Zachary Klaassen: Hi, my name is Zach Klaassen, urologic oncologist at the Georgia Cancer Center in Augusta, Georgia. We are at AUA 2025, in Las Vegas. I'm delighted to be joined by urology resident doctor Pietro Scilipoti from San Raffaele in Milan, Italy. Pietro, thanks so much for joining us on UroToday.

Pietro Scilipoti: Thank you for the invitation.

Zachary Klaassen: So you presented some great data at the AUA 2025, looking at the Euro Gem/Doce group and the experience with Gem/Doce in this BCG-unresponsive non-muscle invasive bladder cancer space. So before we get into your trial, let me just set the stage of what this landscape looks like, how Gem/Doce does sort of fit into it.

Pietro Scilipoti: Well, it is, actually, I think the most active part of the bladder cancer in general, because there are a lot of options right now, especially in the US. In Europe, right now, we are still having approved other treatments, for example, nadofaragene, which has shown some data that is quite promising. The use of Anktiva, for example, plus BCG is also another option that has been used in the US and pembrolizumab.

Europe, actually, we don't have all these options right now approved, at least not in all countries. And Gem/Doce, which has been used for a long time in the US-- in the US since 2015, actually-- it's been used also by many centers in Europe now as an off label treatment. We can say since 2021, actually. So I think it's a very interesting landscape. And it's because patients just don't want their bladder removed with a non-invasive cancer.

Zachary Klaassen: Yeah, absolutely. No, it's a great summary. And maybe just set the stage for your study design that you presented this week.

Pietro Scilipoti: So yes, I personally believe this is a very important study. We built this Uro Gem/Doce group, which involves 12 centers from Europe. Probably in the next follow up will probably include all the centers that are starting with the Gem/Doce.

Zachary Klaassen: Yeah.

Pietro Scilipoti: And these groups that provided the data, actually, they come from Italy, there are centers from Spain, there are centers from France, there are centers from Poland. So actually, there are a lot of centers from Germany, as well, that were involved. And this was done, also, in collaboration with the Young Academic Urologist within the EAU guidelines group.

And we were able to retrieve data from our first batch of data of almost 100 patients.

Zachary Klaassen: Excellent.

Pietro Scilipoti: Afterwards, we selected only those that were exposed to BCG, which were around 75 in the study.

Zachary Klaassen: Yeah, excellent. And what were the key findings from your study?

Pietro Scilipoti: Well, first, what we found was, actually, that we had around 65% of patients with BCG unresponsive disease. The rest was either relapsing, not defined as unresponsive, or BCG intolerant, which were around eight patients.

Zachary Klaassen: Sure.

Pietro Scilipoti: The main finding was actually, first, the good efficacy with a 9-months median follow up, considering only those patients that did at least an induction course with at least one first follow up evaluation. We had a 73% high grade-- 79% high grade disease-free survival, and a 73% disease-free survival, in general, with a 95% one year progression-free survival, which is quite promising.

Zachary Klaassen: Excellent.

Pietro Scilipoti: And the tolerability was also awesome. We found mostly grade 1, 2 adverse events. The grade 3, 4 were quite uncommon adverse events for these patients were mostly fever. And yeah, it's very good data.

Zachary Klaassen: Absolutely. And I think when we see data like this, it's good centers, it's well organized. And we've seen it in the US. The University of Iowa has done a ton of work, for example. How do we place Gem/Doce in this new landscape? Let's say we have all the agents available. How does it fit in? How do you see that?

Pietro Scilipoti: Well, the BCG, for example, in the last systematic review, they advised it, actually, as a possible option for BCG-unresponsive patients.

Zachary Klaassen: Yeah.

Pietro Scilipoti: I believe that, right now, unfortunately, all the data is retrospective compared to all the trials that are available for the other options. So we need always to keep in mind this and to make, also, the patients aware of this. But it's still an option, because the prospective data shows, consistently, since 2015, good efficacy, which actually has improved over time.

The first publication, 2010, actually, the first multicenter publication, we had a recurrence-free survival, which was a little worse than the most recent publications. For example, the last publication from the multicenter publication from Taylor, which showed pretty much our estimates from, also, our study.

Zachary Klaassen: Yeah.

Pietro Scilipoti: So it's an option. It's not so expensive. It can be considered. But we need always to remember that this needs further validation in a prospective context. So that's the main takeaway, I think.

Zachary Klaassen: Congratulations on the Uro Gem/Doce group and the collaboration. Maybe just a couple take home messages for our UroToday listeners.

Pietro Scilipoti: Well, I believe that-- first of all, we believe that we hope this treatment in Europe will finally become not off label and actually an option.

Zachary Klaassen: Yes, sure.

Pietro Scilipoti: And that's the purpose of this study. But based on this, I actually I think this could be very promising for our patients that do want to keep their quality of life of a non-infiltrative disease.

Zachary Klaassen: Yeah.

Pietro Scilipoti: And this is-- I think, the main message is, it's an option. Hopefully, one day, we'll have prospective data.

Zachary Klaassen: Sure.

Pietro Scilipoti: Also for BCG unresponsive, because right now, there are trials for BCG-naive patients. And yes, that's, I think, the main finding that we have.

Zachary Klaassen: That's a great conversation. It's always good to see our European cohorts at AUA. And thanks for joining us on UroToday.

Pietro Scilipoti: Thank you very much.