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OPTIMA II Five-Year Data: Mitomycin Chemoablation Provides Durable Response in LG-IR-NMIBC - Neal Shore

November 17, 2025

Neal Shore to discusses chemoablation with mitomycin (ZUSDURI™) for low-grade intermediate-risk non-muscle invasive bladder cancer. Dr. Shore explains that this patient population represents a substantial group, potentially 25,000 to 50,000 patients annually. The reverse thermal hydrogel formulation contains mitomycin and transforms from liquid to semi-solid after instillation, extending dwell time up to 24 hours. Dr. Shore presents five-year data from the OPTIMA II trial demonstrating approximately 60% complete response rates at three months, with the overwhelming majority of responders maintaining durable responses beyond two years. Ideal candidates include patients with recurrent disease, multiple lesions, or those seeking to avoid repeated TURBTs. The once-weekly six-week regimen requires no maintenance therapy and can be nurse-administered.

Biographies:

Neal Shore, MD, FACS, Director, CPI (Certified Principal Investigator by the Association of Clinical Research Professionals), Medical Director, Carolina Urologic Research Center and the START Center for Cancer Research Institute, AUC Urology Specialists, Myrtle Beach, South Carolina

Zachary Klaassen, MD, MSc, Urologic Oncologist, Assistant Professor of Surgery/Urology at the Medical College of Georgia at Augusta University, Wellstar MCG, Georgia Cancer Center, Augusta, GA



Related Content:

UroGen Announces New Data from the OPTIMA II Study that Show Median Durability of Response of 24.4 Months for UGN-102, an Investigational Non-Surgical Chemoablative Treatment for Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer

WSAUA 2025: Treatment of Low Grade Intermediate Risk Non Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-year Long-Term Extension Study of the Single-Arm, Phase 2b Optima II Study

Expanding Treatment Options: FDA Approval of Mitomycin Intravesical Solution for Recurrent Low-Grade Intermediate-Risk NMIBC - Sandip Prasad

Refining Risk in NMIBC: Intermediate Stratification, TURBT Quality, and Emerging Options - Katie Murray
Read the Full Video Transcript

Zachary Klaassen: Hi, my name is Zach Klaassen, Urologic Oncologist at the Georgia Cancer Center in Augusta, Georgia. As always, I'm delighted to be joined by Dr. Neal Shore, urologist in Myrtle Beach, South Carolina. Today we're going to be discussing low-grade intermediate-risk non-muscle invasive bladder cancer and chemoablation, really focusing on patient selection and who to really think about treating first. So Neal, thank you as always for joining us on UroToday.

Neal Shore: Great to be with you, Zach.

Zachary Klaassen: Just to level set for our listeners, I just want you to maybe highlight, how prevalent is intermediate-risk disease? Why is there a need for new therapeutic options in our clinics?

Neal Shore: Yeah, it's always hard to say with exactitude, but you know what, if we diagnose every year roughly 80,000 patients with non-muscle invasive bladder cancer, maybe a third are high risk, the poorly differentiator, the Grade 3s, the CIS and the T1s, and another two-thirds are not high risk. And so there's the low risk, which are almost like a nuisance, and maybe it's 20 to 25,000. And then there's that intermediate-risk bucket that goes in there. And of that intermediate risk, that's the low-grade intermediate risk, it's really the overwhelming majority of that group.

So it's not a non-substantial prevalence. It's quite a significant number of patients, anywhere from 25 to maybe 40, 50,000 patients. Part of it's the histopathology. I think what's really a pretty landmark for ... if that's potentially the best way of thinking about it, is the approval of UGN-102 based upon multiple different trials, but that got FDA approval back in the late spring of this year, is the first and only to-date intravesical therapy for this disease population.

Zachary Klaassen: Right. And I think too, you just mentioned there's been multiple trials, the ATLAS trial, the ENVISION trial, and you guys just published the OPTIMA II trial with five-year results. Maybe just walk our listeners through what that trial was and what those five-year results showed.

Neal Shore: Yeah, happy to do that. I mean, just for the folks who are listening, what is UGN-102? It's this very novel reverse thermal hydrogel. It contains mitomycin, a well-known intravesical chemotherapeutic that we've been using globally for years. But when you use this reverse thermal gel, it gets inserted as a liquid and it becomes a semi-solid. So it basically increases the dwell time for several hours to even up to 24 hours for some patients. And it just gets voided spontaneously.

