Girentuximab

Dr. Bernadett E. Szabados discussed circulating vs. tissue-based biomarkers for urothelial and renal cell carcinomas at the 2024 ESMO meeting, highlighting established (FGFR3, PD-L1, ctDNA, HER2) and experimental biomarkers. FGFR3 expression varies by tumor stage, with erdafitinib targeting FGFR-positive metastatic urothelial carcinoma. PD-L1 testing shows mixed outcomes, while ctDNA correlates with disease burden and prognosis. For renal cell carcinoma, experimental biomarkers like PD-L1 and RNA-based molecular subtypes are under evaluation. Circulating biomarkers, particularly KIM-1, show promise in RCC.

The phase 3 ZIRCON trial reported TLX250-CDx's high accuracy in detecting ccRCC, with sensitivity of 85.5% and specificity of 87%. Telix must resubmit the BLA for TLX250-CDx after FDA concerns over sterility assurance. TLX250-CDx aims to be the first targeted PET agent for kidney cancer in the U.S.