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.
advertisement
SunRISe-1: 1-Year Durability and Patient-Reported Outcomes Results
Share
Save
Restart
Resume
Announcer:
Welcome to DataPulse from AUA 2025 on ReachMD. This activity, titled “SunRISe-1: 1-Year Durability and Patient-Reported Outcomes Results” is provided by Prova Education.
Dr. Shore:
Hi, everyone. Neal Shore here in Las Vegas AUA 2025. Want to tell you about a trial that’s in progress that I presented today. I'm at one of the sites on the steering committee. This is for BCG-experienced or patients who are unresponsive, with high-risk NMIBC, and particularly, we're really just looking at patients with papillary or T1 disease. And what we're targeting are patients who have the FGFR3 alteration, and they can be enrolled whether they have a tissue-based alteration, or a urine-based alteration. And this is really improving the era of precision-based care.
We've known already that patients with FGFR alterations, we have an approved oral version of a drug called erdafitinib, approved back in 2017 for second-/third-line metastatic urothelial cancer patients. There's actually a higher prevalence of the alteration in NMIBC patients. So we're looking at these patients, randomizing them to receive the drug-releasing system known as the TAR-210, which has a zero-order kinetics release of erdafitinib. And so you insert and replace every 3 months or every 12 weeks, which is actually a really nice dosing schedule. And they'll be randomized against intravesical therapy, investigator’s choice, gemcitabine or mitomycin. That's a very real-world decision point. So this is super exciting. It's a trial in progress. I love this kind of a study because it's very urology friendly. We can basically have these types of releasing systems which you can have off the shelf in your clinic.
And also the data previously on TAR-210 from earlier first-in-human studies and other earlier studies as part of the MoonRISe program, which is the TAR-210, erdafitinib; the TAR-200 is the gemcitabine program. There's 5 trials in that: SunRISe-1, 2, 3, 4, 5. Overall, very good tolerability. Patients may get some mild lower urinary tract-type symptoms and very much in the wheelhouse for urologists to insert and remove. So an exciting trial. Look forward to reporting it to you at a future time once we start to get the readout on the data.
I'm Neil Shore at AUA 2025 in Las Vegas. Thanks very much.
Announcer:
You have been listening to DataPulse on ReachMD. This activity is provided by Prova Education.
Thank you for listening.
Share this program on:
Choose a format
Completing the pre-test is required to access this content.
Completing the pre-survey is required to view this content.
Ready to Claim Your Credits?
You have attempts to pass this post-test. Take your time and review carefully before submitting.
Good luck!
Details
Related
Overview
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
Recommended
Details
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
Title
Share on ReachMD
CloseProgram Chapters
Segment Chapters
Playlist:
advertisement
Recommended
Register
We’re glad to see you’re enjoying ReachMD…
but how about a more personalized experience?