This series of video briefs features Dr. Neal Shore reporting from AUA 2025 in Las Vegas. Tune in for timely updates on innovatively delivered intravesical therapies for non–muscle invasive bladder cancer (NMIBC). Dr. Shore presents key findings from the SunRISe-1 trial, highlighting 1-year durability and patient-reported outcomes data in BCG-unresponsive high-risk NMIBC. He also covers the first results from cohort 4 of SunRISe-1, with a focus on papillary disease-only patients, along with the study design of the phase 3 MoonRISe-3 trial in patients with BCG-treated high-risk NMIBC and FGFR alterations. Each brief distills the clinical relevance of these studies and their potential impact on future NMIBC treatment strategies.
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First Results From Cohort 4 of the SunRISe-1 Trial
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Announcer:
Welcome to DataPulse from AUA 2025 on ReachMD. This activity, titled “First Results From Cohort 4 of the SunRISe-1 Trial” is provided by Prova Education.
Dr. Shore:
Hi, everybody. Neal Shore here in Las Vegas AUA 2025. Want to tell you about Cohort 4, which is the first time it's been presented as part of the SunRISe-1 trial. This is a BCG-unresponsive NMIBC patient population. Felix Guerrero-Ramos presented this. This was 52 patients with papillary disease only. Patients responded incredibly well to monotherapy TAR-200, which is a drug-releasing system of gemcitabine, a greater dwell time, as opposed to intravesical liquid delivery.
Bottom line was these patients had north of 80% with durable response, disease-free survival were the endpoints. There were essentially 98% survival, as you would expect in high-grade papillary. But what's interesting, we don't have any approved therapies in the BCG-unresponsive papillary only. We have it in CIS. These are really the most compelling responses I've seen so far in this NMIBC high-risk papillary-only group. So very compelling, very well tolerated, the TAR-200 and the bevy of the SunRISe platform, SunRISe-1 BCG unresponsive. I'm doing the SunRISe-3, which is the BCG-naïve high-risk NMIBC patients. There's the 2 and the 4, which looked at muscle invasive, and the 5, which is ongoing, looking at patients who have had exposure, experienced BCG.
What we note is, overall, this is an easy releasing system to insert, to remove, and the tolerability appears to be very consistent with any type of instrumentation of the urethra. This is really great for our patients with high-risk NMIBC. This particular paper that I'm referring to was in BCG-unresponsive papillary cohort only.
Great to speak with you. Neal Shore talking to you from Las Vegas AUA 2025. Thanks very much.
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Prova Education designs and executes continuing education founded on evidence-based medicine, clinical need, gap analysis, learner feedback, and more. Our mission is to serve as an inventive and relevant resource for clinical content and educational interventions across a broad spectrum of specialties. Prova Education's methodology demonstrates a commitment to continuing medical education and the innovative assessment of its effects. Our goal is clear—to develop and deliver the best education in the most impactful manner and to verify its results with progressive outcomes research.
Commercial Support
This activity is supported by an independent educational grantfrom Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC
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Related
Overview
This series of video briefs features Dr. Neal Shore reporting from AUA 2025 in Las Vegas. Tune in for timely updates on innovatively delivered intravesical therapies for non–muscle invasive bladder cancer (NMIBC). Dr. Shore presents key findings from the SunRISe-1 trial, highlighting 1-year durability and patient-reported outcomes data in BCG-unresponsive high-risk NMIBC. He also covers the first results from cohort 4 of SunRISe-1, with a focus on papillary disease-only patients, along with the study design of the phase 3 MoonRISe-3 trial in patients with BCG-treated high-risk NMIBC and FGFR alterations. Each brief distills the clinical relevance of these studies and their potential impact on future NMIBC treatment strategies.
Provider
Prova Education designs and executes continuing education founded on evidence-based medicine, clinical need, gap analysis, learner feedback, and more. Our mission is to serve as an inventive and relevant resource for clinical content and educational interventions across a broad spectrum of specialties. Prova Education's methodology demonstrates a commitment to continuing medical education and the innovative assessment of its effects. Our goal is clear—to develop and deliver the best education in the most impactful manner and to verify its results with progressive outcomes research.
Commercial Support
This activity is supported by an independent educational grantfrom Janssen Biotech, Inc., administered by Janssen Scientific Affairs, LLC
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