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| Final Results of the SunRISe-4 Study in Muscle-Invasive Bladder Cancer |
| Andrea Necchi, MD |
| Andrea Necchi presents final SunRISe-4 results, evaluating neoadjuvant gemcitabine intravesical system (TAR-200) plus cetrelimab versus cetrelimab monotherapy in cisplatin-ineligible/refusing muscle-invasive bladder cancer patients. |
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Highlights from the 2025 European Society for Medical Oncology Annual Meeting |
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| Disitamab Vedotin plus Toripalimab Versus Chemotherapy in First-Line Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) with HER2-Expression |
| Jun Guo, MD |
| Jun Guo presented results from the phase III RC48-C016 trial, showing that disitamab vedotin plus toripalimab (DV+T) significantly improved progression-free survival and overall survival compared to chemotherapy in first-line HER2-expressing locally advanced or metastatic urothelial carcinoma. The benefits were consistent across HER2 expression levels, with a higher response rate and fewer grade ≥3 adverse events. DV+T demonstrated superior efficacy and tolerability, establishing it as a potential new standard of care for this population. |
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| Discussant – Disitamab Vedotin plus Toripalimab Versus Chemotherapy in First-Line Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) with HER2-Expression |
| Andrea Necchi, MD |
| Andrea Necchi discussed the RC48-C016 trial, which compared disitamab vedotin + toripalimab to chemotherapy in first-line HER2-expressing locally advanced or metastatic urothelial carcinoma. He acknowledged the trial’s strong PFS and OS benefits versus chemotherapy but questioned its global applicability, noting similar relative efficacy to enfortumab vedotin + pembrolizumab without the need for biomarker selection. |
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| IMvigor011: A Phase 3 Trial of ctDNA-Guided Adjuvant Atezolizumab versus Placebo in MIBC |
| Thomas Powles, MBBS, MRCP, MD |
| Thomas Powles presented results from the IMvigor011 phase 3 trial, showing that ctDNA-guided adjuvant atezolizumab significantly improved disease-free and overall survival versus placebo in ctDNA-positive muscle-invasive bladder cancer after cystectomy. Patients who remained ctDNA-negative had excellent outcomes without adjuvant therapy, underscoring the value of ctDNA monitoring for tailoring post-surgical treatment. |
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| Discussant: Precision in the Adjuvant Gap – IMvigor011 and ctDNA+ MIBC |
| Alexander Wyatt, PhD, D.Phil |
| Alexander Wyatt discussed IMvigor011, highlighting it as the first phase III trial to show that ctDNA-guided adjuvant immunotherapy significantly improves survival in muscle-invasive bladder cancer (MIBC) based on molecular evidence of disease rather than clinicopathologic risk. He emphasized that serial ctDNA testing enables precise patient selection, identifying ctDNA+ patients who benefit from therapy while safely sparing ctDNA− patients from overtreatment. |
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| PUNCH02: Interim Results from a Phase II study of Tislelizumab Combined with Disitamab Vedotin as a Bladder Preservation Therapy for Urine Tumor DNA (utDNA)-defined Clinical Complete Response (cCR) MIBC Patients |
| Bin Huang, MD |
| The phase II PUNCH02 trial evaluated tislelizumab plus disitamab vedotin (RC48) as a bladder-preserving therapy for Her2-positive MIBC patients achieving a urine tumor DNA (utDNA)-defined complete response after TURBT. Among 28 patients, the utDNA-defined cCR rate was 71.4%, reaching 89% in Her2(3+) and 100% in solitary tumors, with all utDNA-negative patients maintaining bladder preservation. |
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| Artificial Intelligence Predicts Molecular Subtypes and Outcomes in Muscle-Invasive Bladder Cancer from Whole Slide Images |
| Alice Blondel |
| Alice Blondel presented an AI-based deep learning model that accurately predicts molecular subtypes and outcomes in muscle-invasive bladder cancer (MIBC) directly from standard H&E slides, eliminating the need for RNA sequencing. Trained on the VESPER cohort and validated across multiple external datasets, the model achieved an AUC of 0.94 and showed strong correlation with spatial transcriptomics and patient survival data. |
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| Impact of Dose Reductions on the Efficacy of Erdafitinib in Patients with Advanced or Metastatic Urothelial Carcinoma (mUC): A Post-hoc Analysis of the Phase 3 THOR Study Cohort-1 Evaluating Erda versus Chemotherapy (Chemo) |
| Patrizia Giannatempo, MD |
| Patrizia Giannatempo presented a post-hoc analysis of the phase 3 THOR trial, evaluating the impact of erdafitinib dose reductions in FGFR3-altered advanced or metastatic urothelial carcinoma. Among 136 patients, nearly half required at least one dose reduction, primarily for stomatitis, hand-foot syndrome, or nail toxicities. Notably, patients with ≥2 dose reductions had the longest median OS and PFS, indicating that dose reductions did not compromise efficacy and supporting proactive toxicity management to maintain treatment benefit. |
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| Circulating Immune-Biomarkers of Response to Neoadjuvant Sacituzumab Govitecan Alone and with Pembrolizumab in Muscle-Invasive Bladder Cancer (MIBC): Secondary Analyses from SURE-01 and SURE-02 Trials |
| Giovanni Luigi Pastorino |
| Giovanni Luigi Pastorino presented secondary biomarker analyses from SURE-01 (sacituzumab govitecan [SG]) and SURE-02 (SG + pembrolizumab) trials in muscle-invasive bladder cancer. Results showed that lower baseline levels of PMN-MDSCs and CD16⁺CD14⁻ mononuclear cells correlated with major response in patients receiving SG + pembrolizumab, but not SG alone. |
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| Perioperative Chemo-Immunotherapy with Durvalumab for Operable Muscle-Invasive Urothelial Carcinoma (MIUC): Final Analysis of the Single Arm Phase II Trial SAKK 06/17
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| Richard Cathomas, MD
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| Richard Cathomas presented the final results of the SAKK 06/17 phase II trial evaluating perioperative durvalumab plus gemcitabine/cisplatin in resectable muscle-invasive urothelial carcinoma (MIUC). After a median follow-up of 64 months, 5-year event-free and overall survival rates were 73.6% and 75.4%, respectively, with outcomes strongly linked to pathological downstaging.
