(UroToday.com) The NIVOREN GETUG AFU 26 study is a French multicenter prospective study to evaluate the safety and efficacy of nivolumab in a broad “real world setting” in metastatic renal cell carcinoma (mRCC) after failure of 1 or 2 tyrosine kinase inhibitors. Initial results for this trial were presented at the 2019 GU ASCO annual meeting. Regarding the safety data, 129 patients (17.9%) had at least one grade ≥ 3 treatment-related adverse event, including asthenia (3.5%), metabolic disorders (2.1%), gastrointestinal disorders (2 .2%), musculoskeletal (1.7%), renal disorders (1.4%), hematologic (1.3%). There six treatment-related mortalities. Median progression-free survival was 3.2 months (95%CI 2.9-4.6) and the 12-month OS rate was 69% (95%CI 66-73). At the 2021 GU ASCO annual meeting, Dr. Loic Mourey and colleagues presented results of a subgroup analysis specifically assessing safety and efficacy in older patients.

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