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Highlights from the 2025 European Association of Urology Annual Meeting |
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| Updated Clinical & Translational Results: BOND-003 Cohort C: A Phase 3, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for High-Risk BCG-Unresponsive NMIBC with CIS |
| Trinity Bivalacqua, MD, PhD |
| Trinity Bivalacqua presented updated results from the BOND-003 cohort C study at EAU 2025, evaluating the efficacy and safety of intravesical cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer with CIS. The study showed a complete response rate of 75.5% at any time, with 46% maintaining a response at 12 months, and 97.3% freedom from progression to muscle-invasive cancer. |
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| Definitions, Outcomes and Treatment of BCG Unresponsive NMIBC |
| Peter Black, MD |
| Peter Black discussed definitions, outcomes, and treatment options for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). While radical cystectomy remains the standard treatment, alternative bladder-preserving therapies, including intravesical chemotherapy (gemcitabine + docetaxel), immune checkpoint inhibitors (pembrolizumab, nadofaragene firadenovec, N-803), and novel agents like TAR-200, are gaining traction. |
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| The Need to De-Escalate Follow-up in the Growing Population of NMIBC Patients: Urine Diagnostics |
| Evanguelos N. Xylinas, MD, MS |
| Evanguelos Xylinas highlighted the need to de-escalate follow-up in NMIBC patients due to the economic and patient burden of frequent cystoscopy. He reviewed various urine-based diagnostic tests, including NMP22, UroVysion, ADXBLADDER, Bladder EpiCheck, Xpert Bladder Cancer Monitor, and VisioCyt, noting their potential in surveillance. |
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| Combination Therapy: Systemic Versus Intravesical - It Takes Two to Tango: Systemic and Intravesical Therapy - the Ideal Duo for Treatment of HR-NMIBC
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| Yohann Loriot, MD, PhD
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| Yohann Loriot’s presentation at EAU 2025 highlighted the potential of combining systemic and intravesical therapies for high-risk non-muscle invasive bladder cancer (HR-NMIBC). While BCG remains the cornerstone of treatment, trials like KEYNOTE-057, BladderGATE, and SunRISe suggest that adding systemic PD(L)1 inhibitors or targeted agents may improve outcomes, though toxicity remains a concern.
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| Combination Therapy: Systemic Versus Intravesical - the Dynamic Duo: Gemcitabine and Docetaxel - The Bladder Is Their Domain!
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| Marco Moschini, MD, PhD
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| Marco Moschini’s presentation at EAU 2025 highlighted gemcitabine and docetaxel as a promising intravesical chemotherapy combination for non-muscle invasive bladder cancer (NMIBC). Retrospective and multicenter studies show strong recurrence-free survival rates, particularly in high-risk BCG-naïve patients, with some trials reporting a 100% complete response at 3 months.