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| Intravesical Recombinant BCG Followed by Perioperative Chemo-Immunotherapy (Chemo-IO) for Patients with Muscle-Invasive Bladder Cancer (MIBC): Interim Analysis of SAKK 06/19 Study |
| Richard Cathomas, MD |
| Richard Cathomas presented the SAKK 06/19 interim analysis evaluating intravesical recombinant BCG followed by perioperative gemcitabine/cisplatin plus atezolizumab in muscle-invasive bladder cancer. Among 24 patients analyzed, the regimen showed high treatment completion rates, acceptable toxicity, and a promising pathological complete response. The approach was deemed feasible and safe, meeting predefined criteria for continuation into stage 2 of the trial. |
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| Avelumab First-Line Maintenance Treatment for Advanced Urothelial Carcinoma in France: Conditional Survival and Long-Term Safety in Patients Treated for ≥1 or ≥2 Yrs in the AVENANCE Real-World Study
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| Constance Thibault, MD
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| Constance Thibault presented real-world data from the AVENANCE study evaluating avelumab first-line maintenance in patients with advanced urothelial carcinoma treated for ≥1 or ≥2 years. Patients treated for 1 year had an 87.7% probability of surviving an additional year, and those treated for 2 years had a 90.3% probability, with similarly high chances of remaining progression-free. Long-term safety was favorable, with serious treatment-related adverse events being rare, confirming durable effectiveness and tolerability consistent with the JAVELIN Bladder 100 trial.
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| Cost-Effectiveness Analysis of Perioperative Durvalumab plus Platin-Based Chemotherapy in Muscle Invasive Bladder Cancer |
| Constantin Rieger, MD |
| Constantin Rieger presented a cost-effectiveness analysis of adding durvalumab to neoadjuvant gemcitabine/cisplatin for muscle-invasive bladder cancer in Germany. The analysis showed that durvalumab plus Gem/Cis was cost-effective, with an incremental cost of €13,162 and an ICER of €61,006 per QALY gained, providing modest survival benefits while reducing downstream metastatic treatment costs. Overall, the study highlights the economic and clinical value of perioperative durvalumab in preventing progression to metastatic disease within commonly accepted willingness-to-pay thresholds. |
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| The Feasibility of Wearable Devices to Assess Patient Reported Outcomes in Urothelial Cancer Trials: The DISCUS Substudy |
| Francesca Jackson-Spence, MBChB, BMedSc, PGCAP |
| Francesca Jackson-Spence presented the DISCUS wearable device substudy, evaluating the feasibility of using wearables and app-based questionnaires to monitor patient-reported outcomes (PROs) in advanced bladder cancer trials. Among 52 enrolled patients, 56% met compliance criteria for both wearable use and PRO completion, with barriers mainly due to connectivity issues, illness, and technological challenges. |
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| EORTC GUCG 2418 STARBUST: Strategies for Treatment Adaptation Following Re-Evaluation of the Bladder After Using pRimary Neoadjuvant Systemic Therapies: An EORTC Platform Trial |
| Guillaume Grisay, MD, PhD |
| Guillaume Grisay presented the EORTC GUCG 2418 STARBUST platform trial, designed to optimize treatment adaptation in MIBC after neoadjuvant systemic therapy. STARBUST-1 is a single-arm phase II study evaluating the ability of multimodal assessment—including mpMRI (NacVI-RADS), cystoscopy, urine/blood biomarkers, and radiomics/pathomics—to predict pathological complete or near-complete response, guiding potential bladder-sparing strategies. |
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| INTerpath-011: A Phase 2 Study of Intismeran Autogene (V940/mRNA-4157) + BCG Versus BCG Alone for High-Risk NMIBC |
| Petros Grivas, MD, PhD |
| Petros Grivas presented INTerpath-011, a phase 2 trial evaluating intismeran autogene plus BCG versus BCG alone in high-risk non–muscle invasive bladder cancer. The personalized neoantigen therapy is designed to enhance BCG-induced antitumor T-cell responses, with cohort A comparing BCG ± intismeran in ~278 BCG-naive patients and cohort B exploring intismeran monotherapy in ~30 BCG-naive or exposed patients. |
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