Bladder cancer guideline update includes Signatera™-guided care
Learn MoreBladder cancer guideline update includes Signatera™-guided care Learn More
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.
WEBINAR
Navigating MIBC management: Integrating ctDNA into clinical practice
Monday, July 20th
5:00 - 5:45 PM ET
45 minute webinar
Upcoming Webinar
Join Michael Adashek, DO, medical oncologist, hematologist, and Director of GU Medical Oncology at Chesapeake Urology, for a live, case-based webinar designed for urologists.
This session will explore how ctDNA testing may provide additional insight across key MIBC decision points, including:
- After TURBT and before cystectomy
- During neoadjuvant therapy
- After cystectomy and throughout surveillance
Dr. Adashek will review practical patient cases and discuss relevant clinical data, including IMvigor011 and NIAGARA, to help illustrate how ctDNA may support multidisciplinary MIBC management.
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.