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| Phase 2 Trial of Neoadjuvant Nivolumab and Visugromab in Bladder Cancer Patients |
| Andrea Necchi, MD |
| Andrea Necchi presents GDFATHER-NEO trial results, evaluating neoadjuvant nivolumab plus visugromab versus nivolumab-placebo in 31 cisplatin-ineligible/refusing muscle-invasive bladder cancer patients. |
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Highlights from the 2025 European Society of Medical Oncology Annual Meeting |
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| Perioperative EV + Pembro in Participants with MIBC Who Are Cisplatin-Ineligible: The Phase 3 KEYNOTE-905 Study |
| Christof Vulsteke, MD, PhD
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| The phase 3 KEYNOTE-905 trial showed that perioperative enfortumab vedotin plus pembrolizumab significantly improved event-free survival, overall survival, and pathological complete response rates in cisplatin-ineligible or cisplatin-declining patients with muscle-invasive bladder cancer compared to surgery alone. Median EFS and OS were not reached with the combination, and the pCR rate reached 57.1%, the highest reported in an MIBC phase 3 trial.
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| KEYNOTE-905 Study Discussion - Perioperative EV + Pembro in Participants with MIBC Who Are Cisplatin-Ineligible |
| Jonathan Rosenberg, MD |
| Jonathan Rosenberg presented the phase 3 KEYNOTE-905 trial, which showed that perioperative enfortumab vedotin (EV) plus pembrolizumab significantly improved event-free survival (HR 0.40), overall survival (HR 0.5), and pathologic complete response rates (>50%) in cisplatin-ineligible patients with muscle-invasive bladder cancer. The regimen was safe, feasible, and well-tolerated even in older, comorbid patients, without compromising surgical outcomes. |
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| EV + Pembro in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer: An Exploratory Analysis in Older Patients and Those With Comorbidities from EV-302 |
| Nataliya Mar, MD
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| Nataliya Mar presented an exploratory analysis from EV-302, showing that enfortumab vedotin plus pembrolizumab (EV+P) maintains its strong efficacy and safety across challenging subgroups of patients with locally advanced or metastatic urothelial carcinoma, including those ≥75 years old, with diabetes, or with renal impairment. EV+P achieved notably higher response rates and sustained PFS and OS advantages over chemotherapy in all groups.
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| EV-103 Cohort K: Efficacy and Safety of EV with or without Pembro in Cisplatin-Ineligible Patients with Previously Untreated Locally Advanced or Metastatic Urothelial Cancer with a Median Follow-Up of ≈3.5 Years
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| Terence Friedlander, MD
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| Terence Friedlander presented updated 3.5-year results from EV-103 Cohort K, showing that enfortumab vedotin plus pembrolizumab (EV+P) provides durable and superior outcomes compared to EV alone in cisplatin-ineligible, previously untreated locally advanced or metastatic urothelial carcinoma. EV+P achieved higher response rates, longer PFS, and OS with a manageable safety profile.
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| Efficacy and Safety Results from Formula-01: A Phase II Study of Disitamab Vedotin plus BCG in HER2 High Expression High-Risk NMIBC Patients
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| Xingliang Tan, MD
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| Xingliang Tan presented results from the phase II Formula-01 trial, which evaluated disitamab vedotin (DV) plus BCG in HER2-high, high-risk NMIBC. Among 78 patients, the 12-month disease-free survival was 92%, with only 3% treatment failure in the per-protocol group and no deaths reported. The combination showed strong efficacy and manageable toxicity, with mostly grade 1–2 side effects such as fatigue and neuropathy, supporting DV + BCG as a promising option for this biomarker-defined subgroup.
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| Association of Molecular Markers with Clinical Response to TAR-200 in the Phase 2b SunRISe-1 Trial in Patients with BCG-Unresponsive NMIBC with CIS, with or without Papillary Disease
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| Felix Guerrero-Ramos, MD, PhD, FEBU
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| Felix Guerrero-Ramos presented an exploratory analysis from the phase 2b SunRISe-1 trial, evaluating molecular correlates of response to TAR-200, a sustained-release intravesical gemcitabine delivery system, in BCG-unresponsive NMIBC with CIS ± papillary disease. Among 63 patients analyzed, complete response was 84% with a median duration of 25.8 months, and no significant associations were found between genomic alterations, PD-L1 expression, TMB, MSI status, or utDNA MRD and clinical outcomes.
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