EAU 2023 | ZIRCO: 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma

Carmen Mir Maresma, MD, PhD, FEBU, Fundacion Instituto Valenciano Oncologia, Valencia, Spain, provides an overview of the Phase III ZIRCON (NCT03849118) study of 89Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma (ccRCC). Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), an enzyme highly expressed ccRCC. Radiolabeled 89Zr-DFO-girentuximab (TLX250-CDx) is highly specific for CAIX. The ZIRCON study evaluated the performance of TLX250-CDx PET/CT for detection of ccRCC in adult patients with indeterminate renal masses (IDRM). The coprimary objectives were to evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to noninvasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth. Key secondary objectives included sensitivity and specificity of TLX250-CDx PET/CT imaging in the subgroup of patients with IDRM ≤ 4 cm (cT1a). Other secondary objectives included positive and negative predictive values, safety, and tolerability. 300 patients received TLX250-CDx. Of 288 patients with central histopathology of surgical samples, 193 (67%) had ccRCC, and 179 (62%) had CT1a; Of 284 evaluable patients included in primary analysis, the average across all 3 readers for sensitivity and specificity was 86% and 87% respectively for coprimary endpoints; and 85% and 90% respectively for key secondary endpoints. This interview took place at the EAU congress in Milan, Italy.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.