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In contrast with other strategies, immunotherapy is a treatment aimed at empowering the patient’s immune system in order to increase immunity and the response against cancer. Recently, a new class of drugs, immune checkpoint inhibitors, has shown potential in increasing treatment chances for patients with bladder cancers, improving their survival. However, predicting the response to immune checkpoint inhibition is important, since only a group of patients develop a good response. Biomarkers to predict the response to checkpoint inhibition must identify tumors’ and patients’ specific profiles. This study reviews the current knowledge on this most relevant clinical topic, focusing on bladder cancer, going from basic science to ongoing clinical trials and available clinical evidence. Finally, a critical analysis of published data is provided, and an original panel of biomarkers, able to select the right patients for treatments, based on patient-specific immune profiling, is proposed.

In contrast with other strategies, immunotherapy is the only treatment aimed at empowering the immune system to increase the response against tumor growth. Immunotherapy has a role in the treatment of bladder cancer (BC) due to these tumors’ high tumor mutational burden (TMB) and mostly prominent immune infiltrate. The therapy or combination has to be adjusted to the tumor’s immunobiology. Recently, a new class of immunotherapeutic agents, immune checkpoint inhibitors (ICI), has shown potential in increasing treatment chances for patients with genitourinary cancers, improving their oncological outcomes …