Zachary Klaassen: Hi, my name is Zach Klaassen, urologic oncologist at the Georgia Cancer Center. We are on UroToday at ASCO 2025 in Chicago. And delighted to be joined by Dr. John Sfakianos, who is a urologic oncologist at the Mount Sinai Icahn School of Medicine. John, thanks for joining us on UroToday.

John Sfakianos: Zach, thank you for having me.

Zachary Klaassen: So we're going to talk about a subgroup analysis of ENVISION and really looking at some of the nuances in this low-grade, intermediate risk non-muscle invasive bladder cancer population. So maybe just tell us a little bit about the study, what the intention to treat analysis initially showed?

John Sfakianos: Yep, thank you very much, Zach. And so ENVISION was a phase III single-arm study that used UGN-102, which is a reverse thermal biogel or hydrogel that was instilled with mitomycin. And it was given once a week for six weeks in patients with low-grade, intermediate risk bladder cancer.

And the idea here was almost trying to do a chemo ablation so we don't have to constantly take patients to the OR, with the endpoint being a clinical response at 3 months and then at 12 months as well. Both that data, the ENVISION trial was a positive trial that showed an approximately 80% three-month complete response rate. And then of those patients who responded, you had about an 82% 12-month durable response.

Zachary Klaassen: All right. Excellent. And so we're avoiding TURBT on some of these comorbid patients?

John Sfakianos: Exactly. That's exactly the idea. If you remember or think back to a lot of these meetings with these patients, there's been this argument about doing surveillance. That's been something that says, hey, we don't need to treat these patients. Just watch them. Personally, in my practice, I think that's a very challenging thing to convince my patients to say, hey, you've got a tumor in your bladder. Don't worry about it.

Zachary Klaassen: We'll check it again in three or six months.

John Sfakianos: Yeah. So this is now a nice option for our patients.

Zachary Klaassen: Absolutely. So tell us a little bit about the subgroup, why you guys did it, and what the message is from that?

John Sfakianos: Yeah, I think the subgroup is a really important analysis. And with enough events, I think it was very important to do this because the question is, is this something that we can actually just widespread use in our practice or do we have to be selective in our patients?

And so this subgroup analysis looked at tumors that were less than 3 centimeters versus those that were greater than 3 centimeters. And then we looked at multifocal versus single tumors. The punchline here, the end result is it doesn't matter. So you can use this on all your patients who have intermediate risk, low-grade bladder cancer. You don't have to think about it. You don't have to have a selection bias for these patients. It is easily just instilled and given to everybody.

Zachary Klaassen: That's great. I think especially that size criteria is important, too. I think that's a nice take home from that sub-analysis. As we position UGN-102 into our practice, as approval comes through over the next few months, how are you going to position this? How do you talk to your patients about this option?

John Sfakianos: So I think it's a great option because we didn't really have many options. So this is an option now. Because like I said previously, I would try not to take a lot of these patients to the operating room. You would try to burn some of these tumors in the office. You would try to do anything you could to minimize recurrences without maximizing your actual burden on the patient.

And while this does have a little bit of burden, meaning coming in once a week for six weeks, I think that this is a great option where you don't have to fill your OR schedule now with these TURBTs, these sicker patients, these older patients that you don't necessarily want to take to the OR. Patients on anticoagulation and all these things that they would need to stop and become a big deal.

So I do think that this is going to be really important in my practice. Going to offer it to a lot of these patients that I see. And I think that these results are great because, like I said before, I don't have to think about it. You have an intermediate risk, low-grade bladder cancer. Doesn't matter if you have 10 tumors, 1 tumor, great big tumor. Just give it to all your patients.

Zachary Klaassen: I think, too, when I look at this as well, we're not losing anything. If it doesn't work, we take them for the TURBT. And we know roughly 15% complication rate with TURBT, mostly the elderly, the frail. So I think if we take that all together, it's a nice package.

John Sfakianos: Yes, completely agree.

Zachary Klaassen: Any take home messages, anything we haven't hit on that you want to talk about?

John Sfakianos: No, I think we hit on all the highlights of this study and this trial. I think it's going to be important to make sure that patients understand that now they have an option. And now we, as physicians, can clear up our OR schedule a little bit with not having to fill up all these low-grade tumors--

Zachary Klaassen: We're all busy.

John Sfakianos: Right. exactly. So this is a great option for both the physicians and the patients. And glad that we have this available now for them.

Zachary Klaassen: Yeah, great take home. Thanks so much, John, for joining us on UroToday.

John Sfakianos: Thanks, Zach.