Good morning, and welcome to UroGen Pharma's presentation of duration of response results from the ENVISION study. Earlier this morning, we issued a press release and filed an 8-K summarizing results from the duration of response endpoint from the ENVISION pivotal study of UGN-102 in low-grade intermediate-risk NMIBC. The press release can be accessed on our investors' portion of our website. During today's presentation, we will be making certain forward-looking statements.
These may include statements regarding our ongoing and planned clinical trials, commercial and clinical milestones, market and revenue opportunities, the potential benefits of our product and product candidates, our commercialization strategy and expectation, as well as potential future commercialization activities for UGN-102. If approved, data results, including ENVISION durability data, regulatory filings and decisions, and the timing thereof, including the potential for UGN-102 to receive priority review, future research and development efforts, and our corporate goals. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements, and UroGen disclaims any obligation to update these statements.
I'm Dr. Arie Belldegrun, the Chairman of UroGen Pharma. Welcome to UroGen's New Horizons data event. I started as a resident at Harvard, at the Brigham and Women's Hospital many years ago, over three decades ago. I was taught how to treat patient with non-invasive urothelial cancer. In a word, surgery: cut the tumor out. Not much has changed since other than the work that we at UroGen have done for patients with non-invasive bladder cancer. Today, we'll unveil the results of the groundbreaking ENVISION pivotal study of UGN-102, a novel investigational treatment for non-muscle invasive bladder cancer that advances our vision of treating cancer in a completely new way. Since UroGen's inception, its mission has been clear: to lead innovation in urologic oncology. The company started small, but with a big idea, to develop a non-surgical technology that could change how cancers are treated.
The RTGel platform, with the elegance of a reverse thermal gel, allows the power of its therapies to stage an attack on cancer without surgery. What was developed is a game changer. The data UroGen will share today is a pivotal moment in its history and for the field. With innovative strategies, groundbreaking research, and unwavering dedication, it stands poised to redefine the cancer treatment landscape. In medicine, innovation turns hope into possibility for treatment, recovery, and a better tomorrow. At UroGen, we're dedicated to preserving and expanding those possibilities for patients at every turn. Thank you for joining us on this extraordinary journey. I would like to turn it over to Liz Barrett, President and CEO of UroGen, the visionary leader spearheading UroGen's charge towards groundbreaking advancements in urothelial cancers.
Thank you, and thank you, everybody, for being here today. Welcome. I could not have said it better than Arie did on the video, and really appreciate him joining us today. As you can see, we have a packed agenda for you today. We're gonna talk about the data that has just recently been released. You'll hear from patients, and you'll hear from patient perspectives. We will have a panel discussion of esteemed urologists in this space, and then we'll talk, we'll give you an opportunity to ask some questions. So really looking forward to today. As a matter of fact, I would say it was almost a year ago, and that we've been anticipating today for our company. As Arie mentioned, you know, we started this company because we felt like patients deserved better.
That is because in urothelial carcinomas, as Arie also mentioned, not much had been happening, and for the most part, these cancers had been ignored by companies, and you saw this repetitive cycle of surgical intervention. We are pleased that we have a pipeline of products for urothelial cancers.
... In 2020, we launched the first and only FDA-approved treatment in Jelmyto for low-grade upper urothelial cancer. Today, we talk about the most much-anticipated UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer. And lastly, we have a pipeline behind this, with UGN-301, bringing a very unique approach to treating high-grade cancers. So we're really excited about the progress that we've been able to make over the years to really change the treatment paradigm for these patients. As Arie also mentioned, our company was really based and founded on the RTGel proprietary reverse thermal hydrogel technology. Urologists identified an opportunity and a real need in patients for medicines to dwell longer in the cavity, to allow the opportunity for them to kill the tumor cells.
That's when we found a very elegant solution in the RTGel, reverse thermal gel, because it's actually liquid when it's cold, as it hits the warm temperature of the body, delivers the medicine, and allows for sustained release over several hours, disintegrates, and is voided naturally. We talk about bladder cancer. There are over 700,000 people in the United States alone living with bladder cancer. Bladder cancer is a disease of a high rate of recurrence, and as a matter of fact, in our patient population, the low-grade intermediate-risk patient, 68% will have two or more recurrences, and 23% will have five or more recurrences. That leads us to the development plan that we have embarked upon the last few years. We believe that UroGen is uniquely positioned to be a leader in urothelial cancers.
Again, just like Jelmyto, if approved, UGN-102 will be the first and only drug approved for low-grade, intermediate-risk non-muscle invasive bladder cancer. There's over 80,000 patients annually in the U.S. that have this disease. It's a large market, but importantly, we have a very strong, compelling clinical trial database. And it's very easy to use and fits very nicely with how urologists treat patients today. So with that, I'm very excited to turn it over to our emcee for the day and our Chief Medical Officer, Dr. Mark Schoenberg. Mark?
Liz, thank you very much. I do want to say both good morning and tell you what an incredible privilege it is to be part of this program. It's rare in the course of a medical career to be able to participate in something that could potentially change the way we care for patients. And as someone who has cared for bladder cancer patients for almost three decades, I feel very lucky to be here with you this morning. So with that, let me remind everyone the population of patients we're actually talking about treating with UGN-102. As many in the audience, I'm sure already know, bladder cancer, which is a very hot area of drug development these days, comes in many different clinical forms and follows many potential clinical trajectories.
We are actually focused on, as Liz mentioned, low-grade, intermediate-risk non-muscle invasive bladder cancer. This is actually a very common form of bladder cancer, one of the most common forms that, doctors in practice care for on a regular basis. As Liz pointed out, this is a disease that has a very high risk of recurrence and a very low risk of progression. It's a chronic illness, effectively, and typically, it is characterized by, large Ta lesions greater than three centimeters, multifocality, and rapid recurrence. Occasionally, one will encounter T1 tumors, those involved in the lamina propria, but these are not muscle-invasive tumors.
Importantly, the standard of care for the treatment of this patient population is transurethral resection, that is, endoscopic surgical removal of the tumor under anesthesia, followed at least by guideline recommendations, with aqueous chemotherapy adjuvant treatment, although that is rarely used in the United States, based on the peer-reviewed literature, probably only about 20% of the time. It's important to understand what the impact of this surgery is on patients. Importantly, nearly a third will experience some form of postoperative complication after TURBT within about three months of surgery. Progression can occur in this population, particularly those patients who have multiple recurrences. There is even literature to suggest that multiple surgical interventions in this population, which is an older patient population, can be associated with an increased risk of mortality. Low-grade intermediate-risk NMIBC is different than high-grade, high-risk NMIBC.
