Ruchika Talwar: Thank you. I'm so excited to be here today and share a little bit of our research that we recently presented at GU-ASCO.
Ashish Kamat: Yeah, we often talk about new innovations. We talk about new treatments, of course, UGN-102 for recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer is approved in this setting. It's something that we've all sort of figured out how do we use, which patient population, but one of the things that's really important for our shared decision-making is the patient experience. So really excited to have you here and share the poster that you presented.
Ruchika Talwar: Absolutely. Exactly, as you mentioned, I think patient-reported experiences with UGN-102 and a particular focus on how these data can inform shared decision-making is just a critical part of us integrating this new sort of product into our clinical algorithm. As you mentioned, we did present this poster at GU-ASCO. It is a pleasure to be here and dive in more for this audience. Before I kick things off, just a couple disclosures here. In addition to financial disclosures, I do just want to state that certain slides in this presentation were developed and shared by UroGen Pharma as a courtesy. It is an independent presentation and UroGen was not asked to review or approve this at all. So let's start a bit with the clinical problem here. For recurrent low-grade, intermediate-risk, non-muscle-invasive bladder cancer, we are all very familiar with this pathway, including the use of repeated TURBT interventions for these patients when they end up recurring. But this really is a chronic recurrent disease and patients require multiple of these procedures over time. The clinical challenge or clinical space that UGN-102 is filling here is a different sort of paradigm. It's a chemoablative intravesical approach using a reverse thermal hydrogel formulation of mitomycin. The phase three ENVISION trial evaluated the efficacy of this approach. Again, what I'm going to focus on today, personally, what I think is particularly important and often under discussed is how do patients actually experience these treatments? Because in a chronic disease space like this, treatment burden and quality of life really are central to decision-making, alongside oncologic control. The analysis that we presented here combines two key components.
First, we have prospective patient-reported outcome data using the EORTC Quality-Of-Life Questionnaire NMIBC24. Second, and actually I think more uniquely to this study, we also included qualitative patient interviews comparing prior TURBT experiences to UGN-102. Just very briefly, the ENVISION study design here, I'll review six weekly intravesical instillations of UGN-102 with interviews at baseline and at three months. Again, important to note, these were US-based patients who had prior TURBT experiences, and they were drawing upon direct comparison from the patient perspective of that prior TURBT. The ENVISION study enrolled 240 patients overall, and we had a subset of 29 US patients completing both interviews. The key points here; the majority of patients were over 65, most had multiple tumors, many had multiple prior TURBTs, and so this is really representative of that patient population we see in the real world in clinic, patients who are used to these repeated interventions. This really is the heart of the study here, the patient voice. From the interview cohort, 29 patients, as I mentioned before, completed both interviews out of the 41 eligible patients. We identified several important themes here. You see specifically that patients described this idea of interference with routines. TURBTs and the repeated TURBTs specifically interfered more with daily life. There was a longer recovery, more disruption to work and activity. This often meant, for example, about one week of disruption with the TURBT versus one to two days with UGN-102. Urinary symptoms were actually similar between both potential treatments, TURBT or chemoablative therapy. Patients described dysuria, frequency, urgency, which aligns with the patient-reported outcome data I'll share in just a moment. There were bleeding concerns. Patients did express greater concerns about bleeding with TURBT, and the majority of patients would recommend UGN-102 as a less invasive, less painful, and less time-consuming intervention as compared to TURBT.
I do want to note that a small subset of patients did indeed prefer TURBT, and the stated reasons were that it's a single procedure compared to six weekly treatments. I think that really highlights that there can't be a one-size-fits-all answer. Preferences are going to vary. Patients are not just comparing things like efficacy, they're thinking about recovery time, disruption to life. That may mean different things to different people, and procedural burden, which also may mean different things to different people. Here's a snapshot of the patient-reported outcome survey data that was collected. I think this really allows us to connect that qualitative experience to the quantitative data. You see that there is no clinically significant meaningful deterioration from baseline, comparing TURBT to UGN-102. In general, when you look at the quality of life change from baseline scores, you see that they really are similar across multiple domains; malaise, sexual function, urinary symptoms. I think the key message here is that UGN-102 does maintain quality of life without introducing any new or sustained symptom burden. Before I dive into the conclusions, I want to just call out a few important limitations. First, this is a single-arm study design. There's no direct comparison between patient-reported outcomes or the qualitative interview data regarding TURBT versus UGN-102. This is really a potential recall bias that we have introduced here because patients are referring to their prior experience with TURBT, and it was a relatively small qualitative sample size of 29 patients. I still think it's important that we synthesize this data in the context of the conversations we're having in clinic. Again, just reinforcing here that patients perceive less disruption in general, less invasiveness in general, and faster recovery. I think it's important to call out that a small subset of patients actually did prefer a single procedure.
