Telix Reports Positive Trial Results for Investigational PET/CT Agent in Renal Mass Diagnosis

Telix Pharmaceuticals has announced encouraging new data for TLX250-CDx (Zircaix), its investigational PET/CT imaging agent designed to help characterize indeterminate renal masses and diagnose clear cell renal cell carcinoma (ccRCC). The findings suggest the agent could substantially improve clinical decision-making compared with standard imaging.

Using imaging data from the Phase 3 ZIRCON trial, the post-hoc analysis found that nearly half of the 294 patients evaluated (48.6%) would have experienced a change in management had TLX250-CDx been used instead of standard contrast-enhanced imaging. More than 20% of these patients could have potentially avoided an invasive biopsy.

Overall, 37.4% of patients would have undergone a major management change, including treatment escalation or de-escalation. Notably, 18 patients originally slated for active surveillance would have been shifted to immediate treatment. The findings will be presented at the 26th Annual Meeting of the Society of Urologic Oncology in Phoenix.

According to investigators, TLX250-CDx offers clearer spatial localization of ccRCC within the kidney, supporting more precise treatment planning. “These are compelling results, which demonstrate that TLX250-CDx PET/CT has significant potential to impact clinical decision-making in the diagnostic work-up of patients presenting with small indeterminate renal masses and give physicians greater confidence in clinical planning,” said Karolien Goffin, MD, principal investigator for the ZIRCON program.

David N. Cade, MD, Telix’s group chief medical officer, said the findings strengthen the case for the agent’s clinical value. “This analysis is another demonstration of the potential clinical usefulness of TLX250-CDx, Telix’s breakthrough precision diagnostic candidate, which has recently been added to international guidelines for renal imaging,” he noted. “These results indicate that TLX250-CDx may deliver on an unmet need for better noninvasive diagnostic work-up for ccRCC that can improve risk stratification and minimize overtreatment and undertreatment.”

If approved, the agent could offer clinicians a more accurate, noninvasive tool for diagnosing and managing renal masses, potentially reducing unnecessary procedures and improving treatment selection for patients with suspected ccRCC.