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MELBOURNE, Australia, April 30, 2023 /PRNewswire/ — Telix Pharmaceuticals Limited TLX Telix, the Company) 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…
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