email protected] | Telix Investor Relations (Australia) Ms. Charlene Jaw Associate Director Investor Relations [email protected] |
| Media Contact Eliza Schleifstein 917.763.8106 (Mobile) [email protected] | ||
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1 Positron emission tomography.
2 Tagawa et al. Curr Oncol Rep. 2021; Steinhelfer et al. J Nucl Med. 2024.
3 Tagawa et al. Cancer. 2019.
4 Pepin et al. Pract Radiat Oncol. 2025.