Let me just point out a few characteristics that differentiate these two clinical entities. As I've said, low-grade disease is a disease of chronic recurrence with a low risk of progression. In contrast, the high-grade disease, which carries with it a significant risk of progression and even the risk of potential metastasis and death. The standard of care for low-grade disease is TURBT, that is surgical removal, using a scope. In contrast to high-grade disease, which is initially scope surgery, followed by agents such as BCG, an immunomodulator therapy. But when that does not work, the standard of care is actually bladder removal. As Liz mentioned, there are many patients with low-grade intermediate-risk disease. We estimate the population to be over 80,000 annually in the United States. The population is slightly smaller for the high-risk population, but again, a different clinical trajectory.
And of importance with respect to the development of UGN-102, there is very little in the field currently being developed to compete with this agent as a primary therapy for the treatment of patients with intermediate-risk disease. There are many trials in the area being developed for high-grade, high-risk disease. These are really not overlapping, and they are very separate clinical development pathways. So just to leave you with this important focus. Again, a large group of patients with low-grade intermediate-risk disease, limited competition currently being developed for UGN-102. And again, this is not a population that is typically treated with BCG these days, particularly because of the shortage of BCG availability. That drug is generally reserved for patients with high-risk disease. Now I'd like to introduce a colleague who's going to take you through our very exciting data.
Dr. Sandip Prasad, a friend and a colleague, is a partner in Garden State Urology and the director of Genitourinary Surgical Oncology for that practice. He has multiple academic affiliations and a sterling history academically of both training and contribution to the academic field of urology. It's with pleasure that I introduce Dr. Prasad, who will now take us through some very important data. Sandip?
Thank you, Mark. Today, we'll be focusing on the duration of response results from the ENVISION study. So just as a review of the data to date for UGN-102, when we look at complete response rates at three months, the phase 2b single-arm OPTIMA II study demonstrated a 65.1% complete response rate at three months. The ATLAS study, which was a phase 3 randomized controlled trial between UGN-102 and TURBT. In the cohort of patients who received UGN-102 alone, the complete response rate at three months was 64.8%. And then in ENVISION, which was a phase 3 single-arm study of 240 patients, all of whom received the study agent, UGN-102, the complete response was 79.6%.
In OPTIMA II and in ATLAS, the population under study was the complete intermediate risk, low-grade, non-muscle invasive bladder cancer population. Within ENVISION, the focus was specifically on those patients that had recurrent disease, namely disease that had recurred within one year, and a focus on those patients specifically. With previously published results on OPTIMA II and ATLAS, we can also see that the duration of response for patients who are in complete response has been observed in multiple trials with UGN-102. In OPTIMA II, the estimated 9-month duration of response by Kaplan-Meier analysis was 69.9%. In ATLAS, for those patients that received UGN-102 alone and demonstrated a complete response rate, the estimated 12-month duration of response was 79.6%. Today, we're going to focus on ENVISION and the demonstration of duration of response data in the ENVISION study.
As a primer, this was, again, a single-arm pivotal study. When we look at the patient population, and these data are now available on the appendix online, the patient population really represents the general low-grade, intermediate-risk, non-muscle invasive patient population. The median age was 70, two-thirds of patients were male, and again, these were all patients that demonstrated a recurrence of bladder cancer within the past year. All patients were followed for a minimum of 15 months in order to obtain a 12-month duration of response result. The primary endpoint for this study was a complete response rate. These are patients who underwent intravesical instillation alone of UGN-102 without surgery and had the bladder re-inspected 3 months later.
These patients had a cystoscopy to evaluate for residual tumor, a biopsy if anything was seen on that cystoscopy, and a urine cytology demonstrating no evidence of cancer cells in the urine. The key secondary endpoint, which are the new data presented today, is the duration of response. These are patients that had the first documented, from their time of first documented complete response until the time of either recurrence, progression, or death. As a reminder, when we look at the ENVISION cohort of over two, of 240 patients, the complete response rate for these patients at three months was 79.6%. When we look at the non-complete response patients, there were only 7 patients or less than 3%, who progressed to high-grade disease. These are our new data for the duration of response for the ENVISION cohort.
We can see here that for the almost four out of five patients who achieved a complete response at the three-month setting, that the estimated duration of response was 82.3% at 12 months. That is, for these patients that had a complete response, the overwhelming majority of these patients remained disease-free at 12 months. Because of the large size of the ENVISION cohort, when we look at the confidence intervals for these estimates, we can see that these are quite narrow, providing confidence that the estimates that are obtained in this study, potentially are durable. So again, at 12 months, the estimated duration of response is 82.3% of patients. For those patients that could be followed further, 15 months and then 18 months, we can see that this duration of response is maintained.
Because so few patients who achieved a complete response subsequently recurred, it is unable to be estimated what the median duration of response would be. However, when we use secondary predictive models such as the Weibull model, which is commonly used in this setting, the median duration of response that's predicted based on the data to date is 40 months for complete responders. That is over 3 years to maintain a complete response for those patients that were complete responders initially, which again, was 79% of the initial cohort. When we look at adverse events, in general, these were quite mild to moderate in severity. The vast majority are based on lower urinary tract symptoms. These are symptoms that urologists typically can manage, and we manage commonly. There were 2 treatment-related severe adverse events. This represents less than 1% of the entire study population.
These two adverse events were urethral stenosis and urinary retention, and both of these were resolved. There were 3 deaths while on study. These were deemed unrelated to treatment. One was a cardiac event, one was a pneumonia, and the third was not reported. As previously stated, many of these patients are former smokers. Many carry concomitant cardiopulmonary disease, and again, these were deemed unrelated to treatment. So again, in summary, when we look at the complete response rate at 3 months, we can see that the ENVISION cohort of 240 patients demonstrates a very robust 79.6% complete response rate at 3 months. Almost 4 out of 5 patients had a complete tumor ablation with topical therapy alone.