Before I forget, we've submitted some really great long-term data looking at both the OPTIMA II and several other studies, a total of four, combining the safety and tolerability. We've submitted that. Hopefully we'll see that presented I'm hopeful at AUA this year. Really, really nice. Several hundred patients and the safety data is quite impressive. And that's always one of the first things that people want to know about. Yeah, we want to see clinical efficacy.

And in OPTIMA II, to your point, Zach, getting back to your question, we had 63 patients that started in it and we had almost a 60-plus % CR, very early at three months. We had a great follow-up. And ultimately, in that study, what really was done was just ... It was once a week for six weeks. No maintenance therapy required, intravesically given. And the duration of response to the patients who did respond past two years and then out to five years is the overwhelming majority.

So that's always an important question, is of those who responded, how long do they continue the response? And that's what we basically saw. We had previous two-year data. Now we have four plus-year data demonstrating that, in addition to a really very, very good safety adverse event profile.

Zachary Klaassen: Yeah. And I think too, to your point, this is a group of patients that just recur, recur, recur. So to have that durability really speaks to the biology and the technology to treat these patients with chemoablation and have response.

You mentioned the FDA approval in June of 2025. Somebody's listening to our discussion, they're thinking about getting into UGN-102 for their patients. Who's those first patients they should go ... Who's the low-hanging fruit that they should try this on, and maybe discuss some of the patient factors you're looking for to treat these patients?

Neal Shore: Yeah. So in OPTIMA II, the overwhelming majority of patients had had multiple recurrent TURBTs. I think probably right out of the gate, we're doing a well-performed TURBT. It's always the sine qua non for what we do, making sure we try to get complete resection. If there's any kind of concern, making sure we're getting muscle too, if it's reasonable. It's a judgment call.

But having said that, I think the ideal patient, it could be a male or female, but it's really what we saw in OPTIMA II was that 50% of these patients were recurrent, had had multiple TURBTs. I would say that if you've got somebody who is recurring within one year of a resection, certainly patients with multiple lesions, patients who are really averse to having another anesthetic, averse to being instrumented with a cystoscopic TURBT, don't want to take the time off, concerns about having an indwelling catheter, that's the bucket. It's a pretty wide bucket of patients.

The instillation is very simple. It's done by a nurse. We actually had a trial where patients were able to deliver a therapy with nurses in the home. I didn't participate in that, but that was done globally and it was very successful, which is another interesting aspect commenting on the safety and the tolerability and really where maybe things are moving in terms of intravesical therapies for this and maybe some other different drug possibilities.

Zachary Klaassen: Yeah. No, that's great. I think you mentioned that your nurses are giving it. Maybe just expand a little bit on your workflow, how it's been easy to incorporate into your clinic?

Neal Shore: Well, yeah, I mean, it's just that classic once a week for six weeks. In the study, pretty much both in OPTIMA II, which was our phase 2b, and then the registrational studies that looked at ENVISION and ATLAS combined when they presented to FDA, it's only a low single-digit percent. I think it's less than 5% that didn't receive the once-a-week, six-weekly instillations.

So your classic catheter insertion and put in the liquid medication, it becomes a semi-solid, again, the improved dwell time. And then there's no maintenance, there's no monthly. And we have a lot of great therapies that have become available in the BCG unresponsive. Many of them are going to try to move into the high-risk BCG-naive, and many are looking at the intermediate risk population. But I will say, the schedule of events, to your point, once a week for six weeks, it's about as simple as it gets without a maintenance regimen.

Zachary Klaassen: Yeah. That's very, very helpful. Neal, always great chatting with you. Any take-home messages, anything we haven't hit on you want to tell our listeners?

Neal Shore: No, I love the opportunity to talk about this. It's an exciting time in non-muscle invasive bladder cancer. We didn't talk about the high risk. That's a whole other separate conversation. The BCG high-risk, the BCG unresponsive, but now intermediate, the low-grade intermediates, which is a pretty significant number of patients. And so I think for our listeners is just, you don't need to be relegated to just traditional intravesical options now that UGN-102 was approved by FDA June 2025.

Zachary Klaassen: Absolutely. Thanks to our listeners for tuning in. Neal, thanks for joining us on UroToday.

Neal Shore: Pleasure. Thanks, Zach.