Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma

The role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma after radical surgery is not clear. The multinational phase 3 trial CheckMate 274 compared adjuvant nivolumab versus placebo after radical surgery. In the ITT population the disease-free survival rate at six months was 74.9% with nivolumab versus 60.3% with placebo (HR 0.70; p<0.001). Among patients with a PD-L1 expression level of 1% or more, the DFS rate was 74.5% with nivolumab versus 55.7% with placebo (HR 0.55; p<0.001). The percentage of patients free from recurrence outside the urothelial tract at six months was 77.0% with nivolumab versus 62.7% with placebo (HR 0.72; 95% CI 0.59-0.89) in the ITT population and 75.3% with nivolumab versus 56.7% with placebo (HR 0.55; 95% CI 0.39-0.79) among patients with a PD-L1 expression level of 1% or more.