Very importantly, we can see here that the 12-month duration of response by Kaplan-Meier estimate for those patients that achieved a complete response was 82.3%. This is the highest duration of response seen in any of the studies and in that population of patients with high recurrence, which again emphasizes the importance of these findings. In summary, if approved, UGN-102 potentially addresses an unmet need for a non-surgical option for low-grade, intermediate-risk, non-muscle invasive bladder cancer. The complete response rate for this non-surgical treatment at 3 months was 79.6%. For those patients that achieved a complete response, the estimated probability of maintaining that complete response for a year, again, in a selected patient population of recurrent patients, was 82.3%. The safety profile here is excellent, and they're characterized primarily by mild to moderate adverse events typically seen by urologists.
In conclusion, if approved, this would represent a new and novel non-surgical treatment option with the potential to reduce the overall burden for patients. Thank you.
Sandip, thank you very much for that exciting presentation, and congratulations. Sandip served as the principal investigator for the international trial that produced these data, and these are really remarkable data, and I think they speak for themselves. So thank you. We're lucky to have an investigator who has actually examined a somewhat less examined aspect of the development of new therapies for bladder cancer, and that is namely, how patients feel about these new therapies. Joining us today is Angela Stover. Dr. Stover is an associate professor in the Department of Health Policy and Management at the University of North Carolina, and it's a pleasure to have her with us so that she can tell us about her work, examining exactly how patients feel about this potentially new therapy as well as the standard of care. Dr. Stover, thank you.
Thank you, Mark. Let's talk about the patient perspective in ENVISION. So, patients with non-muscle invasive bladder cancer commonly ask their urologists how their daily activities or routines, responsibilities are gonna be affected by treatments. In ENVISION, we interviewed patients about the impact on their daily activities with UGN-102, and their recollection of standard of care, which would be TURBT. There were 39 patients eligible in the United States, and we interviewed 29 out of the 39, which is 74% at both time points, and a few patients completed one interview due to availability. So, if you're more of a quantitatively oriented person, let me give you an orientation to content analysis. So this is the gold standard in how to analyze data from patient interviews.
Instead of numbers, the data are patient quotes, so I'm going to be presenting quotes in a few slides. Semi-structured interview guides were used at enrollment and 3 months. So patients were interviewed at enrollment prior to any gel instillations, and that was because we wanted to get their history of TURBTs, ongoing symptoms, et cetera, before they started the trial. And then, we also re-interviewed them at 3 months, to see how they had done during the trial and to ask them to compare their experiences with TURBT and UGN-102. And we chose this study design because in the phase 2b trial for OPTIMA II, we had a potential recall bias with some of the patients because we interviewed them about 6-12 months after they were
after they were done with the trial, and some of them had trouble remembering when their symptoms started, et cetera, if it was due to the gel or prior TURBTs. So with this, at enrollment, we got the history before they started the trial. So transcripts were coded by three experienced coders. We used very detailed code books, and the software we use is called Dedoose. So emerging themes and discrepancies were captured and reconciled through consensus. So three interview themes came up, three major themes and some sub-domains underneath it. For the first one, there was less impact on activities, responsibilities in terms of work, recreation, and exercise, and sexual activity for UGN-102. Patients also perceived that there was less bleeding, and catheter issues were shorter-lasting. And finally, most of the patients would recommend, because UGN-102 was perceived to be less invasive, painful, and time-consuming.
So let's talk about some quotes. One of the sub-themes that came up was recovery time. So on the left in white, these are the interviews from enrollment prior to starting UGN-102. And a patient said: "Well, first off, TURBTs are getting more and more painful. It's taking longer and longer to recover from them. It's just a little bit of every time they do a TURBT, it's a little more incontinence. It's gotten much worse with each procedure." And on the right, at the three-month interview, people said: "Yes, I think it took me a longer time to recover from the bladder resection than the gel.
For TURBT, maybe at 2 weeks, I felt better and things like that, and I start to exercise, but I do believe I was not at my 100% until many weeks later." So the next sub-theme was no impact on daily activities. And on the left, you can see that this was not a theme that we found in the enrollment interviews when we asked about TURBT. We did not have a code for that until the 3-month interviews because we started to hear that about UGN-102. So on the right, a patient said, "With the gel, the daily activity was a big difference, and I didn't worry at all. Basically, I lived my normal life, except the 1 day," meaning the gel instillation, "which was well worth it." And another said, "UGN-102 didn't have any impact on me.
I went in, I went back to my normal activity. I had no problems at all. For impact on work, on the left, for TURBT, a patient said, "It's incontinence, mostly a big embarrassment and an absolute pain in the ass at work. Some days are much worse than others, and depending on what I'm doing, sometimes my pants get wet. I have to go out to the car, get my clothes changed, and they're looking for me. Running to the bathroom all the time, everybody will say, 'Well, you're always in the bathroom.'" On the right, a patient said, "The TURBT, I was basically missing work for 7, 8 days. I could do no work. Here with UGN-102, really, work has continued. I've not had an impact. Again, postponing travel, meetings, things like that, but I was present. Mostly, I was present.
I do think the outcome is better with the gel than the TURBT." Another, major theme that came up was treatment-related side effects, and we did not ask about this, specifically in the interview guides because we were interested in daily routines, and we would not have been able to reconcile any symptoms immediately with the rest of the trial and the FDA. But nonetheless, it came up as a major theme. So on the left, with TURBT, patients were talking about, "I honestly have as much effects from the anesthesia," and they were talking about this, in particular, as they age, that it's getting tougher to recover from the anesthesia every time. Another patient said, "I'll tell you one thing, I do not look forward to spending the rest of my life attached to a catheter.
That's a no-no for me." On the right, "For six weeks, I was in stages of extreme to moderate to low level of pain or itching, extreme internal itching." And another patient said, "It was very itchy on my bladder and everything. The second time, I knew what it was. Knowing what it was, the scary part went away. I wasn't worried anymore. It was just toughing it out for that one or two days." And this was, this was rare. This was only reported by two patients. But they described it as, as itching, extreme itching inside. Next was bleeding. "The TURBT was a lot of bleeding," one patient said. Another said, "They removed five polyps at that time, then I bled for two weeks, finally shut off. My urologist told me that there would be some bleeding.
I don't think he realized that it was going to be that long of a bleeding. He told me that I would be bleeding for a while after the surgery." Then at the three-month interview, we heard, "At least two occasions for TURBT, one of which there was fair amounts of bleeding." And another said, "TURBT was more painful. There was a lot of blood that came out.
