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Highlights from the American Urological Association's 2026 Annual Meeting
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| Practice-Changing, Paradigm-Shifting Clinical Trials in Urology: Durvalumab with BCG Therapy for High-Risk Nonmuscle-Invasive Bladder Cancer: Expanded Efficacy and Safety Analyses from POTOMAC
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| Neal Shore, MD, FACS
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| Neal Shore presents expanded efficacy and safety analyses from the phase 3 POTOMAC trial evaluating 1 year of durvalumab added to BCG induction + maintenance in BCG‑naïve, high‑risk NMIBC. The data shows that durvalumab + BCG reduces the risk of high‑risk disease recurrence or death by 32%, lowers early high‑risk recurrences and BCG‑unresponsive events, trends toward fewer and delayed cystectomies, and delivers consistent disease‑free survival benefit across papillary subgroups with a manageable immune‑related safety profile.
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| Practice-Changing, Paradigm-Shifting Clinical Trials in Urology: Intravenous Pembrolizumab Combined with Intravesical BCG for Patients with BCG-Naïve “Very High-Risk” T1 NMIBC
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| Eugene Pietzak, MD
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| Eugene Pietzak presents results from a single-arm phase II trial of intravenous pembrolizumab combined with intravesical BCG in BCG‑naïve patients with “very high‑risk” T1 NMIBC who declined upfront cystectomy. The author shows a 92% clinical complete response rate at 6 months with no progression to muscle‑invasive or metastatic disease at a median 22‑month follow‑up, suggesting durable disease control versus historical BCG alone, albeit with a notable rate of grade 3+ immune‑related adverse events.
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| Thermo-Sensitive Hydrogel System Enables Sustained Intravesical Delivery of Antibody–Drug Conjugates for Effective Treatment of Nonmuscle-Invasive Bladder Cancer
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| Shi Fu, MD
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| Shi Fu presents preclinical data on a thermo-sensitive ALG-NIPAM hydrogel platform designed to enable sustained intravesical delivery of antibody–drug conjugates for non–muscle-invasive bladder cancer. The study shows that hydrogel-encapsulated disitamab vedotin maintains antibody stability, achieves prolonged bladder residence with controlled release, and delivers antitumor activity equal or superior to free drug in vitro and in vivo, with durable immunogenic cell death and no apparent increase in systemic toxicity, supporting this as a promising strategy to optimize intravesical ADC therapy.
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| Improved Outcomes in High-Risk Nonmuscle-Invasive Bladder Cancer with Oral 5- Aminolevulinic Acid Fluorescence Cystoscopy–Assisted Transurethral Resection of Bladder Tumors
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| Takumi Okazaki, MD
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| Takumi Okazaki presents a single-center study evaluating oral 5-ALA fluorescence cystoscopy–assisted TURBT versus standard white-light TURBT in primary NMIBC. This study showed that fluorescence guidance modestly upgrades CUETO risk classification in a small subset of patients by detecting otherwise occult disease, and is associated with significantly improved recurrence-free and progression-free survival specifically in high- and very high-risk NMIBC, suggesting its greatest clinical value in these higher-risk populations.
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| Association of a Computational Histology AI (CHAI) Prognostic Biomarker with High-Grade Recurrence Independent of Traditional Risk Factors in Low-Grade Nonmuscle-Invasive Bladder Cancer
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| Roger Li, MD,
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| Roger Li presents results from development and validation of a Computational Histology AI (CHAI)–based prognostic biomarker that uses routine pretreatment H&E slides to risk-stratify patients with low-grade NMIBC for future high-grade recurrence. The data shows that CHAI-positive patients have a markedly higher 36‑month grade progression risk and significantly worse high‑grade recurrence–free survival, with the biomarker retaining independent prognostic value beyond traditional clinicopathologic and IBCG risk factors, supporting its potential role as a precision tool to guide treatment intensification or closer surveillance.
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| ADVANCED-2 (Cohort B): Interim Efficacy and Safety Data in BCG-Unresponsive Participants with High-Grade Nonmuscle-Invasive Bladder Cancer
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| Timothy Clinton, MD
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| Timothy Clinton presents interim phase 2 data from ADVANCED-2 Cohort B evaluating intravesical TARA-002 in patients with BCG-unresponsive high-grade NMIBC with CIS ± Ta/T1. This data shows that TARA-002 achieved a 65.7% high-grade complete response rate at any time, with durable responses out to 12 months in initial responders and a 61.5% conversion to complete response after re-induction among initial non-responders, alongside a favorable safety profile with only low-grade, transient treatment-related adverse events.
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| Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Nonmuscle-Invasive Bladder Cancer Carcinoma In-Situ
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| Wassim Kassouf, MD, CM, FRCSC
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| Wassim Kassouf presents interim phase II results of intravesical, light-activated TLD-1433 photodynamic therapy in patients with BCG-unresponsive high-risk NMIBC with CIS ± Ta/T1 disease. The study shows a 65.2% complete response rate at any time, with 40.4% of responders maintaining complete response at 450 days and a subset sustaining durable responses out to 2–3 years, alongside a manageable safety profile dominated by transient lower urinary tract symptoms, supporting TLD-1433 as a promising bladder-sparing option in this challenging population.
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| Blue Light Cystoscopy Enables Earlier CIS Recognition and Can Guide Risk-Appropriate Management of High-Risk Nonmuscle-Invasive Bladder Cancer: Real-World Outcomes from a U.S. Claims Cohort
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| Mark Tyson II, MD, MPH
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| Mark Tyson presents a large real‑world U.S. claims analysis comparing blue light cystoscopy with standard white light cystoscopy in high‑risk NMIBC. The author shows that BLC is associated with significantly higher early CIS detection, greater and earlier BCG use, and higher early cystectomy rates, suggesting that enhanced visualization with BLC enables earlier recognition of occult high‑risk disease and helps guide more risk‑appropriate management in routine practice.
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