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

Melbourne (Australia) | 22 December 2022

Telix 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