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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Trial in Progress: Phase 3 MoonRISe-3 Study
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Announcer:
Welcome to DataPulse from AUA 2025 on ReachMD. This activity, titled “Trial in Progress: Phase 3 MoonRISe-3 Study” is provided by Prova Education.
Dr. Shore:
Hi, everyone. I'm Neal Shore. I'm the Medical Director of START Carolina Urologic Research Center in Myrtle Beach, South Carolina.
I want to talk to you about the data that was presented at AUA this year, some further follow-up on the cohort of SunRISe-1, a trial that looked at BCG-unresponsive patients with NMIBC. And this particular cohort looked at over 80 patients. It was a multi-cohort study, but in this cohort, these were the patients who received just the drug-releasing system of TAR-200, which releases gemcitabine. The releasing system is provided every 3 weeks.
What was really fascinating and tremendous in a plenary presentation here at AUA was that the complete response rate was north of 80%. This is the highest complete response rate we've seen in all other approved therapies in BCG unresponsiveness, 12-month durability and response was 52%. And this is really a remarkable achievement.
I think this is going to be a really significant addition to our BCG-unresponsive armamentarium. We have other therapies for our BCG-unresponsive patients who have CIS, high-grade Ta and T1, they can ultimately get radical cystectomy. In the US, we have other intravesical therapies. We have checkpoint inhibitor systemic therapies, all not always available in the US. I think what's notable about the TAR-200 is it's an off-the-shelf product and may be very appealing to urologists, no matter where they practice.
And I'm Neal Shore. I'm here at AUA 2025 in Las Vegas. It was great to speak with you.
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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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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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