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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| CORE-008 Cohort B Investigates Cretostimogene Grenadenorepvec for BCG-Exposed High-Risk NMIBC |
| Trinity Bivalacqua, MD, PhD |
| Zachary Klaassen speaks with Trinity Bivalacqua about CORE-008 Cohort B, investigating cretostimogene grenadenorepvec in BCG-exposed high-risk non-muscle invasive bladder cancer. |
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| 24-Month Follow-Up Data from Phase 3 BOND-003 Cohort C Trial |
| Mark Tyson II, MD, MPH |
| Zachary Klaassen speaks with Mark Tyson about 24-month follow-up data from BOND-003 Cohort C evaluating cretostimogene grenadenorepvec in BCG-unresponsive CIS patients. |
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Highlights from the 2025 Society of Urologic Oncology Annual Meeting |
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| Physician Experiences with TAR-200 in High-risk Non-muscle Invasive Bladder Cancer: A Qualitative Study of the SunRISe Trial Investigators |
| Joshua Meeks, MD, PhD |
| This qualitative SUO 2025 study gathered experiences from SunRISe trial investigators using TAR-200 (Gem-iDRS) in high-risk NMIBC, finding that insertion and removal were quick, straightforward, and feasible across community and urban clinical settings. Providers reported that Gem-iDRS was well tolerated with mostly mild, local urinary symptoms and offered practical advantages over conventional intravesical therapies, including fewer visits, continuous drug delivery, and reduced staff burden. |
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| Intravesical T3011, an IL-12/Anti-PD-1 Armed Oncolytic HSV-1, in BCG-Unresponsive High-Risk NMIBC: A Phase I/IIa Trial
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| Dingwei Ye, MD, PhD
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| The Phase I/IIa trial of intravesical T3011—an IL-12 and anti–PD-1–armed oncolytic HSV-1—shows promising early efficacy in BCG-unresponsive high-risk NMIBC, with complete response rates up to 100% in CIS at the higher dose and strong recurrence-free survival in Ta/T1 disease. Treatment was generally well tolerated, with mostly grade 1 urinary symptoms and no grade 4–5 or serious treatment-related adverse events.
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| Durable 24 Month Outcomes from BOND-003 Cohort C: Phase 3 Study of Intravesical Cretostimogene Grenadenorepvec for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with CIS |
| Mark Tyson, MD, MPH |
| The BOND-003 Phase 3 Cohort C trial shows that intravesical cretostimogene grenadenorepvec achieves high and durable complete response rates in high-risk BCG-unresponsive NMIBC with CIS, with a 75.5% overall CR and ~42% maintained at 24 months. Most responders remained disease-free long-term, with 96% avoiding progression to muscle-invasive disease and 84% avoiding cystectomy, all with an excellent safety profile and no grade ≥3 treatment-related toxicities. |
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| Trials in Progress - CORE-008 Cohort B: Evaluating Intravesical Cretostimogene Grenadenorepvec in Patients with High Risk, BCG-Exposed NMIBC |
| Trinity Bivalacqua, MD, PhD |
| CORE-008 Cohort B is a phase 2 trial evaluating intravesical cretostimogene grenadenorepvec in patients with high-risk, BCG-exposed NMIBC—a population that falls outside strict FDA “BCG-unresponsive” criteria and faces limited treatment options. The study uses cretostimogene plus DDM across an induction and long-term maintenance schedule, with primary endpoints of complete response and high-grade event-free survival, supported by rigorous cystoscopic and pathologic assessments. |
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| Feasibility and Safety of Intravesical Therapy with Autologous Tumor Infiltrating Lymphocytes in BCG Exposed NMIBC: Results from a Phase I Clinical Trial |
| David Nusbaum, MD |
| A phase I trial presented at SUO 2025 demonstrated that intravesical therapy using autologous tumor-infiltrating lymphocytes (TILs) is feasible and safe for patients with BCG-exposed high-risk NMIBC, with all nine participants successfully undergoing TIL harvest, expansion, and instillation and experiencing only grade 1–2 adverse events. The 3-month complete response rate was 44%, and two patients have maintained durable responses with no progression to muscle-invasive disease. |
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| Preoperative ctDNA Predicts Upstaging and Recurrence in High-Risk NMIBC Undergoing Radical Cystectomy |
| Reuben Ben-David, MD |
| Reuben Ben-David presented a bi-center analysis showing that detectable preoperative ctDNA in high-risk NMIBC patients undergoing radical cystectomy strongly predicts pathologic upstaging, nodal involvement, and significantly worse recurrence-free survival. Patients with detectable ctDNA had far higher rates of ≥pT2 and pN+ disease and a markedly poorer 6- and 12-month RFS compared to ctDNA-negative patients. |
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