ctDNA-Guided Atezolizumab Extends Survival After Bladder Cancer Surgery in Phase III Trial

Overview

• In ctDNA-positive patients, atezolizumab cut the risk of death by 41% and of recurrence or death by 36% versus placebo.
• Median disease-free survival reached 9.9 months with atezolizumab versus 4.8 with placebo, and median overall survival was 32.8 versus 21.1 months.
• The global, double-blind IMvigor011 trial screened 761 post-cystectomy patients with Natera’s Signatera test and randomized 250 ctDNA-positive patients 2:1 to treatment or placebo.
• Patients who stayed ctDNA-negative after surgery received no adjuvant therapy and showed low recurrence, with 89% disease-free and over 90% overall survival at 21.8 months’ follow-up.
• Findings were presented at ESMO 2025 and published in NEJM, with no new safety signals reported and plans to discuss potential companion-diagnostic use with health authorities.