Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:TLX, "Telix") today announces the publication of a new independent analysis of Phase 3 ZIRCON trial data in European Urology1, demonstrating that TLX250-Px (Zircaix®2, 89Zr-girentuximab) PET/CT3 imaging may be highly predictive of renal malignancy across all subtypes, not limited to clear cell renal cell carcinoma (ccRCC).

Recognizing that carbonic anhydrase IX (CAIX) expression is also observed in other renal cancer subtypes4, this subsequent analysis conducted by international investigators who participated in ZIRCON Phase 3 trial5, evaluated centrally reviewed imaging and pathology data to explore whether tracer uptake in renal masses correlated with malignancy beyond ccRCC.

The analysis demonstrated that positive PET findings were highly predictive of malignancy overall, including in non-clear cell renal cell carcinoma (nccRCC), with a reported positive predictive value (PPV) of 98% (95% CI, 96–99), sensitivity of 82% (95% CI, 82–90), and specificity of 87% (95% CI, 81–93). These exploratory scientific findings suggest TLX250-Px has applications beyond the detection of ccRCC in primary renal masses and may have implications to management of nccRCC.