ZIRCON Phase III Kidney Cancer Imaging Study Presented at AUA: New Data Confirms Efficacy in Masses 2cm or Smaller

Melbourne (Australia) | 1 May 2023

Telix today announces additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118).

The results were featured in a late-breaking oral presentation delivered on Sunday, 30 April 2023 (CST) by Associate Professor Brian Shuch, MD, Director, Kidney Cancer Program, UCLA Institute of Urologic Oncology (Los Angeles, California) and a principal investigator in the Phase III ZIRCON study, at the American Urological Association’s (AUA) Annual Meeting in Chicago.

New data presented demonstrates the high value of TLX250-CDx PET/CT imaging in detecting ccRCC, with secondary analysis confirming utility and effectiveness in very small renal masses, which are prevalent and present a significant diagnostic challenge.

In very small renal lesions (≤2cm, a secondary endpoint), sensitivity was 84% for all three readers, with specificity 92.3% to 100%. This reinforces the accuracy of this investigational diagnostic imaging agent across all analyses, with previously presented data showing an overall sensitivity and specificity of 86% and 87%, respectively.[1],[2]

Dr Colin Hayward, Chief Medical Officer at Telix stated, “The excellent sensitivity and specificity for small lesions considerably expands the clinical utility and potentially the commercial opportunity for TLX250-CDx. We expect that the ability to diagnose even very small lesions as ccRCC will be an important factor in driving market adoption, subject to product approval.”

Associate Professor Brian Shuch, MD commented, “It is a great pleasure to be showcasing new data from Telix’s Phase III ZIRCON study at AUA, the largest gathering of urologists in the world. We now have analyses on the outcome for very small renal masses, where the data set still shows outstanding sensitivity and specificity, far exceeding confirmatory trial success targets. This data is meaningful for surgeons to help them improve management by aiding risk stratification, selecting appropriate patients for treatment or in those where further imaging/biopsy could be indicated.”

Telix is in the process of implementing an expanded access program in the United States and establishing named patient programs for TLX250-CDx in Europe.

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[1] Top line data released to ASX on 7 November 2022.

[2] Telix media release 20 February 2023.