Signatera™ for Muscle-Invasive Bladder Cancer (MIBC)
Personalized ctDNA testing to risk-stratify patients, inform treatment decisions, and detect molecular recurrence earlier than standard tools.
First and only randomized phase 3 trial supporting ctDNA-guided treatment in MIBC
IMvigor011 demonstrated improved outcomes with a ctDNA-guided treatment approach in muscle-invasive bladder cancer.
ctDNA+ patients
benefit from adjuvant immunotherapy
36%
lower risk of recurrence or death.1
ctDNA– patients
may avoid unnecessary treatment
95%
disease-free at 1 year with observation alone.2
Detect recurrence
earlier than imaging
96
days earlier detection of relapse.3
IMvigor011 trial results
- ctDNA-positive patients had improved DFS vs placebo.
- Median DFS: 9.9 vs 4.8 months (HR 0.64).
- Reduced risk of death by 41% (HR 0.59).
Supports ctDNA-guided treatment escalation in high-risk MIBC.
Clinical decision points for Signatera™ across the MIBC continuum
Phase 3 evidence supporting Signatera™ in MIBC
Phase 3 and perioperative studies support the clinical utility of personalized ctDNA testing in MIBC.
IMvigor011
Persistently ctDNA-negative patients demonstrated favorable outcomes with surveillance alone:
- OS: 100% at 12 months; 98% at 18 months¹
- DFS: 92% at 12 months; 88% at 18 months¹
NIAGARA
ctDNA status remained highly prognostic in patients receiving perioperative immunotherapy:
- ctDNA-negative patients had significantly improved outcomes²
- ctDNA negativity after cystectomy was associated with a 91% lower risk of relapse²
- ctDNA clearance during treatment correlated with improved event-free survival²
CheckMate274
ctDNA identified patients most likely to benefit from adjuvant nivolumab:
- Median DFS: 52.1 vs 5.0 months by ctDNA status³
- ctDNA-positive patients derived greater benefit from nivolumab³
Explore real-world cases
Post-Surgical MRD Assessment
Persistent ctDNA positivity after cystectomy identified residual disease and supported initiation of adjuvant nivolumab:
- ctDNA levels decreased after surgery but remained detectable
- ctDNA declined further after adjuvant immunotherapy
Recurrence Monitoring
Serial ctDNA monitoring detected molecular recurrence before radiographic progression:
- Median lead time over imaging: 96 days²
- ctDNA detected recurrence in 13 of 17 patients after cystectomy²
Immunotherapy Response Monitoring
ctDNA dynamics helped clarify treatment response during pembrolizumab therapy:
- Imaging initially suggested progression while ctDNA levels decreased
- Pembrolizumab treatment was continued
- ctDNA clearance preceded radiographic resolution³
Is Signatera™ for MIBC right for your patients?
1Powles T, et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer (IMvigor011). New England Journal of Medicine. 2025.
2Powles T, et al. IMvigor011: Phase 3 study of ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. Presented at ESMO 2025.
3Christensen E, et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. Journal of Clinical Oncology. 2019;37(18):1547–1557.
4Sfakianos JP, et al. Association of tumor-informed circulating tumor DNA detectability before and after radical cystectomy with disease-free survival in patients with bladder cancer. European Urology Oncology. 2025.
5Powles T, et al. Circulating tumor DNA in patients with muscle-invasive bladder cancer receiving perioperative durvalumab (NIAGARA). Presented at ASCO 2025.