Beyond the Biomarker: Reframing Immunotherapy Selection as a Clinical Decision Problem in Genitourinary Cancers

Immune checkpoint inhibitors have transformed the management of several genitourinary malignancies, but they have not solved the problem of patient selection. Across urothelial carcinoma, renal cell carcinoma, and prostate cancer, immunotherapy can produce durable benefit in selected patients; however, many patients do not respond, receive treatment in settings where benefit is modest, or experience clinically meaningful toxicity without sufficient gain. The central challenge is therefore not simply to identify a positive biomarker, but to determine whether that biomarker can improve a specific treatment decision for a specific patient in a specific clinical context.