GU Cancers 2026 | Biomarkers and imaging in bladder-sparing MIBC in the Indi-Blade trial
The Indi-Blade trial (NCT05200988) assessed induction ipilimumab plus nivolumab followed by chemoradiotherapy as a bladder-sparing strategy for muscle-invasive bladder cancer (MIBC). Jan-Jaap Mellema, MD, Netherlands Cancer Institute, Amsterdam, The Netherlands, discusses the potential clinical significance of the trial, particularly with the emergence of enfortumab vedotin, and the role of biomarkers such as plasma ctDNA and urinary tumor DNA in response evaluation and detection of local recurrence. New innovations in imaging, including multi-parametric MRIs, are additionally emerging to predict pathological complete response. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.
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Transcript
So we believe that the approach of the Indie Blade trial in itself, and given our results, could actually justify further clinical development of a randomized clinical trial. But with the emergence of Enfortumab Vedotin, especially now with the recent results in the perioperative setting, we feel that we can use this very potent systemic therapy before consolidative treatment in the same way that we now have approached bladder-sparing treatment in the IndieBlade trial...
So we believe that the approach of the Indie Blade trial in itself, and given our results, could actually justify further clinical development of a randomized clinical trial. But with the emergence of Enfortumab Vedotin, especially now with the recent results in the perioperative setting, we feel that we can use this very potent systemic therapy before consolidative treatment in the same way that we now have approached bladder-sparing treatment in the IndieBlade trial. So very potent systemic induction followed by response evaluation, which you then might be able to discern which patients would be better off with cystectomy, bladder-sparing, chemoradiotherapy, or maybe even active surveillance. And in regards to, so we would imagine that future studies might be able to randomize, for example, between active surveillance or chemoradiotherapy if patients have a clinical complete response and either might be better off with cystectomy; future studies would then be able to also maybe discern what the added value of adjuvant therapy might be in this setting, which is very interesting and then quite a hot debate at the moment and how far we need to go in that sense. And we see that plasma ctDNA really will have a place in that setting. If you have a response evaluation like that, clinical circulating tumor DNA is highly associated with survival and also associated with pathological complete response in some sense. But we saw from the results from the NERO, for example, that urinary tumor DNA might be a very, very useful addition in that, where local recurrence or local residual disease is much better detected using urinary tumor DNA instead of ctDNA. In addition to that, so the biomarkers, we can also look at new innovations in imaging with, for example, multi-parametric MRIs, for which we are ourselves now currently using surgical studies to train AI models to predict pathological complete response. And we hope to validate that set in the INIBLADE trial to give an idea of what this predictive value might be in a bladder preservation setting.
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