In this phase 3 trial, ctDNA-guided adjuvant atezolizumab improved both disease-free survival and overall survival in patients with muscle-invasive bladder cancer compared to placebo. Atezolizumab was associated with higher rates of grade 3 or 4 adverse events compared to placebo, although no new safety signals were identified.
Study
|
Phase 3, double-blind, randomized trial [IMvigor011]. |
| Patients with muscle-invasive bladder cancer and no radiographic evidence of disease post-cystectomy. |
| Atezolizumab (n=167) vs Placebo (n=83) in ctDNA-positive patients.
|
Efficacy
|
Median DFS: 9.9 mos (Atezolizumab) vs 4.8 mos (Placebo) (HR 0.64 [0.47-0.87]) |
| Median OS: 32.8 mos (Atezolizumab) vs 21.1 mos (Placebo) (HR 0.59 [0.39-0.90])
|
Safety
|
Grade >=3 AEs: 28% vs 22% (Atezolizumab vs Placebo) |
| Serious AEs: 27% vs 20% |
| Treatment discontinuation due to AEs: 9% vs 4%
|
N Engl J Med. Published online 2025 Oct 20.
http://doi.org/10.1056/NEJMoa2511885
Reviewed by Ulas D. Bayraktar, MD on Nov 14, 2025
