Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) announced that a new analysis published in European Urology demonstrates its experimental imaging drug TLX250-Px may detect kidney cancers beyond clear cell renal cell carcinoma.

The analysis of Phase 3 ZIRCON trial data showed positive PET findings were highly predictive of malignancy overall, including in non-clear cell renal cell carcinoma, with a positive predictive value of 98%, sensitivity of 82%, and specificity of 87%.

The study evaluated centrally reviewed imaging and pathology data to explore whether tracer uptake in renal masses correlated with malignancy beyond clear cell renal cell carcinoma. International investigators who participated in the ZIRCON Phase 3 trial conducted the subsequent analysis.

"This analysis shows that when TLX250-Px PET/CT is positive, it is highly predictive of renal malignancy, including beyond ccRCC," said Dr. Aboubacar Kaba, urologist at the University of California, Los Angeles and corresponding author.

The findings represent exploratory analyses and were not the basis of Telix's Biologics License Application submission for TLX250-Px, which focuses exclusively on detection of clear cell renal cell carcinoma in primary renal masses.

TLX250-Px works by binding to carbonic anhydrase IX, a target protein expressed on more than 95% of clear cell renal cell carcinoma cells. The drug has not received marketing authorization in any jurisdiction.

The original ZIRCON trial evaluated TLX250-Px in 300 patients and met all primary and secondary endpoints, showing 86% sensitivity and 87% specificity for clear cell renal cell carcinoma detection.