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ESMO 2021 | Biomarker development in RCC and UC

Laurence Albiges, MD, PhD, Gustave Roussy Institute, Villejuif, France, discusses the development of biomarkers for genitourinary malignancies, including renal cell carcinoma (RCC) and urothelial carcinoma (UC). Several prospective trials have allowed identifying patient groups with RCC that respond distinctly to different therapy types in the first-line setting. The BIONIKK Phase II biomarker-driven trial (NCT02960906) used patients’ tumor molecular characteristics to decide whether patients with metastatic clear cell RCC (mccRCC) should receive nivolumab monotherapy, nivolumab plus ipilimumab combination therapy or a tyrosine kinase inhibitor. In addition, the Phase III SAVOIR trial (NCT03091192) compared savolitinib monotherapy versus sunitinib monotherapy in patients with MET-driven unresectable and locally advanced, or metastatic papillary renal cell carcinoma (PRCC). Nevertheless, conducting biomarker-based studies remains a challenge in rare tumors and there are still no biomarkers that have entered clinical practice for patients with RCC. In UC, the identification of FGFR gene mutations have led to the development of erdafitinib, a FGFR inhibitor, which is currently being investigated in NORSE, a Phase Ib/II biomarker-driven clinical trial (NCT03473743). There have been a lot of efforts to demonstrate that biomarker-based strategies are more efficient than all-comers strategies. Nevertheless, further research is required both in RCC and UCC to build prospective clinical trials that will eventually help personalizing treatments. This interview took place at the European Society for Medical Oncology (ESMO) 2021 congress.

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