Not a little, a lot." And finally, for impact on sexual activity, on the left, a patient said, "Basically, I would like to get away from having the tumors extracted from me because my doctor told me the more surgeries they keep doing, my bladder, especially since I've been doing it so young, that it would mess up good things like erectile function and things like peeing." On the right, they said, "I would say that I didn't have any difference in performance, but I took longer to have relationships with my wife than with TURBT." And another said, "You have this medicine in you, and you don't want to be having sex with your partner.
But once that was done, everything was back to normal." In conclusion, from the patient perspective, patients seem to agree that UGN-102 meets an unmet need in care delivery for a non-surgical treatment alternative.
Dr. Stover, thank you very much, and fascinating information and honestly, an important perspective, because why are we doing this? We're doing this to improve patient care. And speaking of patient care, we're lucky today to have a patient, Mr. Julio Lago, who has agreed to have a frank conversation with our CEO, Liz Barrett, about his experience with the treatment of non-invasive bladder cancer. So, Mr. Lago, welcome, and thank you for joining us.
... Thank you.
Thank you. Welcome, Julio.
Thank you. Thanks so much for being here. Before we get started, why don't you tell us a little bit about you and your family?
Yes, I was born in Mexico City, and I studied there. Met my wife there in college. My wife of 27 years, Jasmine. I have three girls: Fernanda, 25, and Natalia, 22, and Juliana, 13 years old. And we like to do things together. We exercise together, we run, have a very hectic life, and well, that was interrupted when this event happened, but-
Well, that's a great place to start, right? Why don't you tell us about your journey from the diagnosis, you know, to where we are today?
Yes, of course. So, my journey on this disease started in January 2020. I was running a half marathon, and at the end of it, I started to have blood in my urine. I went to the doctor. It was several days of blood, so there was suspicion that it was going to be something in my bladder, and they did some imaging, discovered a 3 centimeters tumor in my bladder. The treatment that was recommended to me at the time was doing transurethral surgery. There were some problems there because it was in the middle of the pandemic, so the-
Mm.
Hospitals were closed. There was a window that was open in April, and I was able to go there and have the surgery, right? The recovery was tough, right? There was still a lot of pain. I have problems with anesthesia, constipation, headaches, and of course, a lot of days of bleeding and discomfort in my urinary tract. But maybe 2-3 months later, I started to get a swing of things again and run again, and it all was fine until a year later. I was doing cystoscopy every 3 months, and then it recurred for the first time.
Okay. At about a year?
At about a year.
Okay.
And then, they were very small tumors, so they kind of burned them.
Yes.
Six months later, larger ones-
Mm.
So it was accelerating, and then is when the doctor offered me options, and one of the options that he offered me was to participate in this clinical trial.
Well, we're happy that you did, and thank you so much for being here. You're an engineer.
Yes.
So you mentioned being an engineer and the way you think about things, you know, played into your sort of decision to participate in this study. Tell us a little bit about your decision-making to participate in this study.
So I knew that the kind of regular treatment will take me to do another surgery—and I didn't recover very well from that one. It took me a while. It was painful. And then after that, likely, anyway, I will need to have 6 instillations of chemotherapy.
Right.
So I was not saving on the-
Right.
-on instillations. I still need to do that. And if I undertook the clinical trial, there was at least some possibility that I will not need the surgery and that it will help me more. And it from an engineering standpoint, it makes sense that if the medicine stays longer in your bladder and in the walls of your bladder, you will have a better outcome, right? So that was one of the reasons. Other thing that caught my attention, of course, was that with the treatment, you can drive yourself and go back.
Right.
You don't need anybody to help you, like, when you do the surgery. So my wife was driving me to the TURBT, and in that-
Sure
... in that way, I can save her some time as well.
No, that's great. Talk to us a little bit about you talked about your recovery from surgery and how difficult it is. Can you elaborate on that and share a little bit more about your experience after TURBT?
Yes. I remember I wake up from the anesthesia, and that was the moment that they picked to remove the catheter.
Mm.
That's what woke me up. It was, it was a pain that I have not felt, before, right?
Right.
Even through anesthesia, I was sleepy, but I woke up because of feeling it. Then I went home, and it was 7 or 8 days of doing nothing, just going from bed to restroom. It was... I never felt lack of control that I needed to be on the restroom immediately. No, 2, 3 seconds later, but there and then. I was bleeding. I was painful externally because I have scarring, because, of course, the tools go through your urethra, and there's a lot of lesions there. And then, of course, there was the headaches because of the anesthesia that last for 7 days and constipation that also lasted for 7 days. I called the doctor, and everything was in video because there was no-
All right.
You couldn't go to a clinic at that time because we're in the middle of the pandemic. Then probably 2-3 weeks later, kind of normal life, but I really didn't feel really normal in a way that I could run and do my regular activities, probably 2-3 months later.
Wow! No, it's great. Thank you for sharing. So contrast that to your experience after UGN-102 and how you felt and your ability to get back to normal days. And I do want you to share, I know that after the sixth instillation, you actually did experience some pain with UGN-102. So please, just if you could share, share some with us, that would be great.
Of course. So, again, the first instillation, I arrived there, they put a catheter on me, and it... They instill it. It was- it's a little bit cold, but that's all you feel.
Right.
Right? And then your body starts to warm it up. And then you leave home, you can walk normally, you go home, and then after a few hours, then you go pee. That first time, it was really, like, just peeing blue.
Right.
But nothing else, no pain, nothing like that, right? And then, from the second to the fifth, it was the same. The sixth one was a little bit different. I felt a lot of pain when I was peeing out, and that pain lasted a few days, two or three days. Normally, from the second to the fifth, including the first one, next day you are doing normal activity-
Right.
like nothing happened.
Mm-hmm.
So, the sixth one was a little bit painful, but nothing compared to recovery from surgery.
Well, thank you. Thank you so much for sharing your story. I just have one more question. It's been, I think, 18 months-
18, yeah, months.
Since you had UGN-102. Are you recurrence-free today?
I'm recurrent-free today. I'm running again. I have run three half marathons since I started treatment, and, well, I hope that my participation in the clinical trial allows more treatment for other people, right?
Well, we hope so, too, and thank you so much for being here. I'll turn it back over to Mark now. Mark?
