IMvigor011
After cystectomy for muscle-invasive bladder cancer, does serial ctDNA testing identify patients who benefit from adjuvant atezolizumab?
250 patients with post-cystectomy muscle-invasive bladder cancer and detectable circulating tumour DNA during serial monitoring.
Atezolizumab 1,680 mg IV every 4 weeks, for up to 12 cycles or one year.
Placebo among ctDNA-positive patients who were randomized.
Randomized, double-blind, placebo-controlled phase III study.
Key outcomes in ctDNA-positive patients
Median disease-free survival: 9.9 vs 4.8 months; HR 0.64 (95% CI 0.47–0.87), P=0.0047.
Median overall survival: 32.8 vs 21.1 months; HR 0.59 (95% CI 0.39–0.90), P=0.0131.
Values and hazard ratios are from the FDA's trial summary. Bars are illustrative only; they do not represent an absolute treatment effect.
Critical appraisal
The randomized treatment effect applies to the ctDNA-positive population, not to every patient after cystectomy. The strategy depends on serial molecular testing and assay-defined eligibility. Do not extrapolate benefit to ctDNA-negative patients or calculate NNT from median survival or a hazard ratio.
Current-practice context
US FDA approval was granted on 15 May 2026 for post-cystectomy MIBC with ctDNA molecular residual disease detected by an FDA-authorized test. The companion diagnostic was approved at the same time. Local regulatory status and test access should be checked.
Dated context added 14 October 2026. This is not a claim that all subsequent guideline updates have been exhaustively reviewed.