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The 2026 European Association of Urology (EAU) Annual Meeting
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| Final Analysis of the Phase 1 First-in-Human Study of an Erdafitinib Intravesical Drug-Releasing System in Patients with NMIBC Harboring Select FGFR Alterations
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| Antoni Vilaseca, MD, PhD, MSc
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| This first-in-human phase 1 study of an intravesical erdafitinib drug‑releasing system in FGFR‑altered NMIBC showed it was generally well tolerated, with mostly grade 1–2 lower urinary tract symptoms and systemic erdafitinib levels over 40‑fold lower than oral dosing. Clinically, it achieved an estimated 12‑month recurrence‑free survival of about 83% in BCG‑treated high‑risk patients and an 89% complete response rate with a median 18‑month response duration in intermediate‑risk disease, supporting ongoing phase 2–3 MoonRISe trials as a bladder‑sparing, targeted option.
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| Fluorescence Cystoscopy and Adjuvant Optimized Mitomycin-C in Non-Muscle Invasive Bladder Cancer with High Risk of Recurrence: Results from the Prospective Randomized FinnBladder 9 Trial
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| Peter Bostrom, MD, PhD
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| The FinnBladder 9 randomized trial showed that in low‑grade NMIBC patients with high recurrence risk, only the combination of blue‑light TURBT plus six weekly optimized mitomycin‑C significantly reduced recurrences versus standard white‑light TURBT without adjuvant therapy. Other combinations (blue light alone or mitomycin‑C after white light) did not significantly change recurrence, and progression remained rare across all arms.
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| Holmium Laser En-Bloc Resection Versus Conventional TURBT for Large NMIBC: Safety and Mid-term Oncological Outcomes from a Prospective Randomized Trial
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| Maykon Pereira, MD
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| In this randomized trial of patients with bladder tumors larger than 3 cm, holmium laser en-bloc resection was as oncologically effective as conventional monopolar TURBT at roughly 3-year follow-up, with similar disease-free and overall survival. It showed important perioperative advantages, including markedly lower bladder perforation rates and shorter catheterization time, plus better specimen integrity and staging, making it a promising, safer alternative to standard TURBT for large NMIBC.
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| Phase 1/2 Study of an Anti-PD-L1/IL-15 Variant Fusion Protein (SIM0237) in BCG Unresponsive High-Risk NMIBC
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| Dingwei Ye, MD
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| This early phase 1/2 study suggests that intravesical SIM0237 is safe and generally well tolerated in BCG‑unresponsive high‑risk NMIBC, with mainly grade 1–2 urinary adverse events and no systemic drug exposure detected. It showed encouraging efficacy signals, including a high complete response rate in CIS patients and a roughly two‑thirds 12‑month disease‑free survival rate in papillary‑only disease, supporting movement to a planned phase 3 trial.
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| Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG Unresponsive Non-Muscle Invasive Bladder Cancer CIS
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| Girish Kulkarni, MD, PhD, FRCSC
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| In this phase II trial of light‑activated TLD‑1433 (Ruvidar) for BCG‑unresponsive NMIBC CIS, a single intravesical instillation plus intravesical laser activation achieved a complete response at some point in 64% of patients, with a median response duration of about 14 months and roughly one quarter of responders still disease‑free at 2–3 years.
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| Comparative Effectiveness of NAI +BCG versus Other Bladder-Sparing Therapies in BCG-Unresponsive NMIBC with CIS ± Ta/T1 Papillary Disease: An External Control Arm Study
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| Christian Doehn, MD
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| NAI + BCG, based on QUILT-3.032 with an external German control, achieved higher complete response rates and significantly better progression-free and disease-specific survival than other bladder-sparing options in BCG-unresponsive NMIBC with CIS ± papillary disease. It appears to offer a meaningful bladder-sparing alternative to radical cystectomy, though results come from indirect, retrospective comparison and should be interpreted cautiously.
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| BCG + Mitomycin Versus BCG Alone as Adjuvant Intravesical Therapy for High-Risk NMIBC: Effects on Urinary Symptoms and Other Aspects of Health Related Quality of Life in a Randomized Trial (ANZUP 1301)
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| Dickon Hayne, MD, FRCS
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| In ANZUP 1301, BCG + mitomycin provided similar or slightly better disease-free survival than BCG alone, while using 39% less BCG and having fewer treatment discontinuations. Urinary symptoms and broader health-related quality of life were overall similar between arms, with AUASI scores modestly favoring BCG + mitomycin, supporting it as a well‑tolerated, BCG‑sparing alternative for high‑risk NMIBC.
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