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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| BCG Shortage: What’s on the Horizon to Replace? |
Joshua Meeks, MD, PhD
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. |
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Novel Bladder Cancer Treatment: Mechanisms, Clinical Findings, and Implications
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Patrick Soon-Shiong, MD
Ashish Kamat and Patrick Soon-Shiong explore the clinical development and FDA approval of Anktiva for bladder cancer. Dr. Soon-Shiong outlines the journey from initial studies in BCG-naive and BCG-unresponsive patients to approval.
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Phase 2 Trial: Chemotherapy Plus Immunotherapy Facilitates Bladder Sparing in Muscle-Invasive Bladder Cancer
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Matthew Galsky, MD
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| Ashish Kamat and Matthew Galsky discuss a phase 2 trial on organ sparing for muscle-invasive bladder cancer, published in Nature Medicine. Dr. Galsky highlights the trial's focus on systemic therapy as an alternative to cystectomy, noting its potential for curative outcomes.
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| A New Horizon in BCG Unresponsive NMIBC: Anktiva (N-803) + BCG |
| Zachary Klaassen, MD, MSc |
| The QUILT-3.032 trial demonstrated that the combination of N-803 with BCG significantly improves outcomes for patients with BCG-unresponsive NMIBC, leading to FDA approval in April 2024. The therapy showed high complete response rates and durability, with a median response duration of 26.6 months and excellent progression-free survival. Efforts to address global BCG shortages include a partnership with Serum Institute of India, while the QUILT-2.005 trial explores N-803 + BCG in BCG-naïve NMIBC with promising early results. |
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| BCG Shortage: What’s on the Horizon to Replace? |
| Joshua J Meeks, MD, PhD |
| Joshua Meeks discussed strategies to address the BCG shortage for NMIBC. Alternatives like gemcitabine + docetaxel have shown promising recurrence-free survival rates and may become a standard of care, though they lack FDA approval and widespread availability. Emerging approaches include novel BCG strains, immune checkpoint inhibitors, drug delivery devices like TAR-200, and precision therapies targeting molecular profiles, potentially reducing reliance on BCG. |
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| BCG Shortage – An End in Sight? |
| Danica May, MD |
| Danica May discusses the ongoing BCG shortage and treatment options for high-risk NMIBC. With Merck as the sole U.S. producer following the closure of Sanofi Pasteur's plant, BCG production has been ramping up, though shortages persist. Dr. May emphasized the need for alternative treatments like gemcitabine, docetaxel, and checkpoint inhibitors, as well as clinical trials assessing new approaches, including immune checkpoint inhibitors and novel drug delivery systems, which may provide more options in the near future. |
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| QUILT-2.005: A Comparison of Intravesical BCG in Combination with the IL-15 Superagonist N-803 to BCG Alone in Patients with BCG-Naïve NMIBC |
| Sandeep Reddy, MD |
| Sandeep Reddy presented the QUILT-2.005 trial, a phase IIb study comparing intravesical BCG combined with IL-15 superagonist N-803 (ANKTIVA®) to BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC). The trial aims to address the high recurrence rate (~40%) seen with BCG monotherapy. N-803 enhances immune responses by activating natural killer cells and T-cells, promoting durable complete remissions, particularly in combination with BCG. |
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| The Value of mpMRI to Assist in Decision-Making in Muscle-Invasive Bladder Cancer
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| Andrea Necchi, MD
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| Andrea Necchi discusses the role of multi-parametric MRI in decision-making for muscle-invasive bladder cancer. He highlights advancements in imaging, such as the VI-RADS scoring system, and the emerging nacVI-RADS system, which helps predict treatment responses and guide bladder-sparing strategies. Dr. Necchi emphasizes the need for improved imaging and biomarker models to personalize treatment while also addressing uncertainties about managing residual disease and defining complete responses for future bladder-sparing trials.
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Bladder Sparing Options for Muscle-Invasive Bladder Cancer - Beyond the Abstract
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| Ekaterina Laukhtina, MD |
| Bladder-sparing treatments for muscle-invasive bladder cancer (MIBC) are gaining attention as alternatives to radical cystectomy (RC), driven by the desire to balance survival outcomes with improved quality of life. Trimodal therapy, which combines maximal transurethral resection, radiotherapy, and chemotherapy, has shown comparable oncological outcomes to RC for carefully selected patients, especially those who are unfit for surgery or wish to avoid it. |
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| Perioperative Sacituzumab Govitecan Alone or in Combination with Pembrolizumab for Patients with Muscle-Invasive Urothelial Bladder Cancer: SURE-01/02 Interim Results |
| Antonio Cigliola, MD |
| Antonio Cigliola presents interim results from the SURE-01/02 trials, evaluating perioperative sacituzumab govitecan alone or with pembrolizumab in patients with muscle-invasive urothelial bladder cancer. The SURE-01 trial showed a promising pathologic complete response and an ypT≤1N0 response rate of 45%, though safety concerns led to protocol amendments, including dose reductions and changes in prophylactic measures for neutropenia. |
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