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PEER-TO-PEER CLINICAL CONVERSATIONS |
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Emerging Neoadjuvant Combinations for Muscle-Invasive Bladder Cancer
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Mamta Parikh, MD, MS
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| Mamta Parikh explores emerging combination therapies for muscle-invasive bladder cancer. Dr. Parikh details several ongoing trials evaluating various treatment combinations, including checkpoint inhibitors with chemotherapy, antibody-drug conjugates, and intravesical therapies in both cisplatin-eligible and ineligible patients.
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| NIAGARA Trial: Chemo Plus Durvalumab Improves Survival in Muscle-Invasive Bladder Cancer |
| Thomas Powles, MBBS, MRCP, MD |
| Shilpa Gupta interviews Thomas Powles about the NIAGARA study, which examines perioperative chemoimmunotherapy in muscle-invasive bladder cancer. Dr. Powles discusses the trial's design, combining durvalumab with chemotherapy before and after cystectomy, highlighting its significant improvements in event-free and overall survival. |
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| SunRISe-2 Trial: TAR-200 and Cetrelimab vs. Chemoradiotherapy for Muscle-Invasive Bladder Cancer |
| Stephen Williams, MD, MS, FACS |
| Sam Chang and Stephen Williams discuss the ongoing SunRISe-2 trial, a phase three study targeting muscle-invasive bladder cancer (MIBC). Dr. Williams details the trial's innovative approach using TAR-200, a device for sustained gemcitabine release directly into the bladder, combined with cetrelimab, a PD-1 antibody. |
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| Emerging Therapeutics: Combination Therapy in Neoadjuvant Setting |
| Mamta Parikh, MD, MS |
| Mamta Parikh presents on emerging neoadjuvant combination therapies for muscle-invasive bladder cancer (MIBC). For cisplatin-eligible patients, the NIAGARA trial demonstrated improved outcomes with durvalumab combined with gemcitabine-cisplatin, showing better event-free survival and higher pathological complete response rates compared to standard chemotherapy. Additional studies, including EV-304 and ENERGIZE, are exploring similar combinations with immune checkpoint inhibitors and antibody-drug conjugates. |
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| Exploratory Analysis of Post-Treatment Outcomes in Patients with BCG-Unresponsive High-risk, NMIBC Who Experienced Non-Response to Pembrolizumab Monotherapy in KEYNOTE-057
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| Roger Li, MD
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| Roger Li presents an exploratory analysis of outcomes in patients with BCG-unresponsive, high-risk NMIBC who did not respond to pembrolizumab monotherapy in the KEYNOTE-057 trial. Findings suggested similar progression-free, metastasis-free, and overall survival rates across groups undergoing early, delayed, or no radical cystectomy following treatment failure.
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| Emerging Perioperative Systemic Therapy |
| Jacqueline Brown, MD |
| Jacqueline Brown highlights advancements in perioperative systemic therapies for MIBC. Standard treatment includes neoadjuvant chemotherapy followed by radical cystectomy, with adjuvant nivolumab recommended for high-risk residual disease post-surgery. Recent trials, such as NIAGARA, showed improved outcomes by combining gemcitabine + cisplatin with durvalumab, while novel agents like enfortumab vedotin, disitamab vedotin, and TAR-200 are demonstrating promising results in the perioperative setting. Biomarkers like ctDNA are emerging as tools to refine treatment strategies, aiming to balance efficacy and safety while minimizing overtreatment. |
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| Integrating Novel Therapeutics with Trimodal Therapy (TMT) |
| Gopakumar Iyer, MD |
| Gopakumar Iyer discussed integrating novel therapeutics with trimodal therapy (TMT) for muscle-invasive bladder cancer. TMT, combining chemoradiotherapy with bladder preservation, is evolving with the inclusion of immune checkpoint inhibitors (ICIs) and antibody-drug conjugates (ADCs). Prominent trials, such as KEYNOTE-992 and SWOG S1806, explore the efficacy of ICIs like pembrolizumab and atezolizumab in enhancing TMT outcomes. |
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| ctDNA Clearance with Neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin for Cisplatin-Ineligible MIBC from the Safety Run-in Cohort of the Phase 3 VOLGA Trial
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| Alexandra Drakaki, MD
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| Alexandra Drakaki presents exploratory findings from the phase 3 VOLGA trial's safety run-in cohort, examining ctDNA clearance in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) treated with neoadjuvant durvalumab, tremelimumab, and enfortumab vedotin. The study revealed a significant association between ctDNA clearance during therapy and favorable outcomes, including pathologic response and longer event-free survival. Among patients with ctDNA clearance, 83% showed either complete or downstaged responses at radical cystectomy.
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| Study EV-103: Neoadjuvant Treatment with Enfortumab Vedotin Monotherapy in Cisplatin-Ineligible Patients with Muscle-Invasive Bladder Cancer (MIBC) 2-Year Event-Free Survival and Safety Data for Cohort H
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| Peter O'Donnell, MD
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| Peter O'Donnell presents two-year data from Cohort H of the EV-103 trial, evaluating enfortumab vedotin monotherapy as neoadjuvant treatment for cisplatin-ineligible MIBC patients. The study reported a 62% event-free survival rate at 24 months, with a pathological complete response rate of 36.4% and a manageable safety profile. These findings support further trials exploring enfortumab vedotin in the neoadjuvant setting for MIBC.
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