Thanks, Liz. At this point in our program, we'd like to invite our audience to join us as we have a thought leader panel. We're gonna have a group discussion with some of my esteemed colleagues to talk about the data that have just been presented. Joining me today, Dr. Max Kates, who's Associate Professor of Urology and Urologic Oncology at the Brady Institute at Johns Hopkins, where he serves as the Division Director for Urologic Oncology. Dr. Jennifer Linehan, who is Associate Professor of Urology and Urologic Oncology at Saint John's Cancer Institute in Los Angeles. Dr. James McKiernan, the Lattimer Professor of Urology and the Chair of the Department of Urology at the College of Physicians and Surgeons at Columbia University here in New York.
Sandip Prasad, whom you've already heard present the data, and as I said, is Head of Genitourinary Surgical Oncology at Garden State Urology. Finally, Angela Stover, who presented her patient-centered outcomes research, will also join the panel. So with that, it's a pleasure to welcome you all today. Just a little bit of housekeeping for us and also for our folks online. Just remember that we are having a panel discussion today about an investigational agent, UGN-102, that is not yet approved by the FDA. Only the FDA decides whether a drug is efficacious and safe for use in the United States, and the application will be made later this year for this drug. So just a reminder, this is an investigational agent that we are discussing today.
Our panelists are being compensated today for their time, not their opinions, and those opinions are their own and don't reflect that of institutions with which they may be affiliated or with UroGen. So with that preamble, and a welcome to all of you, and thank you for your time, joining us this morning, I just wanna ask you for a top-line reaction. I'm gonna go right down the line and ask you, give me a sentence, one-liner, what's your response to the data you heard about today that Dr. Prasad presented?
After surgery, patients typically report some quality-of-life decrements, so the data that that Prasad had presented was pretty good news for patients, probably.
Yeah. Thanks for having us. First of all, I'll borrow a line from Dr. Belldegrun. This is a game changer, I think, in our field, to have a medical liquid treatment that's topical, that actually has results that compete with, if not beat, surgery itself is the first time we've ever seen it in bladder cancer.
I know you presented the data, Sandip, but you're in practice, too. What do you think?
No, I think the idea of chemoablation as a primary treatment for urothelial cancer. I think this study, again, reinforces this on top of the prior published data.
Angela?
I'm definitely impressed by the numbers and the durability, but most important, I have a sense of relief that I actually have something else I can offer patients.
Max?
In bladder cancer, we have always thought that first we need to resect tumors, and then we treat them with therapies to prevent a recurrence. And so to have a drug that's turning that on its head and saying, "No, no, we can treat the tumor itself without the resection," is a completely different way to treat the disease and benefits our patients immensely.
Thank you. Angela, you presented your data, talking to patients, you know, doing interviews, you know, so you have a really organic sense of how people currently feel about the investigational agent. Let's suppose UGN-102 is approved. How do you think patients will actually respond to its availability?
We asked patients this during interviews, so I appreciate the question. We particularly asked about acceptability in terms of whether they would recommend UGN-102 to other patients, and also what they themselves would choose if they had the choice in the future. All but four would recommend UGN-102 out of the 29. Two said they would not recommend because they had a non-complete response, and two were neutral because they said that they were reasoning that patients are all different, and the same was for themselves as well. So it's a marker of acceptability in future care.
Thanks. Max, I know you've studied this, and I know you're spending a lot of time lately thinking about how people think about TURBT. What's your thought about this?
Yeah, Mark, so our group has really done a lot of work to understand the burden of TURBT on our patients. We did a needs assessment of 150 of my patients in a row with TURBTs, and what we found is that urologists greatly underappreciate the burden of TURBT on our patients. And just like was presented in the data, many of these patients are going through their third, fourth, fifth TURBT, and at some point, the bladder stops tolerating it. And so our rates of admissions to the hospital were a little more than we expected. Our rates of urinary frequency and urgency and really day-to-day discomfort was more than we had appreciated.
... Yeah, it's interesting. Jen, thinking about the standard of care, which we all were brought up to think was the way to handle this disease, you know, as many have sort of acknowledged this morning, as the primary intervention. Now there's a nonsurgical alternative, but how do you think about the risk associated with that nonsurgical alternative? Clearly, it will be unfamiliar and a new paradigm, as Jim was saying, for urologists. But, is there risk at not doing surgery right away for this population?
I think the risk of not doing surgery in this population is very minimal. I mean, many of these patients, some are pushed to active surveillance if they're older or can't tolerate surgery well. It means they're gonna come back in three months, they're gonna look again. Sometimes I'm just doing fulguration in the clinic, but I've not really had the option to offer them something else besides surgery, which is chemoablation. And the risk of doing the chemoablation, many of these patients are already aware of what intravesical therapies are, coming back once a week to have something put into the bladder. So it's less scary for them. They understand what's involved in that. And the risks are gonna be just the same as a TURBT.
They can have some urgency, frequency, you know, a little bit of bleeding, but I think they're much more willing to tolerate that than having to go back to the OR time and time again.
I think it's you know, ENVISION really presents us a really nice natural history of how this disease behaves, right? We got to look at untreated low risk or intermediate risk, low-grade non-muscle invasive bladder cancer in 240 patients, and so less than 3% of patients progressed. I think that's a very robust number that we can tell patients that even if you progressed, we have the TURBT, if needed, in that, you know, almost one out of five patients who are nonresponders. Then we look at adverse events. That rate was less than 1% for severe treatment-related adverse events. So again, you have a low risk of progression to something more worrisome, and you have a very low low rate of severe adverse events.
To me, those are kind of the frontline ideas I would bring up, and again, this study allows us to finally understand these types of data in this particular patient population.
No, that, that's great, and actually leads me to my next question, which I'm gonna pose to Max. So in the sort of development arc of UGN-102, nearly 600 patients have received this drug, and Sandip has PI'd now two big studies. So there's a growing familiarity at the sort of urologist level with how this drug affects people, and there's an emerging literature on how patients experience this therapy. So assuming UGN-102 is approved by the FDA, how would you talk to a patient about making a decision between UGN-102 and TURBT?
It's a great question, Mark. You see, the average patient that walks in my room with bladder cancer for a clinical appointment is 76 years old, and they typically have multiple other medical problems. And so when I talk about an option that includes general anesthesia, half of my patients, I actually have meet with an anesthesiologist before their TURBT. And so the risks of a TURBT are twofold: talking to a patient about the risks of the procedure itself, and we're, as I said, our research program is generating some data that we can use to tell patients about the risk of things like readmissions to the hospital, and discomfort and things like that. But then there's the risk of general anesthesia, especially if you're doing it multiple times in a year. And so that's one option to talk to patients about.
