At the European Society for Medical Oncology (ESMO) 2025 congress, advances in bladder cancer took centre stage. From perioperative antibody–drug conjugates in cisplatin-ineligible patients, to ctDNA-guided adjuvant therapy and optimized MRI-based diagnostics, a series of late-breaking presentations showcased important new data. Below, we break down some of the most important trial updates and highlights.
Prof Axel S Merseburger (University Hospital Schleswig-Holstein, Lübeck, Germany)
“ESMO25 marked an important year for the bladder cancer field, showcasing innovative ways of thinking, precision medicine and integration across every disease stage”
KEYNOTE-905 (LBA2)
Click here to read our full interview with Prof Christof Vulsteke on the KEYNOTE-905 trial
The KEYNOTE-905 trial stole the spotlight in muscle-invasive bladder cancer (MIBC), demonstrating that perioperative enfortumab vedotin plus pembrolizumab achieved unprecedented efficacy in cisplatin-ineligible patients. Presented by Prof Christof Vulsteke (Integrated Cancer Centre Ghent, Ghent University Hospital, Belgium), the phase III study showed a pathologic complete response (pCR) rate of 57% versus 8.6% with surgery alone, alongside a two-year event-free survival (EFS) hazard ratio of 0.40 and overall survival (OS) HR of 0.50. The regimen’s tolerability and absence of surgical delay led leading experts to hail it as a new standard of care for this population.
ALBAN (LBA107)
Click here to read our full interview with Prof Morgan Rouprêt on the ALBAN trial
The ALBAN trial is an ongoing phase III, randomized, open-label, international study evaluating whether adding intravenous atezolizumab to intravesical Bacillus Calmette-Guérin (BCG) improves outcomes in BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). Conducted across 517 patients, the study compares BCG alone versus BCG plus atezolizumab for one year following transurethral resection of bladder tumour (TURBT). The primary endpoint is EFS. Early results presented at ESMO25 showed no EFS benefit with the combination, but the trial’s ongoing correlative analyses aim to identify biomarkers that could guide personalized immunotherapy approaches in NMIBC. Completion is expected by 2028.
BladderPath (LBA111)
Click here to read our full interview with Prof Nicholas D. James on the BladderPath trial
The BladderPath trial, presented as an ESMO25 Late-Breaker by Prof Nicholas D. James (Institute of Cancer Research & Royal Marston Hospital, London, UK), evaluated the impact of introducing MRI before TURBT in patients with suspected muscle-invasive bladder cancer. Traditionally, diagnosis-to-treatment takes over 130 days. Incorporating pre-treatment MRI reduced this to 95 days, improved staging accuracy, and halved the risk of relapse compared with standard care. The MRI-informed approach enabled faster, more targeted treatment decisions while reducing unnecessary TURBT procedures. It also proved cost-effective within the NHS, suggesting that integrating MRI into the bladder cancer pathway can improve patient outcomes, optimise theatre use, and streamline healthcare delivery.
RC48-C016 (LBA7)
In advanced disease, the Chinese RC48-C016 trial of disitamab vedotin plus toripalimab – a HER2-directed antibody–drug conjugate combined with PD-1 blockade – achieved progression-free survival (PFS) of 13.1 months versus 6.5 months and OS of 31.5 versus 16.9 months (HR 0.54) versus chemotherapy. The benefit was consistent across HER2-expressing subgroups, including cisplatin-ineligible and upper tract cases, and was accompanied by lower grade ≥3 toxicity (55% vs 87%). Commentators drew parallels to EV + pembrolizumab, suggesting disitamab-based combinations may soon rival EV-based regimens.
IMvigor011 (LBA8)
The IMvigor011 trial, presented by Professor Thomas Powles (Barts Cancer Institute, London, UK) validated ctDNA as a predictive biomarker for adjuvant therapy selection in MIBC. Among ctDNA-positive patients post-cystectomy, adjuvant atezolizumab improved disease-free survival (DFS, HR 0.64) and OS (HR 0.59) versus placebo, while ctDNA-negative patients demonstrated excellent natural outcomes – potentially sparing them unnecessary immunotherapy. This landmark result introduces a personalized, biomarker-guided approach to adjuvant therapy in urothelial carcinoma.
POTOMAC (LBA108)
The POTOMAC trial extended immunotherapy into non–muscle-invasive disease, showing that durvalumab plus BCG significantly improved DFS in BCG-naïve, high-risk NMIBC (HR 0.68; p=0.015) compared with BCG alone. Though OS data remain immature, the combination’s favorable tolerability profile supports durvalumab as a potential new option in early-stage disease.
DISCUS (LBA109)
De-escalation strategies also gained traction with DISCUS, a phase II trial showing that three cycles of platinum-based chemotherapy before avelumab maintenance preserved efficacy and improved quality of life compared with six cycles in advanced urothelial carcinoma. ‘Less can be more’ – particularly in the era of combination immunotherapy and antibody-drug conjugates (ADCs).
ESMO 2025 showcased an era of therapeutic precision and rational integration – where ADCs, biomarker-guided immunotherapy and targeted or radioligand strategies are converging to transform GU cancer management across disease stages.
Disclosure: This short article was prepared by touchONCOLOGY in collaboration with Prof Axel Merseburger. touchONCOLOGY utilize AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat). The content was developed and edited by human editors. No fees or funding were associated with its publication.
This content has been developed independently by Touch Medical Media for touchONCOLOGY. It is not affiliated with the European Society for Medical Oncology (ESMO). Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
Cite: ESMO25 GU round-up: Trials shaping the future of bladder cancer. touchONCOLOGY. November 13th, 2025
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