Multinational phase 3 trial of ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer

Patients with muscle-invase bladder cancer (MIBC) have varied outcomes after cystectomy. ctDNA-based detection of molecular residual disease may identify patients at high risk for recurrence after cystectomy who can benefit from adjuvant immunotherapy, thus sparing patients at lower risk from unnecessary treatment burden. The multinational phase 3 IMvigor011 trial used serial ctDNA testing to monitor (for up to 1 year) patients with MIBC and no radiographic evidence of disease after surgery. Patients who tested ctDNA-positive during surveillance were randomly assigned to atezolizumab or placebo every 4 weeks for up to 1 year. Among these patients, atezolizumab led tot longer disease-free survival (median 9.9 versus 4.8 months) as well as longer overall survival (median 32.8 versus 21.2 months) than placebo. The authors conclude that among patients with MIBC, ctDNA-guided adjuvant atezolizumab led to significantly longer DFS and OS than placebo.