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Highlights from the 2025 American Urological Association Annual Meeting |
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| PIVOT-006: A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec Versus Surveillance for the Treatment of Intermediate-Risk NMIBC
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| Max Kates, MD
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| Max Kates presented PIVOT-006, a phase 3 randomized trial evaluating adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk NMIBC—a population with high recurrence but low progression risk. Cretostimogene, an oncolytic immunotherapy targeting Rb-E2F pathway-altered bladder cancer cells and expressing GM-CSF, may offer a novel, evidence-based approach to reduce recurrence in this understudied setting.
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| BOND-003 Cohort P- A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
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| Mark Tyson, II, MD, MPH
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| Mark Tyson presented BOND-003 Cohort P, a multinational phase II trial evaluating intravesical cretostimogene grenadenorepvec (CG), an oncolytic immunotherapy, in patients with high-risk, papillary-only BCG-unresponsive NMIBC. Early data from the first 24 patients showed a 90.5% high-grade recurrence-free survival at both 3 and 9 months, with no serious treatment-related adverse events or discontinuations, highlighting CG’s promising efficacy and favorable safety.
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| MoonRISe-1: Phase 3 Study of TAR-210, an Intravesical Erdafitinib Releasing System, Versus Intravesical Chemotherapy in Patients with FGFR-Altered Intermediate-Risk Non–muscle-Invasive Bladder Cancer
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| Roger Li, MD
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| Roger Li presented MoonRISe-1, a phase III trial evaluating TAR-210, a novel intravesical erdafitinib-releasing system, versus standard intravesical chemotherapy in patients with FGFR-altered intermediate-risk NMIBC. TAR-210 aims to provide sustained local FGFR inhibition with reduced systemic toxicity, following promising early data showing high complete response and durable benefit; the trial's primary endpoint is disease-free survival, with ongoing recruitment at 198 global sites.
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| Advanced-2: A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
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| Brian Mazzarella, MD
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| Brian Mazzarella presented ADVANCED-2, a phase II, open-label trial assessing intravesical TARA-002 in BCG-unresponsive patients with high-grade non–muscle-invasive bladder cancer (NMIBC). TARA-002, an immunopotentiator with a mechanism similar to BCG, is being tested for safety and efficacy, with primary endpoints focused on high-grade complete response; patients receive induction and maintenance therapy over 15 months, with mandatory biopsy at 3 months.
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| SunRISe-5: A Phase 3, Randomized, Open-Label Study of TAR-200 Compared with Intravesical Chemotherapy After Bacillus Calmette-Guérin in Recurrent High-Risk Non–muscle-Invasive Bladder Cancer |
| Sima Porten, MD, MPH |
| Sima Porten presented SunRISe-5, a phase III trial comparing TAR-200, a sustained intravesical gemcitabine delivery system, to standard intravesical chemotherapy in patients with papillary-only, high-risk NMIBC who recur within a year after BCG and are unfit or unwilling to undergo radical cystectomy. The trial addresses a major unmet need for bladder-sparing treatment options in this population, with the primary endpoint being disease-free survival. |
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| MoonRISe-3: Phase 3 Study of TAR-210 Intravesical Erdafitinib Releasing System versus Intravesical Chemotherapy in Patients with BCG–treated High-Risk NMIBC with Susceptible FGFR Alterations |
| Neal Shore, MD, FACS |
| Neal Shore presented MoonRISe-3, a phase III trial evaluating TAR-210, a novel intravesical erdafitinib-releasing system, versus standard intravesical chemotherapy in patients with FGFR-altered, papillary-only, high-risk NMIBC previously treated with BCG. Given the lack of approved therapies for this molecularly defined, BCG-experienced population, this study aims to assess whether targeted FGFR inhibition via sustained local delivery can improve disease-free survival while avoiding the morbidity of radical cystectomy. |
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| Prospective Open Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained Release Gemcitabine Docetaxel Combination (NDV-01) in High Risk NMIBC |
| Boris Chertin, MD |
| Boris Chertin presented early results from a prospective open-label study evaluating NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel, in high-risk NMIBC. Preliminary data show promising efficacy, with an 85% high-grade recurrence-free survival at 3 months and favorable safety in both BCG-naïve and BCG-unresponsive patients. NDV-01 offers a bladder-sparing, easily administered treatment option, though longer follow-up and additional enrollment are needed. |
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| NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance versus Treatment |
| Marie-Pier St-Laurent, MD |
| Marie-Pier St-Laurent presented the NEO-BLAST trial, which investigates whether patients with a complete clinical response to neoadjuvant therapy for muscle-invasive bladder cancer can safely undergo active surveillance instead of definitive treatment. Using a combination of ctDNA, MRI, cystoscopy/TURBT, and imaging to assess response, the trial aims to determine if surveillance is non-inferior to standard treatment in terms of 2-year metastasis-free survival. A multi-site launch is planned for July 2025 in British Columbia.4o |
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| NeoSTOP-IT: A Phase 2, Randomized, Open-Label Study of Gemcitabine/Cisplatin plus Cemiplimab (REGN2810, Anti-PD-1) with or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients with Localized Muscle-Invasive Bladder Cancer |
| Alexander Wei, MD |
| Alexander Wei presented the NeoSTOP-IT trial at AUA 2025, a phase 2 study investigating the combination of gemcitabine/cisplatin with cemiplimab (anti-PD-1) and fianlimab (anti-LAG-3) for organ preservation in localized muscle-invasive bladder cancer. The trial aims to evaluate clinical complete response rates, bladder-intact survival, recurrence-free survival, and safety, with a focus on whether this combination therapy can allow more patients to avoid radical cystectomy. |
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| State-of-the-Art Lecture: Urothelial Markers
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| Joshua Meeks, MD, PhD
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| Joshua Meeks delivered a comprehensive lecture on urothelial cancer biomarkers, highlighting advances across tissue, urine, and blood-based diagnostics. He emphasized the clinical utility of DDR gene alterations, ctDNA for real-time surveillance, AI-driven pathology for predicting BCG response, and emerging precision therapies like TAR-210 targeting FGFR3. These tools are shaping a future of personalized care, though challenges in implementation and interpretation remain.
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