You have the option of a medical therapy, and we heard some of the toxicity data, which, to be honest with you, is very in line with many intravesical therapies showing, you know, frequency and urgency and basically expected local toxicities. And so really the discussion comes down to, do you want to come into the office according to this treatment schedule? Or do we want to, you know, physically remove this oftentimes again, because remember, they've had 3 or 4 of these oftentimes before. That's generally how you talk to a patient in the clinic about this option.
Jim, what do you think? How would you, how would you explain the differences to a patient?
Yeah, it's a great question. I mean, when you look at the safety profile in the trial, if you applied those criteria to TUR as a novel investigative agent, it would come out to be far more toxic in terms of the side effects. If we don't usually do that for surgery, we don't do prospective trials and submit to the FDA to get permission to do a surgery that's been around more or less unchanged for a century. But if we did, it would not come out with a less than 1% serious adverse event rate. That we... I think everyone here as a surgeon would admit that when you think about things like bladder perforation, bleeding, urinary tract infection, wearing a catheter home, being admitted to the hospital, restarting anticoagulation, it would have a far higher morbidity profile.
Everybody who would be eligible for this drug has had an opportunity to respond to surgery, usually multiple opportunities. So in a sense, they're unresponsive to TUR. So the idea that they could have a better than 80% probability of having no cancer a year later when they've had several opportunities to do that with the standard of care and it hasn't worked, I think it'd be very easy to talk to a patient about this.
That's a great segue into my next question to you, which is: so it might be easy to talk to a patient about this. How would you talk to a doctor about this? You know, urologists are accustomed to doing the operation, and I think your paradigm, you know, the comparison of surgery as an investigational therapy is a very interesting one. But how would you convince colleagues that this makes sense?
... Yeah, that, that might be more challenging than patients, honestly, because surgeons are surgeons, just to be frank. They went into a field to help people through the practice of doing an operation, by and large. Our field's a little bit unique in that we have multiple medical therapies. I think if you look at healthcare in general, the evolution of advances has been more in systemic, targeted, and minimally invasive things. So a surgeon that doesn't adapt to that, I think, is at risk of being left behind. So if you said, "Look, I just want to operate, I'm going to ignore this data," eventually it's going to catch up, and people are going to demand it and ask for it, just like they do with focal therapy or targeted therapy or genomic-based therapy.
There'll be some resistance at the outset, I'm sure, but I think the thinking person who's in this field is going to say, "Wow, this is really amazing, and I want to be a part of this." And they'll probably select certain patients, patients who've had complications with surgery, older patients, and then get more comfortable with the technology as time goes on.
I don't mean to beat up on Max, but I know you've sort of looked at doctor attitudes towards surgery. You want to comment on this at all?
Yeah. I mean, I think that generally speaking, I would agree. You know, we are part of a, I'll say, a Halstedian creed, right? So the whole timeline of surgery is usually pulling back and seeing where we can use surgery to maximally benefit our patients. And I think those urologists that treat this disease very often have a full understanding that a TURBT for a low-grade, non-invasive lesion is maybe not going to be the most durable, effective therapy for their patient, if they're being honest with themselves. So I... You know, that's, that's how I view that.
Yeah. Thanks. So, Sandip, when you think about where this could potentially be used in practice, if it's approved, where would you see it being used first? Are there special populations of patients who might be the most logical to treat initially? How would you, how would you envision that rolling out?
So, so with a complete response rate of over 79%, to me, every patient should be offered this therapy as their first-line option for their intermediate-risk disease. As Dr. McKiernan mentioned, these are patients that have failed our primary paradigm. And so offering them a high complete initial response and a very durable response that I think exceeds surgery in all of our hands, especially in this patient population of recurrence, to me, this is sort of front line. Where do I think in practice urologists will use this? We have many of our patients, as Max alluded to earlier, that have cardiopulmonary disease. These are patients we don't like to take to the operating room. We worry about these patients with general anesthesia. That's an easy place to start. We have patients who are on systemic blood thinners. Again, many of these patients are former smokers.
They have cardiac disease. We have to pause those blood thinners to do the operation. Those patients are at risk for heart attack and stroke when we do that, and risk for bleeding subsequently when they restart their blood thinners. So there are a lot of patients that are potentially the easiest ones to begin with. But again, with the data being as compelling as I believe they are, the entire population of low-risk patients, I think, are appropriate. I think Julio, our patient, really mentioned something very important, which is that for this patient population, I typically will give these patients six treatments of chemotherapy after their TURBT because they have failed at primary paradigm. I give them follow-up treatment six times in a row. This is the same treatment to a patient.
It's coming in once a week for six weeks for a catheter, but you may be able to skip the TURBT. That, I think, when you have that type of conversation with these higher-risk, recurrent patients, with low-grade disease, to me, it's, there's really not a population we shouldn't offer this to.
Interesting. Jen, what do you think? Any, any special groups? Any special comments?
No, I agree that we should offer all patients that are diagnosed with low grade this as a first-line treatment option. In my clinic, I mean, when COVID happened, we lost about 15% of the urologic workforce. And so getting in to do a TURBT in my clinic can take up to six weeks, where I can actually offer the patient to come in, get treatment that has better recurrence rates than the TURBT, starting the following week. So I think that's a very important fact for me.
Interesting. Well, it sounds like everybody has a fairly positive response to the data. I know we're coming up on the end of our time for the discussion, but what have I forgotten to ask you? Any burning comments that you'd like to offer at this point in the conversation?
I'll pick up on, on Jennifer's comment. Access to physicians in the United States, 70% of counties in America don't have a urologist, 70. So the idea of access to TUR versus access to a medical therapy that could be provided by a non-physician or non-surgeon is a huge sort of access to care national issue. And I think if this is approved, it's going to fit in some of those areas where there just isn't access to the operation. Even if the surgeon wants to do it, they're not there to do it oftentimes.
Interesting. Well... Yes, sorry, Angela.
Shared decision-making is probably going to become a big deal in the future, and there are other cancer types that we can draw from, for how to talk to patients about this, how to talk to urologists about this, for instance. So I think we should draw on, other literature in, in that regard for how we present it to patients and, manage their expectations.
