Loading
Patients whose blood turned positive for tumour DNA after cystectomy lived longer with atezolizumab than placebo; patients who stayed ctDNA-negative did well without any treatment. It is the first ctDNA-guided adjuvant trial to improve survival.
IMvigor011 enrolled patients with muscle-invasive bladder cancer after radical cystectomy into ctDNA surveillance with a tumour-informed assay (Signatera). Those who became ctDNA-positive within a year were randomised 2:1 to atezolizumab or placebo; those who remained negative were followed without treatment.
In the ctDNA-positive randomised population, atezolizumab improved disease-free survival (HR 0.64) and overall survival (HR 0.59) versus placebo. Patients who never became ctDNA-positive had very low recurrence rates, supporting the safety of withholding adjuvant therapy from them. The design was built on the exploratory IMvigor010 ctDNA analysis (Powles, Nature 2021), which had shown benefit confined to ctDNA-positive patients.
Regulatory approval in 2026 made this the first indication defined by a ctDNA result.
After bladder removal, a blood test can now tell who needs immunotherapy and who can safely be spared it. This is the model for MRD-guided adjuvant therapy across cancers: treat the blood-positive, watch the blood-negative.
Shares ctDNA MRD → adjuvant therapy decision, IMvigor011, Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares IMvigor011, Signatera, Dormant cells and minimal residual disease, Minimal / molecular residual disease (MRD).
Shares ctDNA MRD → adjuvant therapy decision, Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment, Dormant cells and minimal residual disease.
Shares ctDNA MRD → adjuvant therapy decision, IMvigor011, Signatera, Dormant cells and minimal residual disease.
Shares Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment, Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative.
Shares Thomas Powles, Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative, PD-L1.
Shares Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment, Dormant cells and minimal residual disease, Neoadjuvant / adjuvant / perioperative.
Shares Dormant cells and minimal residual disease, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA), Biomarkers are not validated or standardised.