Transcript
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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