I want to thank everybody for joining us. We're now going to turn to a Q&A moderated by our CEO. I want to welcome Liz Barrett back up to the podium. Once again, thank you for your time and your comments. Very much appreciated.
Thank you, and hang tight. We have a couple of slides that we're just going to summarize with, and then we'll go to Q&A. So what is next? I'd never get tired of looking at this slide and repeating these numbers. And I know Dr. Prasad did a couple of times, and I'm going to. 79.6% complete response rate, 82.3% duration of response at 12 months. It really is unprecedented in this space. So our timing now, now that we see where we are today with the ENVISION results, we will be working to complete the submission. We have talked about submitting in September, so Q3 of this year. We will be asking for priority review, so we'll find out obviously when they accept it. We actually have already started our submission.
We started in January with a rolling NDA. If we get priority review, the potential approval will be in Q1 of 2025, and a standard review would take us to Q2 of 2025. Again, just wanna reiterate the unique position that we're in as a company. First drug, first medicine to be approved in this patient population, over 80,000 addressable patients, a large market, but more importantly, the impact that we can have on patients. And I can't say enough about the stuff that Angela shared, and over 86% of the patients preferred and would refer other patients to getting this medicine. So with that, I will open it up to Q&A and the analyst, and I know we're working here, so.
Thank you, Liz. At this time, we'll begin conducting our Q&A session. As a reminder to the analysts on the call, please raise your hand to indicate you would like to join the queue. So with that, we'll take our first question from Ram Selvaraju at H.C. Wainwright. Please go ahead, unmute, Ram.
Thank you. Can you hear me?
Yes, we can. Thank you, Ram.
First of all, congratulations on this excellent and landmark data. I think it's a very important step forward for patients. But I was wondering if perhaps both the company and the panel could opine on this. You know, what specifically might be drivers of early positioning of this therapy ahead of TURBT in the low-grade intermediate-risk population? And then I'm talking specifically from the physician's standpoint. What specific attributes of this therapy are physicians most likely to take into account when considering the possibility of using this ahead of TURBT?
Yeah, great, great question, Ram. So anyone from the panel wanna take a shot, share their thoughts? Go ahead, please.
Yeah, I think we touched on it earlier. Physicians who have operated on the same patient multiple times, and I'll give you an instance. Yesterday, I operated on 3 patients who had each had over 12 TURs by me in the past 10 years, experiencing various complications along the way. When you sit down and talk to them, this isn't currently an option, so your options are essentially to do it again and again and again and expect a different result. I think that's where this is gonna start, and the physicians are gonna actually look to use it there just to change what they're doing, and that's not working. And then it'll eventually spread to people who perhaps had one previous TUR that went very well and worked, but they just don't wanna do it again.
Right.
I think we recognize that white light cystoscopy in TURBT, which is what the vast majority of urologists perform, has limitations. We know that there are some technologies that are not available universally, with enhanced technologies, can allow us to do a better job with resection. So I think we recognize, as urologists, that TURBT is somewhat imperfect. I think that many of the recurrences we likely see may be very small tumors we can't identify the first time. And so again, for patients who are multifocal, where they've demonstrated multiple tumors throughout the bladder, or recurrent patients where perhaps we can't see those tumors primarily, the one benefit of a treatment like this is it's sort of agnostic to where the tumors are. The gel goes everywhere and coats the entire surface of the bladder, and so it's going to treat whatever you see.
I think, as Dr. McKiernan mentioned, you'll get a gestalt as a urologist of, is this a patient where TURBT itself is just not the primary driver of getting this patient to a durable response? And I think that's different for every urologist, but I think we acknowledge already in our own practices that we have limitations with TURBT.
That's great. Thank you. Thanks, Ram. Next.
Thank you for the questions, Ram. The next question comes from Tara Bancroft at TD Cowen.
Hi, thanks for taking the question. For the company, considering these fantastic data, now, what is your level of confidence that you will receive priority versus standard review? And then for the KOL panel, curious to hear what percentage of your patients would you use this in, either initially and over time or both?
Great question. Tara, if I knew the answer to that question, I think I'd be out, playing the ponies or something. But anyway, we feel really good and very confident in our data package, particularly given the compelling nature of the data that we've shown, not just today, but last year as well, and ATLAS will be a supportive study. So we think given what you've heard today, given the fact that there are no other treatments for these patients, and given the fact that we have such compelling data, we feel very confident that we'll be able to get priority review. So with that, I'll ask the panel to answer your second question: So what percentage of your patients do you think you would use this in?
Yeah, so the majority of my patients meet the intermediate risk category by having repeated tumors. So the conversation would start in the vast majority to say, "We can do a TURBT again or try this." So I would say, you know, close to all would have the conversation. Now, how many would I say, "I think, this is what you should be doing?" I would say at least half, because remember, I'm concerned about general anesthesia. I can't stress this enough. Many of my patients are frail, and I worry about, surgery in them. So that's how I would answer that question.
Okay, great. Thank you. Dr. Linehan?
So I'm gonna tell you who I, you know, would not use this in, and that's a very, very small percent of my patient population. The patients who are, you know, actively having bleeding or may need an urgent surgical intervention, which is a very low number in this group, are probably the patients I'm not gonna use it on. But everyone else, even patients that I've now just diagnosed in the clinic, I think are good candidates for this drug.
Thank you. So next. Thank you, Tara.
The next question comes from Leland Gershell at Oppenheimer.
Hi, Leland.
Hi, good morning, and my congratulations as well, and thank you for holding this, and to all the discussions for this, great review. So a couple questions from us. I wanted to ask, you know, in those cases where patients may have an initial CR, and then at some point in time they fall off and, you know, go out of complete response, what would be your outlook on reinduction with 102 in those patients? And then also wanted to ask, I think Dr. McKiernan, you mentioned that, you know, that sort of a lack of even coverage of urologists and urology surgical expertise across the U.S.
Just wanted to delve a little bit further into how you to the extent of which you could see 102, you know, really just expanding kind of the appropriate treatment of patients with low-grade NMIBC. The first dose, I believe, has to be given by a urologist, but I think in the subsequent doses, they can be given by somebody who's not necessarily an MD. So I just wanted to ask if you could spend another couple of minutes just discussing how that might expand the treatment of NMIBC. Thank you.
Great. Thank you. Dr. McKiernan, if you want to start?
