Three-year follow-up of adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma in CheckMate 274

CheckMate 274 is a phase 3 trial of adjuvant nivolumab versus placebo for muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence after radical resection. Results of the study with 36.1 months median follow-up have now been published. Disease-free survival benefit with nivolumab over placebo was seen in the ITT population (HR 0.71; 95% CI 0.58-0.86) and in the PD-L1 ≥ 1% population (0.52; 0.37-0.72). Also overall survival benefit with nivolumab over placebo was seen in the ITT population (HR 0.76; 95% CI 0.61-0.96) and the PD-L1 ≥ 1% population (0.56; 0.36-0.86). Continuous benefit in nonurothelial tract recurrence-free survival and distant metastasis-free survival was also observed in both patient populations. Exploratory analysis of patients with muscle-invasive bladder cancer also foundt benefit with nivolumab. No new safety signals were reported. The authors conclude that these results further support adjuvant nivolumab for high-risk MIUC after radical resection.