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HIGHLIGHTS FROM THE 2024 EUROPEAN ASSOCIATION OF UROLOGY ANNUAL MEETING |
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Basic Research and Trials – Non-Muscle Invasive Bladder Cancer
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| Results from SunRISe-1 in Patients with BCG-Unresponsive High-Risk Non–Muscle Invasive Bladder Cancer Receiving TAR-200 Monotherapy
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| Andrea Necchi, MD
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| Andrea Necchi presented results from the SunRISe-1 trial investigating TAR-200 monotherapy in patients with BCG-unresponsive high-risk non–muscle invasive bladder cancer. The study demonstrated a centrally assessed complete response rate of 76.7% with TAR-200, with durable responses lasting up to 12 months or more in 91% of patients. Adverse events were mainly low-grade and manageable, indicating TAR-200's potential as a well-tolerated treatment option for this patient population.
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| Trial in Progress: SunRISe-3: TAR-200 plus Cetrelimab or TAR-200 Versus Intravesical BCG in Patients with BCG-Naive High-Risk Non–Muscle Invasive Bladder Cancer
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| James Catto, MD
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| James Catto introduced the trial design of SunRISe-3, which aims to evaluate the efficacy and safety of TAR-200 plus cetrelimab or TAR-200 alone versus intravesical BCG in patients with BCG-naive high-risk non–muscle-invasive bladder cancer. SunRISe-3 is a phase 3 study involving 1,050 eligible patients who will be randomized to receive TAR-200 + cetrelimab, TAR-200, or BCG.
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| First Safety and Efficacy Results of the TAR-210 Erdafitinib Intravesical Delivery System in Patients with Non–Muscle Invasive Bladder Cancer with Select FGFR Alterations |
| Antoni Vilaseca, MD |
| Antoni Vilaseca presented the first safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer (NMIBC) harboring select FGFR alterations. TAR-210 demonstrated promising clinical activity, with an 82% recurrence-free rate in high-risk NMIBC patients (cohort 1) and an 87% complete response rate in intermediate-risk NMIBC patients (cohort 3). |
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| Efficacy of Intravesical Nadofaragene Firadenovec-Vncg for Patients with BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer: 36-Month Follow-up from a Phase 3 Trial |
| Colin Dinney, MD |
| Colin Dinney presented the 36-month follow-up results from a phase 3 trial evaluating the efficacy of intravesical nadofaragene firadenovec-vncg in patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). The study demonstrated that nadofaragene firadenovec-vncg administered once every 3 months led to a durable sustained complete response of 9.7 months, with approximately 25% of patients with BCG-unresponsive CIS ± Ta/T1 papillary disease remaining high-grade recurrence-free by 36 months. |
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| Validation of FGFR Screening by Uromonitor® and Therascreen in FFPE Tissue in Bladder Cancer in the Context of the Clinical-Pathological Real-World Registry Study "Bladder BRIDGister"
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| Thorsten Ecke
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| Thorsten Ecke presented findings from a study validating FGFR screening methods in bladder cancer within the Bladder BRIDGister real-world registry. The study analyzed 398 tissue samples from patients undergoing TURBT, using Uromonitor® and Therascreen assays to detect FGFR mutations. Results showed an 86% concordance between the two tests, with FGFR3 mutations S249C and R248C being the most frequently detected.
