Signatera Shows 73-77% ctDNA Clearance and 91% Two-Year Bladder-Intact Survival
At ASCO GU, Natera reported 73-77% ctDNA clearance in MIBC with Signatera-negative patients achieving 88.6% baseline and 91% post-neoadjuvant two-year bladder-intact event-free survival. NIAGARA findings show combined utDNA and ctDNA status identifies patients with highest 24-month event-free survival, mapping utDNA positivity to non-invasive and ctDNA to invasive residual disease.
1. ASCO GU Data Presentation
Natera unveiled new molecular residual disease data at the Genitourinary Cancers Symposium, featuring four oral presentations across muscle-invasive bladder cancer studies. The company highlighted Signatera’s role in identifying patients for adjuvant immunotherapy, response-adaptive bladder preservation, and refined MRD detection using plasma ctDNA and urinary tumor DNA.
2. INDIBLADE and RETAIN Trials Show Signatera Utility
Phase 2 INDIBLADE and RETAIN trials demonstrated consistent ctDNA clearance rates of 73-77% following neoadjuvant regimens. Signatera-negative status at baseline and after therapy correlated with 88.6% and 91% estimated two-year bladder-intact event-free survival, supporting bladder-sparing strategies guided by ctDNA results.
3. NIAGARA Trial Highlights Combined utDNA and ctDNA Assessment
The randomized phase 3 NIAGARA study introduced the first clinical correlation of urinary tumor DNA data, showing combined utDNA and ctDNA status before cystectomy identified the subgroup with the highest 24-month event-free survival. utDNA positivity linked to residual non-invasive disease, while ctDNA positivity associated with invasive residual disease.