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PEER-TO-PEER CLINICAL CONVERSATIONS |
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Timing of Radical Cystectomy in BCG-Unresponsive Disease
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Alicia Morgans, MD, MPH and Patrick J. Hensley, MD
Alicia Morgans is joined by Patrick Hensley in a discussion on the ability to triage patients for a timely cystectomy who have BCG-unresponsive disease. There are clearly defined criteria for selecting very high-risk patients for early upfront cystectomy before trialing any intravesical therapy.
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Conundrums in Bacillus Calmette Guerin (BCG)-Unresponsive Nonmuscle Invasive Bladder Cancer Trials
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Roger Li, MD
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| Joining Ashish Kamat is Roger Li to dive into all things relating to BCG-unresponsive bladder cancer. Dr. Li shares what is known about BCG-unresponsive disease, some of the conundrums that clinicians and the FDA are challenged by when evaluating and designing clinical trials in this area, and answers a series of questions from Dr. Kamat covering many topics in BCG-unresponsive clinical trials.
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Underlying Mechanism of Action of N-803 + BCG Inducing Durable Complete Response in BCG-Unresponsive NMIBC
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Patrick Soon-Shiong, MD
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| Patrick Soon-Shiong joins Ashish Kamat in a discussion on the mechanism of action of N-803 (AnktivaTM) + BCG Inducing Durable Complete Response in BCG-Unresponsive NMIBC. N-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein.
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| Final Clinical Results of the Pivotal Trial of IL-15RαFc Superagonist N-803 With BCG in BCG-Unresponsive CIS and Papillary Nonmuscle-Invasive Bladder Cancer
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| Karim Chamie, MD
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| BCG therapy in non-muscle invasive bladder cancer induces cytokine release that activates NK and T immune cells and results in bladder cancer cell killing and immune memory against further tumor growth. It has been hypothesized that the IL-15 superagonist N-803 could boost the immune response to BCG, thus augmenting patient responses to BCG therapy and limiting the need for cystectomy in this disease context. Karim Chamie presented results from the QUILT 3032 phase 2/3 study using the IL-15 superagonist N-803 in combination with BCG in previously BCG-unresponsive bladder cancer.
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| BCG-Unresponsive Bladder Cancer
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| Roger Li, MD
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| The 2022 Annual Meeting of the American Urological Association was host to a discussion section led by Dr. Roger Li regarding BCG unresponsive bladder cancer. Dr. Li highlighted the newest (Jan 2020) FDA-approved agent in this disease space: Pembrolizumab based on results from the pivotal Keynote-057 trial. Keynote-057 was a phase two clinical trial of 102 patients (96 in efficacy cohort). 64% of patients had CIS alone. He also discusses unpublished results from a recent meta-analysis performed by his team at Moffitt of all BCG unresponsive clinical trials.
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| Timing of Radical Cystectomy in BCG-Unresponsive Disease
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| Patrick Hensley, MD
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| The 2022 Annual Meeting of the American Urological Association (AUA) was host to The International Bladder Cancer Group (IBCG) AUA Bladder Cancer Forum which featured a presentation by Patrick Hensley who was tasked with discussing the timing of radical cystectomy in BCG-unresponsive patients. Dr. Hensley began his presentation by highlighting the current limitations in clinical staging accuracy.
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| State-of-the-Art Lecture: BCG-Unresponsive Disease
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| Seth Lerner, MD
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| The 2022 Annual Meeting of the American Urological Association (AUA) was host to The International Bladder Cancer Group (IBCG) AUA Bladder Cancer Forum which featured a State-of-the-Art lecture by Dr. Seth Lerner regarding the current state of BCG-unresponsive disease.
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| Novel Intravesical Bacterial Immunotherapy Induces the Rejection of BCG-Unresponsive Established Bladder Tumors - Beyond the Abstract
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| Eduardo Moreo and Nacho Aguiló
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| Intravesical BCG is the treatment of choice for intermediate and high-risk non-muscle invasive bladder cancer (NMIBC), but relapses or resistances appear in approximately 50 % of patients receiving this treatment. Currently, there are limited options for BCG-unresponsive disease besides radical cystectomy, a life-changing intervention, so there is an unmet clinical need for a large population of patients.
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| Expanding Horizons in Localized Bladder Cancer - Discussion
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| Michiel Van Der Heijden, MD, Ph.D.
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| Michiel Van Der Heijden discusses “Cell-free DNA methylation as a predictive biomarker of response to neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer in SWOG S1314” by Thomas Flaig, “TRUCE-02: An open label, single-arm, phase II study of tislelizumab combined with nab-paclitaxel for high-risk non-muscle-invasive urothelial bladder carcinoma” by Zesheng An, and “Final clinical results of pivotal trial of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive CIS and papillary NMIBC” by Karim Chamie.
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