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Navigating Urothelial Carcinoma: From Innovative Diagnostics to Therapeutic Strategies
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| A Phase II Clinical Trial of Neoadjuvant Sasanlimab and Stereotactic Body Radiation Therapy as an in Situ Vaccine for Cisplatin Ineligible Muscle Invasive Bladder Cancer |
| Raj Satkunasivam, MD, MS |
| Raj Satkunasivam presented an update on a phase II clinical trial evaluating neoadjuvant sasanlimab plus stereotactic body radiation therapy (SBRT) as an in-situ vaccine for cisplatin ineligible MIBC at the EAU 2024 annual congress. The trial aims to assess the safety, feasibility, and efficacy of combining systemic ICI therapy with SBRT directed to the primary tumor as an in-situ vaccine to improve locoregional control and reduce the risk of distant recurrence in cisplatin-ineligible MIBC patients. |
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| Subsequent Therapies After Intravesical BCG in Patients with Bladder Cancer: Analysis of Real-World Treatment Patterns |
| Bolan Linghu, Ph.D. |
| Bolan Linghu presented findings on real-world treatment patterns of subsequent therapies after intravesical BCG in patients with bladder cancer at the EAU 2024 annual meeting. The retrospective study analyzed data from over 13,000 patients with non-muscle-invasive bladder cancer who received BCG treatment. Approximately 45.7% of patients experienced BCG failure, with intravesical chemotherapy being the most common subsequent treatment. The timing of subsequent therapy initiation varied, with most patients starting treatment within a year of BCG failure. |
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NMIBC: Benefits and Harms of Various Treatment Options
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| The International Bladder Cancer Group Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IBCG IR-NMIBC) Scoring System Predicts the Need for Intervention for Patients on Active Surveillance |
| Roberto Contieri, MD |
| Roberto Contieri presented findings from an analysis evaluating the International Bladder Cancer Group Intermediate-risk Non-muscle Invasive Bladder Cancer scoring system to predict the need for intervention among patients on active surveillance for low-grade NMIBC. The study, based on the Bladder Italian Active Surveillance (BIAS) registry, demonstrated that patients with more IBCG IR-NMIBC risk factors were more likely to undergo delayed TURBT compared to those with fewer risk factors. |
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| Does Audit, Feedback and Education Improve Quality Indicator Achievement and Reduce Early Recurrence Rates in TURBT Surgery for NMIBC? Results from the RESECT Cluster Randomised Trial |
| Kevin Gallagher, MBChB, Ph.D. |
| Kevin Gallagher presented findings from the RESECT cluster randomized trial, which investigated the impact of audit, feedback, and education on improving quality indicators and reducing early recurrence rates in transurethral resection of bladder tumor (TURBT) for non-muscle invasive bladder cancer (NMIBC). The study, involving 201 sites and 15,879 patients, found that the intervention group with feedback and education tools showed significant improvements in resection completeness and key tumor feature documentation. |
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| Challenging the Paradigm of BCG Unresponsive Bladder Cancer: Does Additional BCG Have an Effect? |
| Amanda Myers, MD |
| Amanda Myers presented findings from a single-center analysis evaluating the response rates to additional bacillus Calmette-Guerin (BCG) instillations in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Despite the emergence of novel approved agents, re-challenging patients with additional courses of BCG remains an option in select circumstances. |
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| Outpatient Laser Coagulation of Low-Grade Intermediate Risk Bladder Tumor Compared with TURBT, 12 Months and Long-Term Follow-up of a Noninferiority RCT |
| Gyrithe Lynghøj Pedersen, MD |
| Gyrithe Pedersen presented long-term results from a randomized controlled trial comparing outpatient laser coagulation to transurethral resection of bladder tumor (TURBT) for low-grade, intermediate-risk bladder tumors at EAU 2024. The study found that 12-month recurrence-free survival rates were comparable between the two treatments, with long-term recurrence-free survival also showing no significant difference. |
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| First Results of the Phase Ib-II BladderGATE Clinical Trial: Intravenous Atezolizumab + Intravesical Bacillus Calmette-Guérin (BCG) Upfront Combination in BCG-Naïve High Risk Non-Muscle Invasive Bladder Cancer Patients |
| Felix Guerrero-Ramos, MD, PhD, FEBU |
| Felix Guerrero-Ramos presented the phase Ib-II BladderGATE clinical trial's initial findings, assessing intravenous atezolizumab + intravesical BCG upfront combination in BCG-naïve, high-risk NMIBC patients. The study demonstrated the feasibility and safety of this combination, with a 2-year high-grade bladder recurrence-free survival rate of 83.2% and a low progression rate to muscle-invasive disease. Further evaluation will occur in the phase 3 ALBAN study (GETUG). |
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| Intravesical Administration of Durvalumab to Patients with High Risk Non-Muscle Invasive Bladder Cancer Who Experience BCG Failure. Final Results from a Phase II Study by the Hellenic GU Cancer Group |
| Charalampos Fragkoulis, MD, MSc |
| Charalampos Fragkoulis presented the final results of a phase II study evaluating intravesical durvalumab in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who experienced Bacillus Calmette-Guerin (BCG) failure. The study showed that intravesical durvalumab administration at 1,000 mg is feasible in this patient population with negligible toxicity. |
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