“Few fields in oncology are moving as rapidly as bladder cancer. From perioperative treatment to metastatic disease, the consistent message from ASCO 2026 was that deeper responses are translating into longer survival, and increasingly into the possibility of longer-term disease control.”
Bladder cancer’s treatment landscape is changing fast; and the biggest abstracts presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago show just how far that shift now extends. New data on antibody-drug conjugate–immunotherapy combinations, perioperative intensification and long-term non-muscle-invasive bladder cancer outcomes highlight a field moving decisively towards earlier and more intensive systemic strategies. With insight from our Editor-in-Chief, Prof Axel S Merseburger (University Hospital Schleswig-Holstein, Germany), we examine the four studies likely to have the biggest impact on clinical practice across advanced and localized disease: EV-302, KEYNOTE-905, SAKK 06/19 and POTOMAC.
touchONCOLOGY coverage of ASCO 2026
EV-302
→ Abstract 4507: Powles T, Van Der Heijden MS, Bedke J, et al. Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the phase 3 EV-302 study. Presented at: ASCO, Chicago, IL, USA. May 29 to June 2, 2026
Updated 3.5-year follow-up from EV-302/KEYNOTE-A39 (NCT04223856) continues to support Enfortumab vedotin plus Pembrolizumab as first-line therapy in locally advanced or metastatic urothelial carcinoma. With a median follow-up of 42.8 months, median overall survival (OS) was 33.6 months with EV+P versus 15.9 months with chemotherapy, corresponding to a hazard ratio (HR) of 0.53 (95% CI, 0.45–0.63). The 42-month OS rate was 44.0% versus 24.6%, respectively. Among responders, 45.1% achieved complete response (CR) in the EV+P arm versus 32.8% with chemotherapy. Notably, 66.2% of patients with confirmed CR in the EV+P arm first achieved partial response (PR) before converting to CR after a median of 5 additional EV cycles (IQR, 3.0–8.0). No new safety signals were observed.
Key clinical takeaways
These data reinforce the durability of benefit with EV+P and provide important context around treatment duration. The observation that two-thirds of CRs emerged after an initial PR suggests that maintaining treatment in responding patients may be clinically relevant where tolerability permits. The long-term survival tail remains notable, with more than 80% of patients in the PR-to-CR subgroup alive at 3.5 years.
KEYNOTE-905
→ Abstract 4510: O’Donnell PH, Adra N, Alimohamed N, et al. Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: Phase 3 KEYNOTE-905 study. Presented at: ASCO, Chicago, IL, USA. May 29 to June 2, 2026
The phase III KEYNOTE-905/EV-303 study (NCT03924895) previously demonstrated significant improvements in event-free survival, OS, and pathologic complete response with neoadjuvant-adjuvant EV plus pembrolizumab plus radical cystectomy compared with surgery alone in cisplatin-ineligible or cisplatin-declining MIBC. At ASCO 2026, investigators presented prespecified exploratory health-related quality-of-life (HRQoL) data. Using EQ-5D-5L, FACT-Bl-Cys, FACT-G, and the Bladder Cancer Index (BCI), mean changes from baseline to post-surgery week 18 were reported as similar between treatment arms. Completion and compliance rates were ≥65% in the EV+pembrolizumab arm and >86% in the control arm. BCI sexual and bowel score diminution was observed in both arms.
Key clinical takeaways
The HRQoL findings suggest that adding perioperative systemic therapy did not result in measurable deterioration in patient-reported outcomes relative to surgery alone at the analysed timepoint. This is relevant given the efficacy improvements previously reported. The consistency of bowel and sexual function decline across both arms is aligned with the known impact of radical cystectomy and may help contextualise treatment discussions.
SAKK 06/19
→ Abstract 4503: Cathomas R, Petrausch U, Hayoz S. Intravesical recombinant BCG combined with chemo-immunotherapy (chemo-IO) as perioperative therapy for patients with muscle-invasive bladder cancer (MIBC): Primary analysis of SAKK 06/19. Presented at: ASCO, Chicago, IL, USA. May 29 to June 2, 2026
The single-arm phase II SAKK 06/19 study (NCT04630730) evaluated intravesical recombinant BCG (VPM1002BC) combined with Atezolizumab, cisplatin, and gemcitabine in 47 patients with cT2-T4a N0-1 MIBC. Of the 40 patients who underwent radical cystectomy, centrally reviewed pathologic complete response (pCR) was 65% (26/40; one-sided 95% CI lower boundary of 51%), while pathologic response (≤ ypT1N0) was 80% (32/40). Across all enrolled patients, pCR was 55% (26/47). Treatment delivery was high: 95% received rBCG, 98% received four doses of atezolizumab, and 95% completed four cycles of platinum-based chemotherapy. At a median follow-up of 11.8 months, 1-year event-free survival was 88% (95% CI 71–95) and OS was 95% (95% CI 81–99).
Key clinical takeaways
This study introduces a novel strategy integrating intravesical immune priming with systemic chemo-immunotherapy. Although limited by its single-arm design and short follow-up, the centrally assessed pCR rate of 65% is notable and supports further study. Whether recombinant BCG adds incremental benefit over established perioperative regimens will require comparative evaluation.
POTOMAC
→ Abstract 4624: de Santis M, Shore ND, Nishiyama H. Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. Presented at: ASCO, Chicago, IL, USA. May 29 to June 2, 2026
The phase III POTOMAC study (NCT03528694) evaluated Durvalumab plus BCG in BCG-naive high-risk non–muscle-invasive bladder cancer (NMIBC). At a median follow-up of 72 months, the updated OS analysis showed an HR of 0.81 (95% CI, 0.54–1.19), with 5-year OS rates of 87.6% (95% CI, 83.5%–90.8%) for durvalumab plus BCG induction and maintenance versus 86.3% (95% CI, 82.1%–89.6%) for BCG alone. Median OS was not reached in either arm. Patient-reported outcome analyses showed overall deterioration in EORTC QLQ-C30 scores in both groups, with clinically meaningful fatigue deterioration suggested in the durvalumab arm, although differences between arms were small. QLQ-NMIBC24 and PRO-CTCAE findings were similar between arms.
Key clinical takeaways
These long-term data provide reassurance that adding one year of durvalumab to BCG does not appear to adversely affect survival or substantially alter patient-reported quality of life. In the context of previously reported disease-free survival improvement, this supports the regimen’s longer-term tolerability profile, although mature survival differences remain unresolved.
This content has been developed independently by Touch Medical Media for touchONCOLOGY. This article was created by the editorial team utilizing AI as an editorial tool (ChatGPT 5.5 [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Cite: Bladder cancer at ASCO 2026: The breakthroughs that matter most. touchONCOLOGY. 17th June 2026.
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Editor: Sophie Nickelson.