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| Combination Therapy: Systemic Versus Intravesical - BCG Unleashed: Harnessing Local Immunomodulators for Maximum Impact |
| Trinity Bivalacqua, MD, PhD |
| This session highlighted advances in intravesical therapy for bladder cancer, emphasizing how BCG can be enhanced with local immunomodulators. The phase 3 CREST trial showed that combining sasanlimab (anti-PD-1) with BCG significantly improved outcomes in high-risk NMIBC. Additionally, recombinant BCG approaches like BCG-STING and VPM1002 are being developed to generate a stronger localized immune response, potentially improving treatment for both BCG-naïve and unresponsive disease states. |
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| Gene Expression Signatures of Immune Infiltration Portend Differential Response to Sequential Intravesical Gemcitabine and Docetaxel versus BCG in High-Risk NMIBC |
| Joep de Jong, BSc |
| This study examined gene expression signatures to predict response to intravesical Gem/Doce versus BCG in high-risk NMIBC. Findings showed that patients with higher immune scores had significantly better high-grade recurrence-free survival with Gem/Doce than BCG, while those with lower immune scores had similar outcomes with both treatments. These results highlight the potential for immune profiling to guide treatment selection, warranting further validation in larger studies. |
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| The DaBlaCa-15 Trial: The Urinary Biomarker Test Xpert® Bladder Cancer Monitor for Guiding Cystoscopy in High-grade Non-muscle-invasive Bladder Cancer: Results from a Randomized Controlled Trial |
| Thomas Dreyer, MD, PhD |
| The DaBlaCa-15 trial evaluated the Xpert® Bladder Cancer Monitor as a non-invasive alternative to guide cystoscopy in high-grade NMIBC surveillance. Results showed no significant difference in recurrence-free survival between patients monitored with Xpert® and those undergoing routine cystoscopy, while the intervention arm had significantly fewer cystoscopies. |
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| Diagnostic Accuracy and Efficacy of Photodynamic Diagnosis 4-8 Hours After 5-Aminolevulinic Acid Hydrochloride Administration for Non-Muscle Invasive Bladder Cancer: An Exploratory Analysis of the Phase III SPP2C102 Trial |
| Rikiya Taoka, MD, PhD |
| The phase III SPP2C102 trial demonstrated that photodynamic diagnosis (PDD) using blue light (BL) imaging 4–8 hours after 5-ALA administration had a significantly higher sensitivity (95.3%) than white light (WL) imaging (61.1%) for detecting NMIBC. BL imaging was particularly superior for detecting flat tumors and was effective across all bladder anatomical sites except the bladder neck. |
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| PROGRxN-BCa, an Artificial Intelligence-Based Model to Predict Progression Risk in Non-Muscle Invasive Bladder Cancer and Improve Substratification of Intermediate-Risk Disease: An International Evaluation of 12659 Patients |
| Girish Kulkarni, MD, PhD |
| The PROGRxN-BCa, an AI-based model, outperformed existing tools in predicting progression risk in NMIBC, demonstrating about 10% higher accuracy across clinically relevant subgroups. Validated using data from 12,659 patients worldwide, the model also significantly improved the sub-stratification of intermediate-risk NMIBC, providing better differentiation between patients who would otherwise be classified similarly using traditional risk factors. |
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| Translational Correlates Using Urinary Genomic Disease Burden to Assess Cretostimogene Grenadenorepvec: Analysis from the BOND-003 and CORE-001 Trials |
| Sharada Mokkapati, MS, PhD |
| Sharada Mokkapati presented a translational analysis from the BOND-003 and CORE-001 trials at EAU 2025, showing that urinary genomic disease burden, measured with the UroAmp platform, correlates with clinical response to cretostimogene grenadenorepvec in BCG-unresponsive non-muscle invasive bladder cancer. The study found that minimal residual disease status was a strong predictor of clinical outcomes, with patients achieving complete responses showing a significant reduction in genomic disease burden at 3 and 6 months. |
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| Cost-Effectiveness Analysis of Treatments for BCG-Unresponsive High-Risk NMIBC |
| Amanda Myers, MD |
| Amanda Myers presented a cost-effectiveness analysis at EAU 2025, comparing treatments for BCG-unresponsive high-risk non-muscle invasive bladder cancer. The analysis showed that for different patient profiles, the most cost-effective treatment options varied: for patients willing to undergo radical cystectomy or 1-2 lines of therapy, gemcitabine + docetaxel and radical cystectomy were most cost-effective, while pembrolizumab was favored for patients declining cystectomy. |
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| First-in-Human Study of RAG-01, a Novel Small Activating RNA Therapeutic in BCG Failure NMIBC Patients |
| Paul Anderson, MBBS, FRACS |
| Paul Anderson presented a first-in-human study of RAG-01, a novel small activating RNA therapeutic targeting the p21 gene in patients with BCG failure non-muscle invasive bladder cancer at EAU 2025. The study, which showed no dose-limiting toxicities and a favorable safety profile, reported a 66.7% complete response rate for carcinoma in situ and disease-free survival for papillary tumors at 3 months. |
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