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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| Novel CD40 Antibody Treatment for BCG-Unresponsive Bladder Cancer |
| Bernard H. Bochner, MD, FACS |
| Sam Chang and Bernard Bochner discuss a novel antibody treatment targeting the CD40 receptor for non-muscle invasive bladder cancer resistant to BCG therapy. Dr. Bochner presents findings from a phase one study showing promising results with minimal toxicity. |
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| Treatment Options Expand for BCG Unresponsive Bladder Cancer |
| 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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BCG Unresponsive Bladder Cancer in 2024
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Ashish Kamat, MD, MBBS
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| Zachary Klaassen and Ashish Kamat explore the evolving landscape of BCG-unresponsive bladder cancer treatment. Dr. Kamat traces the development of treatment options from the establishment of BCG-unresponsive disease criteria to the current array of approved and emerging therapies, including pembrolizumab, nadofaragene, and newer agents like TAR-200 and cretostimogene.
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| A New Horizon in BCG Unresponsive Non-Muscle Invasive Bladder Cancer: Anktiva (N-803) + BCG |
| Zachary Klaassen, MD, MSc |
| The combination of Anktiva (N-803) and BCG has emerged as a promising treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), demonstrating high complete response rates and durable outcomes in the QUILT-3.032 trial, leading to FDA approval in 2024. N-803 enhances immune response via IL-15 superagonist activity, improving survival metrics and addressing the unmet needs in BCG-refractory NMIBC. |
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| Topline Results from BOND-003: A Phase-3 Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk BCG-Unresponsive NMIBC with CIS |
| Mark Tyson, II MD, MPH |
| The phase III BOND-003 trial demonstrated that intravesical cretostimogene grenadenorepvec, an oncolytic immunotherapy, achieved a 74.5% overall complete response rate in high-risk BCG-unresponsive NMIBC with CIS, with durable responses maintained in 64% and 57% of responders at 12 and 24 months, respectively. The therapy was well-tolerated, with no grade ≥3 treatment-related adverse events or discontinuations, and fits seamlessly into clinic workflows. |
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| Elucidating the Response Rates to Additional BCG: Implications for Clinical Trial Design
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| Amanda Myers, MD
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| Amanda Myers presented data at IBCN 2024 evaluating the response rates to additional BCG in BCG-exposed and BCG-unresponsive NMIBC patients. The study demonstrated high complete response rates of 79% for BCG-exposed and 75% for BCG-unresponsive patients, with median durations of response of 169 and 83 months, respectively. These findings highlight the importance of using BCG as a control arm in clinical trials for BCG-exposed populations and provide valuable data to inform trial design and power calculations.
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| Challenging the Paradigm of BCG Unresponsive Bladder Cancer: Does Additional BCG Have an Effect? |
| Amanda Myers, MD |
| Amanda Myers presented a study at EAU 2024 evaluating the efficacy of additional BCG in patients with BCG-unresponsive NMIBC. The analysis found that 75% of patients were disease-free after receiving rescue BCG, with a median disease-free survival of 75 months. The results challenge the current guidelines that discourage further BCG therapy, suggesting that additional BCG may offer durable benefits for selected patients and calling for randomized controlled trials to further explore this approach. |
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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 36-month follow-up results from a phase 3 trial assessing the efficacy of intravesical nadofaragene firadenovec-vncg for BCG-unresponsive non-muscle-invasive bladder cancer. The treatment showed a durable complete response, with 25% of CIS ± Ta/T1 patients and 31% of high-grade Ta/T1 patients remaining recurrence-free at 36 months. The median duration of complete response was 9.7 months, and there were no new safety concerns identified. Nadofaragene firadenovec-vncg remains a novel, safe, and effective option for these patients. |
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