Ashish Kamat: A warm welcome to all of you from the UroToday studios. I'm Ashish Kamat, urologic oncologist from M.D. Anderson Cancer Center in Houston, Texas, and we're live at AUA 2025 here in Vegas. It's a pleasure to welcome you, Professor Felix Guerrero-Ramos, to the studios. Welcome, Felix.

Felix Guerrero-Ramos: Thank you so much. It's a pleasure for me to be here.

Ashish Kamat: So you've got a lot of stuff going on at the AUA. But one thing we really want to hear from you in this session is your presentation on the SunRISe trial, so cohort four. So tell us the latest on what's happening.

Felix Guerrero-Ramos: Well, I've been glad to present the very first results of the papillary-only disease cohort, which is cohort 4 SunRISe-1 trial. And we have to bear in mind that among all those BCG-unresponsive patients, 90% of them are pure papillary-only disease, not CIS. So these are the first results of the cohort 4, including those patients with papillary-only disease who underwent treatment under TAR-200.

And we have found a very promising disease-free survival rate. 85% of the patients remain disease-free at six months, and over 81% of the patients remain disease-free at nine months. In future conferences, we will update the survival to one year. But these data seem much better than what has been previously reported with other drugs.

Ashish Kamat: So expand on that a little bit. So what we understand about papillary in your cohorts in different studies is clearly you can't control for the surgeon when it comes to resection of disease. But mechanistically, the drug still makes sense. I mean, if it's going to work to prevent recurrences, it is also going to work to prevent recurrences in papillary disease. So with that in mind, put those numbers in context. What is your expert opinion?

Felix Guerrero-Ramos: Well, I think number one for all these trials, there is a cystoscopy at the screening period. So we make sure that the tumor is fully resected. And after that, we know that DFS is the primary endpoint in these trials. Because differently from CIS where we're looking for a complete response, we have just fully resected the tumor, and we are trying to avoid recurrence or progression.

I think that the current standard of care for these patients nowadays is radical cystectomy. And patients do not really want to undergo radical cystectomy, especially in this localized disease. And 82% of the patients in this study declined radical cystectomy, as 18% were ineligible. So I think that still follow-up is short. This is a cohort with 52 patients. This might be the main drawback of the study.

And to answer more confidently these questions, we have the SunRISe-5 trial, which is randomizing patients with papillary-only disease to either intravesical chemo or TAR-200. But I think and I believe this is a very promising therapy to try to spare bladders in our papillary-only disease BCG-unresponsive patients.

Ashish Kamat: And you talked about the window of opportunity and patients wanting cystectomies. I think as the field has evolved, we've also learned that now we're better at selecting patients for bladder-sparing therapies. It used to be that we felt that only three months or only six months, and you have to take the bladder out. Now we feel, well, we can try one line, second line therapy, et cetera. With that in mind, share with us some of your insights into the TAR-200 program overall, not specifically the cohort 4.

Felix Guerrero-Ramos: Well, just to be very short about the cohort 4, only one patient had a disease progression. Three patients underwent radical cystectomy, and from those, only one had a disease progression in the pathology. I think that we have learned that we can be more confident managing conservatively these patients.

There are data coming from the paper from Karim Chamie with Anktiva. There are some other papers in the British Journal of Urology. I think and I believe that in the non-muscle-invasive field, TAR-200 as well as other therapies, but especially TAR-200, will let us spare more bladders for our patients. And I think, especially in academic centers like yours and mine, we have less fear to preserve these patients' bladders. And in the future, for sure, we will be performing fewer radical cystectomies in these patients.

Ashish Kamat: Yeah, no. Exactly. So when it comes to more for our audience, obviously, insertion, removal of the device, what's the schedule on the protocol? And how have you found that to flow into the clinic flow, for example, when you are doing these?

Felix Guerrero-Ramos: Well, the schedule is quite simple. For the first six months, there is a new device placed every three weeks, and then thereafter, every three months, you have a three-week device inside, up to two years. That's the general schedule for this.

This has not been difficult to implement in our center. I think we're one of the centers with more patients enrolling TAR-200 clinical trials. The insertion and removal are very easy procedures for any urologist. You don't have to be an academic urologist. Any community urologist is used to do catheterizations or whatever. So it's as easy as catheterizing the bladder and inserting the device. And for removal, it is as simple as a cystoscopy, and as if it was a pigtail catheter.

There is something that we have analyzed in this SunRISe-1 trial, and it is the insertion success rate. And it demonstrates it is an easy procedure. 99.5% of the insertion procedures were successful. So it is an easy procedure. And I would say it has a learning curve of two or three or four cases.

Ashish Kamat: Great. Great. Any closing thoughts based on your experience so far or based on your presentation?

Felix Guerrero-Ramos: Well, not only for TAR-200, but for this plenary at AUA, we have been several years seeing how bladder cancer is evolving. We have exciting times ahead. And I believe that all these new drugs, devices, technologies will help us. And I'm sure in 10 years, the bladder cancer landscape will be totally different from what we are used to.

Ashish Kamat: Our patients deserve it.

Felix Guerrero-Ramos: Yeah, that's it. That's it.

Ashish Kamat: Absolutely. So thank you so much, Felix, for taking the time.

Felix Guerrero-Ramos: Thank you, Ashish.

Ashish Kamat: Always a pleasure.

Felix Guerrero-Ramos: It's been a pleasure.