I’m Natalia Gandur and I’d like to share with you the key updates in bladder cancer from ESMO 2025, a meeting that clearly marks the beginning of the era of antibody-drug conjugates and biomarker-driven therapy in this tumour.

Let’s start with KEYNOTE-905 presented by Dr Christof Vulsteke during the Presidential Symposium. This trial combined enfortumab vedotin with pembrolizumab in patients with muscle-invasive bladder cancer who were ineligible for cisplatin. The results were remarkable – 57% pathologic complete response compared with only 8% in patients undergoing surgery alone and 60% reduction in the risk of events, together with a 50% reduction in mortality. These findings, it’s important to say, establish a new perioperative standard of care for patients who can not receive platinum-based chemotherapy.

In bladder cancer, in this tumour, the second case study, very important, was RC48-C016 presented by Dr Jun Guo from Peking University Cancer Hospital in China. This trial evaluated the anti-HER2 antibody-drug conjugate disitamab vedotin compared with a PD-1 inhibitor toripalimab in HER2+ metastatic urothelial carcinoma. The results were stunning, really, really, with a PFS of 13.1 versus 6.5 months, overall survival of 31.5 versus 16.9 months and an objective response rate of 76%. This study clearly showed that ADCs plus immunotherapy combine and this combination will guide by biomarkers a highly, highly, effective and may reshape the treatment landscape for this scenario – advanced metastatic bladder cancer.

Another important contribution came from IMvigor011 presented by Thomas Powles which explored the use of circulating tumour DNA to select patients who truly need adjuvant atezolizumab after surgery. Although still preliminary, this work signals the start of personalised adjuvant therapy based on molecular risk.

Finally, BladderPath, presented by Nicholas James, compared the traditional diagnostic pathways with the early use of multiparametric MRI. The MRI approach reduced the risk of bladder cancer specific deaths by 64% and significantly shortened the time to definitive treatment. This represents a concrete improvement in diagnosis accuracy and patient flow.

Overall, ESMO 2025 has transformed the paradigm in bladder cancer with EV plus pembrolizumab setting a new standard, ADC plus immunotherapy expanding treatment options, ctDNA guides adjuvant decisions and MRI improves early management. From Berlin, I’m Natalia Gandur and these were the most relevant advances in this tumour presented at ESMO 2025. Thank you for your attention.