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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| The Role of Gene Therapy in Enhancing Bladder Cancer Patient Outcomes |
| Mark Tyson II, MD, MPH |
| Neal Shore and Mark Tyson discuss advances in non-muscle invasive bladder cancer treatments, particularly for BCG unresponsive patients. They delve into the approval and data on nadofaragene firadenovec, a novel intravesical gene therapy, highlighting its efficacy and patient-friendly administration schedule. |
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| Genomic Heterogeneity as a Barrier to Precision Oncology in Urothelial Cancer |
| Timothy Clinton, MD |
| Sam Chang introduces Timothy Clinton to discuss his groundbreaking work on the genomic characteristics of urothelial carcinoma. Dr. Clinton's research explores the genomic heterogeneity within bladder cancer, specifically focusing on the differences between primary and metastatic patients. |
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BCG Shortage: What’s on the Horizon to Replace?
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Joshua Meeks, MD, Ph.D.
Zach Klaassen and Joshua Meeks discuss the ongoing BCG shortage impacting bladder cancer treatment, tracing its origins back to production issues in 2012 and guideline changes in 2016 that increased BCG demand. They highlight the shift towards using gemcitabine-docetaxel as both a salvage and primary treatment for high-risk bladder cancer due to its effectiveness and availability.
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| Heterogeneity of BCG-Unresponsive Bladder Cancer Clinical Trials Limits Patients' Access to Novel Therapeutics - Beyond the Abstract |
| Debasish Sundi, MD |
| Bladder cancer clinical trial design for BCG unresponsive disease often excludes eligible patients due to strict criteria, hindering access to novel therapeutics. Despite the increasing incidence of bladder cancer and rapid therapeutic innovations, many trials have limited generalizability and fail to reflect real-world patient populations. Advocacy for more inclusive and pragmatic trial designs is essential to ensure that patients with bladder cancer have access to effective treatments in clinical practice. |
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| BCG Shortage: What’s on the Horizon to Replace? |
| Joshua Meeks, MD, Ph.D. |
| Joshua Meeks addresses the BCG shortage in bladder cancer treatment, presenting alternative options including gemcitabine + docetaxel and novel therapies like TAR-200 and cretostimogene grenadenorepvec. Precision oncology, exemplified by TAR-210, emerges as a promising avenue for bladder cancer treatment beyond BCG. |
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| TAR-210 Erdafitinib Intravesical Delivery System in Patients with Non–Muscle Invasive Bladder Cancer with Select FGFR Alterations: First Safety and Efficacy Results
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| Antoni Vilaseca, MD
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| Antoni Vilaseca presents the initial findings on TAR-210, an intravesical erdafitinib delivery system for non-muscle-invasive bladder cancer (NMIBC) with FGFR alterations. Results show promising clinical activity, with 82% BCG-experienced high-risk NMIBC patients and 87% intermediate-risk NMIBC patients achieving positive outcomes. TAR-210 demonstrates minimal systemic exposure and tolerable adverse events, suggesting the potential for further phase 3 studies in FGFR-altered localized bladder cancer.
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| SunRISe-1: TAR-200 Monotherapy in Patients With BCG-Unresponsive High-Risk Non–Muscle Invasive Bladder Cancer (HR NMIBC)
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| Andrea Necchi, MD
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| Andrea Necchi presents results from SunRISe-1 on TAR-200 monotherapy in BCG-unresponsive high-risk non-muscle-invasive bladder cancer. The study shows a promising centrally-assessed complete response rate of 77%, with 91% of responses ongoing and some lasting over 12 months. TAR-200 demonstrates tolerable adverse events, suggesting its potential as a treatment option in this patient population.
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| The Current Treatment Landscape of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: N-803 and Viral/Bacterial-Based Therapies
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| Rashid Sayyid, MD, MSc, and Zachary Klaassen, MD, MSc
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| The standard treatment for high-risk non-muscle invasive bladder cancer is intravesical BCG therapy, but up to 50% of patients become BCG-unresponsive, necessitating alternative options due to the risks associated with radical cystectomy. Novel therapies for BCG-unresponsive NMIBC include Nogapendekin alfa-inbakicept (NAI), viral/bacterial-based therapies like nadofaragene firadenovec, and Cretostimogene Grenadenorepvec.
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| Efficacy of Intravesical Nadofaragene Firadenovec-vcng for Patients with Bacillus Calmette-Guerin-Unresponsive Carcinoma in Situ of the Bladder: 36-Month Follow-Up from a Phase 3 Trial |
| Stephen Boorjian, MD |
| The 36-month follow-up of the phase 3 trial on intravesical nadofaragene firadenovec for BCG-unresponsive bladder cancer showed sustained efficacy, with approximately 25% of patients maintaining a complete response. Cystectomy-free survival at 36 months was 53.8%, and overall survival at 3 years was 90.4%, indicating promising long-term outcomes with this novel treatment option. |
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