ZIRCON Phase III Renal Cancer Study to be Presented at ASCO GU along with Theranostic Pipeline Advances

• Compete data from global Phase III ZIRCON study of Telix's investigational imaging agent TLX250-CDx in clear cell renal cell carcinoma (ccRCC) will be presented at American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (ASCO GU) in February 2023
• Telix pipeline featured across seven presentations including first reveal of the STARBURST study exploring utility of TLX250-CDx in tumour types beyond ccRCC; TLX250 therapy in ccRCC; and real-world experience using 68Ga-PSMA-11 with the uExplorer total-body PET/CT scanner

MELBOURNE, Australia and INDIANAPOLIS, Dec. 21, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the completed pivotal Phase III ZIRCON study (ClinicalTrials.gov Identifier: NCT03849118) of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) has been selected for oral presentation at the upcoming 2023 ASCO GU Symposium to be held in San Francisco, CA, from February 16-18 2023.

ASCO GU, the leading specialised event for GU cancer care worldwide, will be the forum at which the Company will present the complete results of the ZIRCON trial in detail, including all trial primary and secondary end-points as well as specific grading criteria related to lesion size and detection.

In addition, six presentations on Telix's carbonic anhydrase IX (CAIX)- and prostate specific membrane antigen (PSMA)-targeting theranostic candidates will be featured in the program. Presentations will report on advancements in positron emission tomography (PET) imaging of prostate cancer with ⁶⁸Ga PSMA-11; the potential utility of TLX250-CDx in tumour types beyond ccRCC; and the STARLITE Phase II studies, which are assessing the efficacy of TLX250 (¹⁷⁷Lu-DOTA-girentuximab) targeted radiation in combination with immunotherapy for ccRCC.

Dr Colin Hayward, Telix Chief Medical Officer, said, "Telix's vision is to drive innovation in urologic oncology across the patient continuum, harnessing the power of targeted radiation from imaging, to surgery and therapy. We are therefore excited to be so well represented at ASCO-GU, the leading specialised event for GU cancer care worldwide. A highlight will be the first presentation of finalised, detailed clinical data from the Phase III ZIRCON study of TLX250-CDx, which reported highly positive topline data in November.^[1] The congress program also includes updates on Telix-sponsored and investigator-initiated diagnostic and therapeutic studies and research collaborations across prostate and kidney cancer, and other tumour types. We look forward to seeing you at our booth."

ASCO GU presentation materials will published to the ASX and an investor conference call and webcast will be held following presentation of results with joining details to be announced closer to the event.

ASCO GU presentation details are as follows:

Session: Oral Abstract Session C: Renal and Rare Tumors
Title: Results from phase 3 study of 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma (ZIRCON)
Date and Time: 18-Feb-2023, 2:00 PM-3:30 PM
Presenter: Brian Shuch (UCLA)
Abstract ID: LBA602

Poster Session B: Prostate Cancer and Urothelial Carcinoma
Date and Time: 17-Feb-2023, 12:30 PM-2:00 PM & 5:15 PM-6:15 PM

• Title: "⁶⁸Ga-PSMA-11 patients with newly diagnosed and recurrent prostate cancer (Firefly Study) - Preliminary Results."
  Presenter: Hawkins, Charlotte (Telix); senior author: Oliver Sartor (Tulane Cancer Center)
  Abstract ID: 54
  ClinicalTrials.gov Identifier: NCT04854369

• Title: "Ga-68 PSMA-11 (Illuccix) impacting prostate cancer management in a real-world setting: a pilot experience using the total-body PET/CT scanner (uExplorer)."
  Presenter: Hashad Kulkarni (BAMF Health)
  Abstract ID: 62
  
  
• Title: "Special access use of ⁶⁸Ga-PSMA-11 in Canada: real world experience."
  Presenter: Philip Cohen (Initio Medical)
  Abstract ID: 102

Trials in Progress Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers
Date and Time: 18-Feb-23, 07:00 AM-08:00 AM & 12:30 PM-2:00 PM

• Title: "⁸⁹Zr-DFO-girentuximab for PET imaging of solid tumors likely to express high levels of carbonic anhydrase IX" (STARBURST study)"
  Presenter: Andrei Iagaru (Stanford University)
  Abstract ID: TPS738
  ClinicalTrials.gov Identifier: NCT05563272

• Title: "Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naïve patients with advanced clear cell RCC" (STARLITE 1 study)
  Presenter: Elshad Hasanov (MD Anderson Cancer Center)
  Abstract ID: TPS749

• Title: "Phase 2 Study of Nivolumab plus 177Lutetium-labeled Anti–Carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (177Lu-girentuximab) in Patients (pts) with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)" (STARLITE 2 study)
  Presenter: Darren Feldman (Memorial Sloan Kettering Cancer Center)
  Abstract ID: TPS752
  ClinicalTrials.gov Identifier: NCT05239533

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

TLX250-CDx (⁸⁹Zr-DFO-girentuximab) has not received a marketing authorisation in any jurisdiction. Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),^[2] and by the Australian Therapeutic Goods Administration (TGA),^[3] and by Health Canada.^[4]

[1] ASX disclosure 7 November 2022.
[2] ASX disclosure 20 December 2021.
[3] ASX disclosure 2 November 2021.
[4] ASX disclosure 14 October 2022.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer. 

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