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Highlights from The 2025 Western Section AUA Annual Meeting |
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Re-Induction Nadofaragene in BCG-Unresponsive NMIBC: Real-World Multicenter Experience
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Bogdana Schmidt, MD, MPH
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| Bogdana Schmidt joins Ashish Kamat to discuss real-world experience with re-induction of nadofaragene firadenovec in BCG-unresponsive NMIBC. Across multiple centers, re-induction showed meaningful activity—particularly in papillary-only disease—and appeared safe, with low progression signals over early follow-up.
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| Final Results from BOND-003 Cohort C: A Phase 3, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for High Risk BCG Unresponsive NMIBC with CIS |
| Mark Tyson II, MD, MPH |
| BOND-003 Cohort C showed that intravesical cretostimogene achieved a 75.5% complete response rate in high-risk BCG-unresponsive NMIBC with CIS, with durable benefit — ~42% of patients still in complete response at 24 months and median DOR not yet reached. Most patients avoided progression and cystectomy, and treatment was very well-tolerated with no grade ≥3 related toxicities. These results support cretostimogene as a promising, bladder-sparing option in a population with very limited alternatives. |
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| First Results from BOND-003 Cohort P: A Multi-National, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for Treatment of High Risk, Papillary Only, BCG Unresponsive NMIBC |
| Mark Tyson II, MD, MPH |
| Early Cohort P data show that intravesical cretostimogene in high-risk BCG-unresponsive papillary-only NMIBC achieved ~90% high-grade recurrence-free survival at both 3 and 9 months in the first 24 patients evaluated. Treatment was well-tolerated with no serious treatment-related adverse events. These preliminary results suggest cretostimogene may offer a promising bladder-sparing option for a population with very limited alternatives, pending longer-term follow-up. |
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| Comparative Effectiveness of Intravesical Gemcitabine versus Sequential Gemcitabine and Docetaxel for High-Risk NMIBC
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| Mark Tyson II, MD, MPH
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| In this multicenter real-world study of 296 high-risk NMIBC patients, adding docetaxel to gemcitabine did not improve high-grade recurrence-free survival compared with gemcitabine alone — including in BCG-unresponsive subsets. Safety was similar between regimens, with mostly low-grade AEs. Prospective randomized trials are needed to determine if docetaxel provides meaningful incremental benefit.
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| Re-Induction with Nadofaragene Firadenovec for BCG-Unresponsive NMIBC: Real-World Data from a Multicenter Cohort |
| Bogdana Schmidt, MD, MPH |
| Re-induction with nadofaragene firadenovec in this small real-world multicenter cohort (n=17) of BCG-unresponsive NMIBC showed a 38% CR rate in CIS patients and 75% short-term disease-free rate in papillary-only disease, with a 53% 6-month high-grade RFS. Cystectomy-free survival (94%) and OS (100%) were high, and progression was rare. These early data suggest that re-induction may be reasonable in selected patients who have not progressed at 3 months, but longer follow-up and larger cohorts are needed. |
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| Updates to the CORE-008 Trial Protocol: A Phase 2 Multi-Arm, Multi-Cohort Study to Evaluate Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk NMIBC |
| Siamak Daneshmand, MD |
| CORE-008 is a phase 2 multi-arm study evaluating intravesical cretostimogene in high-risk NMIBC across BCG-naive, BCG-exposed, and BCG-unresponsive cohorts, including a combination arm with gemcitabine. Treatment involves induction plus maintenance through 36 months, and re-induction is allowed. Primary endpoints are CR (CIS) and high-grade event-free survival (papillary-only), and enrollment is actively ongoing, with CIS arms nearly complete. |
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| Real-World Utilization of Nadofaragene Firadenovec in Patients with BCG-Unresponsive NMIBC |
| Laura E. Davis, MD
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| In this real-world cohort of 101 BCG-unresponsive NMIBC patients treated with Adstiladrin, 86% did not require any additional therapy afterward, suggesting meaningful treatment durability outside of trials. TURBT was the most common retreatment when needed, but patterns were heterogeneous and occurred in a minority. Overall, these findings support Adstiladrin as a useful option in this space, with long-term management strategies still evolving.
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| Impact of Tumor Burden or Focality on Duration of Response to Treatment with UGN-102 in Recurrent Low-Grade Intermediate-Risk NMIBC |
| Chinedu Mmeje, MD |
| In this phase 3 ENVISION analysis, UGN-102 showed strong and durable activity in recurrent low-grade intermediate-risk NMIBC, with ~80% complete response at 3 months and ~80% of responders still disease-free at 18 months. Importantly, outcomes did not significantly differ whether tumors were ≤3 cm vs >3 cm or solitary vs multifocal. This suggests UGN-102 efficacy appears consistent across different baseline tumor burdens and focalities. |
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| Streamlined, Patient-Centric Design of the Cretostimogene Grenadenorepvec Expanded Access Program in Patients with NMIBC Unresponsive to BCG |
| Anne Schuckman, MD |
| This expanded access program offers cretostimogene to real-world BCG-unresponsive NMIBC patients who may be medically unfit for cystectomy or ineligible for standard trials. The protocol is intentionally flexible and mirrors routine NMIBC follow-up, with induction + maintenance dosing and the option for re-induction. Co-primary endpoints are safety and complete response, aiming to broaden access to a promising bladder-sparing gene therapy. |
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