ESMO 2025 | IMvigor011: ctDNA-guided adjuvant atezolizumab in MIBC

The IMvigor011 study was built on a series of observations that we’ve had in the last decade that the detection of circulating tumor DNA in the blood of patients with muscle-invasive bladder cancer after cystectomy is highly prognostic. So we had several large retrospective studies and even a negative phase 3 trial that had suggested that if you have low or no levels of circulating tumor DNA in your blood after your blood has been drawn, that actually you may be functionally cured of your disease and not have disease recurrences or other events. Whereas those patients that had detectable circulating tumor DNA, maybe those were the ones that needed treatment intensification or definitely adjuvant treatment. However, we’d had no level one evidence to support those observations. So Invigor011 tests that hypothesis and it’s actually, to my knowledge, the first level one evidence that tells you that you can intervene on the basis of a ctDNA positive test in bladder cancer. So that’s a really cool finding. So it’s really split into two parts. The trial took high-risk muscle-invasive bladder cancer after cystectomy, somewhere between six and 24 weeks after cystectomy. And those patients had regular blood tests to look for the presence of ctDNA. If those patients had no evidence for ctDNA throughout the monitoring period they went on to surveillance and the outcomes of those patients were actually really good. So after one year 95% of those patients have not had a disease recurrence. So this tells us that perhaps these patients could actually be managed without adjuvant treatment and most of them may not need further therapy. Of course, it doesn’t technically tell us that it’s safe to de-escalate in this population. That would need a randomized component there, and the modern trial is addressing that. On the other side, those patients with ctDNA, they were randomized two to one to atezolizumab, which is an immune checkpoint inhibitor, versus placebo. And what the trial showed is that those patients that were randomized to atezolizumab, which is an immune checkpoint inhibitor versus placebo. And what the trial showed is that those patients that were randomized to atezolizumab had a significantly better disease-free survival and overall survival compared to placebo. So it’s telling us that when we detect molecular evidence of disease in the blood, that’s a finding we can intervene on and patients benefit more if they receive treatment versus not.

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