Telix’s Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology

MELBOURNE, Australia, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that primary results from its Phase III ZIRCON¹ trial have been published in The Lancet Oncology, reporting that Telix’s first-in-class investigational PET² agent, TLX250-CDx (Zircaix³, ⁸⁹Zr-girentuximab), is highly accurate in detecting and characterizing clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs).

In this peer-reviewed manuscript, Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues report results from this prospective, open-label, multicentre, Phase III trial in which 300 patients with an IRM ≤7cm (cT1) received TLX250-CDx. Authors conclude that TLX250-CDx “has a favorable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterization of ccRCC, which has the potential to be practice changing.”

Authors explain that small masses in the kidney are increasingly being detected incidentally when patients undergo abdominal imaging, often for other health conditions, contributing to “an era of gross overtreatment”. Diagnosis and treatment are limited by current imaging techniques, and renal mass biopsy is invasive, which can often lead to complications. Up to 30% of patients undergo unnecessary surgery, removing masses that are later determined to be benign⁴. If confirmed, however, ccRCC is the most common and aggressive form of kidney cancer, and delays in diagnosis can significantly reduce survival rates.

Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology, and a ZIRCON principal investigator, said, “Until now, assessing whether renal masses are cancerous has been difficult and often involves invasive surgery or percutaneous biopsy. This is because standard imaging technology – either a CT or MRI scan – cannot reliably differentiate between benign or malignant renal lesions or provide information about disease biology.

“The challenges and uncertainty in diagnosing ccRCC underscore a critical unmet need for a new, non-invasive technique that accurately detects and differentiates ccRCC from other renal masses in patients, to inform clinical decision making. The ZIRCON trial has shown that TLX250-CDx is a breakthrough technology that can address this need.”