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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| Advances in Treatment Options for BCG Unresponsive CIS and Papillary Non-Muscle Invasive Bladder Cancer - QUILT 3.032 |
| Sam Chang, MD, MBA |
| Sam Chang joins Ashish Kamat to discuss the results of the QUILT study, which he presented at the GU ASCO 2022 annual meeting. QUILT 3.032 is an open-label, multicenter phase 3 study of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade non-muscle-invasive bladder cancer with CIS and papillary disease. |
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| Novel Immune Checkpoint Axis To Understand BCG Resistance and Improve Treatment in Non-muscle Invasive Bladder Cancer |
Amir Horowitz, Ph.D. and John Sfakianos, MD
John Sfakianos and Amir Horowitz join Ashish Kamat discussing a novel immune checkpoint axis in non-muscle-invasive bladder cancer, specifically looking at the HLA-E and NKG2A axis in non-muscle invasive bladder cancer, as it relates to Bacillus Calmette-Guerin (BCG) and BCG resistance. |
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| Phase II Trial for BCG Unresponsive Non-Muscle Invasive Bladder Cancer
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| Michael Woods, MD
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| Joining Alicia Morgans is Michael Woods, who is the leader of the Alliance Trial A031803, a phase II trial studying how well gemcitabine with pembrolizumab works in treating patients with non-muscle invasive bladder cancer (NMIBC) who are unresponsive to bacillus Calmette-Guérin (BCG).
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| Positive Efficacy and Safety, Phase 3 Results in Both CIS and Papillary Cohorts BCG-Unresponsive NMIBC After IL-15RαFc Superagonist N-803 (Anktiva) and BCG Infusion
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| Sam S. Chang, MD, MBA
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| Sam Chang reports the results of a phase 3 trial assessing IL-15RαFc superagonist N-803 (Anktiva) and BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Given the observed strong efficacy, favorable adverse event profile, and mode of administration, N-803 represents a significant advance in the treatment option compared to existing therapies for BCG unresponsive CIS and papillary NMIBC.
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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 expanding horizons in localized bladder cancer. Dr. Van Der Heijden highlights three presentations: “Cell-free DNA methylation as a predictive biomarker of response to neoadjuvant chemotherapy for patients with MIBC in SWOG S1314”, as well as, “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”, and “Final clinical results of the pivotal trial of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive CIS and papillary NMIBC”.
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| Final Clinical Results of The Pivotal Trial of IL-15R&[alpha]Fc Superagonist N-803 with BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) CIS and Papillary Cohorts
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| Karim Chamie, MD
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| In this presentation, Karim Chamie presents the results of N-803 in combination with BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This is a disease space in which there is a significant unmet need. These results show that the efficacy and safety profile of N-803+BCG exceeds other available intravesical and systemic options.
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| BOND3: A Phase 3, Single-Arm Study of CG0070 in Subjects With Non-Muscle Invasive Bladder Cancer Unresponsive to BCG
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| Edward Uchio, MD
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| The 2022 GU ASCO Annual meeting included a urothelial carcinoma trials in progress session featuring BOND3, a phase 3, single-arm study of CG0070 in subjects with non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG, presented by Edward Uchio. CG0070 is a serotype 5 adenovirus engineered to express GM-CSF and replicate in cells with mutated or deficient RB.
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| Final Clinical Results of Pivotal Trial of IL-15R&[alpha]Fc Superagonist N-803 with BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) CIS and Papillary Cohorts |
| Karim Chamie, MD |
| Karim Chamie presents the results of N-803 in combination with BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). These results show that the efficacy and safety profile of N-803+BCG exceeds other available intravesical and systemic options. |
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