Again, it's not a one-size-fits-all magic bullet here, but I think this data really does arm us with the data points we need to have these kinds of conversations in clinic when patients ask us, "Hey, Doc. I'm considering something like UGN-102. What is that experience going to be like compared to TURBTs that I might have had in the past?" So with that, happy to dive into any questions. I appreciate, again, the opportunity to be here.
Ashish Kamat: Ruchika, once again, wonderful presentation. As I've seen you do over the years, you covered all the points, including the limitations. You actually answered a lot of my questions that I was going to ask you about this study, which is great in some ways, and it also allows me to dive in right to the money question. How do you actually use this data, and of course, the efficacy data and everything you know about it, to talk to a patient in front of you in clinic that's sitting there with the low-grade, intermediate-risk NMIBC?
Ruchika Talwar: Yeah. It's a great question. When I think about this new tool, I think about it being just another toolkit in our armamentarium. What I mean by that is I think for patients, in general, we perceive TURBT to be low risk. I think that's true actually in most patients. However, we know there's a subset of patients who are on anticoagulation, who have significant comorbidities, who might require, for example, a pre-admission for something like a heparin drip. That's really where I think this new chemoablative option shines. There are patients in whom a TURBT is not just a simple outpatient procedure. Personally, that is really where I lean on this sort of product, as giving me an option to achieve cancer control in an otherwise challenging setting. Beyond that, there's a subset of patients who do really poorly with TURBTs because they might have had chronic bladder-related changes due to repeated instrumentation. There could be some other bladder pathology at baseline. Again, knowing that there's no difference here, in some of those urinary symptoms or patient-reported outcomes, it's just another thing I can talk to patients about in the clinic if they are that subset of patients who has a really bad experience with TURBT.
Ashish Kamat: Yeah. Excellent points. I think kudos to the team, and of course, Dr. Schoenberg, who leads the effort for actually focusing on the low-grade, intermediate-risk bladder cancer patients, because there's less of a fear that we're doing any harm to these patients. As you know, the IBCG has championed this for years and he followed that, and of course it's in the NCCN guidelines. As part of the NCCN guidelines and what we've done for many years, and of course you are part of the IBCG now, so you know this just as well as I do, we also have buckets and scores. We try to de-intensify treatment and ramp up treatment, essentially making sure that patients get the appropriate treatment at the right time. How do you factor in the new paradigm of active surveillance for some of these patients? How do you factor in UGN? How do you factor using non-UGN mitomycin into the lower risk patients that could otherwise get those? How do you discuss those with the patient?
Ruchika Talwar: Yeah. It's a great point you bring up. No two patients are the same. When I think about a patient in whom I might want to use UGN-102, again, it's less likely to be the patient in whom active surveillance is probably a good option, because I think de-intensification of treatment is really important and something we have to continue to do more of, quite frankly, because we want to maintain quality of life, if cancer control is not necessarily going to shorten their lifespan. This is more for the patient who, again, is having ... Maybe they're a patient who's on active surveillance, whose low-grade cancer looks to be like it's increasing in burden. They haven't flipped to high grade yet, they're still not high risk, but I'm not super comfortable continuing to surveil them. Surgery may be high risk or may require a lot of effort from the patient, again, if it requires some sort of pre-admission with their comorbidities.
That's really the sweet spot. I just want to point out one thing. I think that patient choice is really important. We've seen this in prostate cancer, for example, when patients are deciding between surgery, radiation, maybe in some cases, some of these newer therapies, focal therapy, et cetera, that might be out there. We are giving the patient more autonomy in deciding the route they want to take. For some patients who might otherwise be great active surveillance candidates, maybe cancer control is important to them, and maybe that's a quality of life point for them. Again, here's another option, not as extreme as needing to go to the operating room, but still helping the patient choose a more active treatment choice as compared to surveillance. I think everything has its place, and yet again, I think what a great option to now have one more little tool in our toolkit in this case.
Ashish Kamat: Yeah. I think anytime we have more options that we can offer patients, it's a win for the patients, for us, and our community, in general, because as you said, no patient is going to be the same mindset. Some may not be able to come to the office, some are totally fine coming to the office every week, and it really is up to the patient to help guide ... We have to guide the patient, but then they have to guide us as to what they would feel most comfortable with. I think having data such as these that speaks to quality of life and patient-reported outcomes is always very important. Thank you so much, Ruchika, for taking the time. Always a pleasure.
Ruchika Talwar: Thanks again.