Yeah. I mean, it would mostly be through advanced practice providers, would be my assumption. You know, making the diagnosis of intermediate-risk disease will require a urologist. I don't want to make the idea that we could just simply be, you know, treating patients without a urologist anywhere in the region.
Right.
But the idea that someone waits a long time for a cystoscopy, a surveillance cystoscopy, or a diagnostic TUR, and then has the ability to have this therapy done without a doctor in the region. Maybe that doctor's there intermittently, travels to that area, but someone else, another healthcare provider, and maybe not a urologist, but an MD of another type, could potentially be the person providing it. I don't want to get voted out of the American Urological Association. But it's possible this medication could be given by another type of doctor or a nurse practitioner.
We do need more urologists. I think we all-
Yeah.
Do know that. What about the retreatment question?
Yeah, I have no experience. I will say that I wasn't involved in this trial, so I won't speculate on that, but I can't see a reason why it couldn't be used a second time. I'm gonna guess the company has no data to support that use.
Not yet, but that's something we'll be looking for.
Most patients, I think, who have a recurrence after this would likely opt for a TUR, one, to reestablish histologic diagnosis and sort of reset things. But, I would imagine that just like we use many other intravesical therapies more than once, BCG, liquid mitomycin-
Sure.
and gemcitabine are used serially in the same patient.
And agree, and that's absolutely something we'll want to study, you know, either through a registry or in a clinical study or anything. Anybody else have any comments about retreatment specifically?
Yeah, I think it depends a bit on the timing of the recurrence.
How long, right?
Right. So I think, as Dr. McKiernan said, if a patient either failed or recurred within three months, I think I would also be concerned. There has to be... There's only 3%, but that, that's a real number of progression. And I think for patients where you have concern for high-grade disease, certainly a TURBT remains a standard of care and the appropriate next step. I think if a patient has a 40-month duration of response and then recurs with a single papillary lesion, that I think many urologists feel comfortable that that's something that we can address and qualify as low-grade, especially in the history of a prior low-grade diagnosis. I think offering that patient initial retreatment and then again, a re-resection if you're in that 20% that fail, I think is sort of an appropriate strategy.
Right.
So again, the timing of the recurrence probably is important.
Yeah, I agree with you there. Thank you.
Thank you. The next question comes from Paul Choi at Goldman Sachs.
Thank you. Good afternoon, my congratulations to Arie, Liz, and Mark on the great data.
Thank you, Paul.
My first question, maybe to the panel is, as you think about the treatment setting where you might, you know, initially use UGN-102 as well as over the longer term, do you envision it being primarily, let's say, in hospitals or ambulatory centers... Outpatient centers, excuse me, versus the office? And maybe just, you know, how do you see that evolving over time? And my second question to the panel is, you know, how do you think about potential use of 102 in the neoadjuvant setting, given similar chemotherapies are used in that particular setting? Just what are your thoughts on potential neoadjuvant use would be here. Thank you.
That's great. Anybody? Max, maybe.
Yeah, in terms of where it's given, you know, I would just... So the beauty of this is that many urologists, most urologists have intravesical therapy programs already that are very active. At my center, we have three nurses, that's literally all they do is intravesical therapy. And so in the clinic would be, you know, where you would do this, and those nurses and the people well trained to do that would do it. The next part of your question was about this idea of neoadjuvant therapy.
Right.
So, that's basically what this is. So, we think about therapies as being in the adjuvant setting, which would be after resection of a tumor, or in the neoadjuvant setting, which is basically the same as ablation, so before you would do surgery, and that's exactly what this is. So this, this is kind of taking a page from, say, in muscle-invasive bladder cancer, where we give systemic chemotherapy before we take out somebody's bladder and do a cystectomy. This is that same paradigm, just in the earlier stage of disease. So in terms of how urologists think about this, yes, currently, we don't do ablative or neoadjuvant therapy for non-muscle invasive bladder cancer in this way, but we already do it for other stages of bladder cancer.
... So I think in that way, it's the paradigm exists already in this disease space.
But neoadjuvant, to me, means that you're gonna be doing something after you give it. The whole point of using UGN-102 is that I don't have to do anything after I give it. I don't have to do another surgery.
Great point.
So, so I shared this with the panel, before this, this entire program began. So I had a patient on study, this is a patient who was a veteran, a Vietnam veteran. And this patient had an incredible number of tumors at every TURBT. I think all of us have this type of patient, maybe 30, 40, 50 papillary tumors. And over the course of maybe 6 to 8 TURBTs over the past couple of years, I've never, ever cleared this patient.
Wow.
My goal was to try to get them down, and we call it triage, where we try to get it down 60% or 70%. You're bleeding, and we stopped it. So I put this patient fairly, unfairly on study. And this patient, when I looked back in, went from 40-50 tumors down to 3, and they were all clustered in one location. I'll always wonder if perhaps maybe the gel didn't reach that location. That patient is actually a failure. That patient did not have a complete response.
Okay.
I then resected that patient, and now, well over a year, he has been disease-free on every cystoscopy. So, you know, again, that to me is maybe the new neoadjuvant paradigm, and I think every urologist has that patient that we cannot surgically resect. The anatomy is too complicated, the recurrence rates are too high. And I don't know if that's the paradigm, but again, I, I think that that's a patient where it really was neoadjuvant-
Yeah
... therapy. And the surgical resection then allowed for, you know, what appears to be a durable, curative response, so. Again, in this study, that patient was one of our failures.
That's right. Which is a little bit scary, right? The partial responders. We'll have to talk about that and how we study partial responders in the future. But thank you. And thanks, Leland.
I think we have one more analyst in the queue, which will be Matt Kaplan from Ladenburg Thalmann.
Sorry, that was... Thanks, Paul. Sorry. Matt?
Good afternoon, thanks for taking the questions, and congrats on the outstanding results.
Thank you.
I guess maybe just first, Liz, just one more point of speculation on your point. What's your sense in terms of the probability of an advisory committee meeting for this NDA?
Yeah, as we've communicated many times, the FDA, and in their written comments, have said we are likely to have an ODAC. Now, we also were told that with Jelmyto, we didn't have an ODAC. But I do think that when the FDA characterized why they felt strongly that they would need an ODAC, they said, much of what you've heard today, this is paradigm shifting. So this is changing the way physicians practice. So because of that, we're gonna want to get feedback from key stakeholders. So I would say we're more likely than not to have an ODAC. We've already started our preparations. We're ready for that. Frankly, we welcome that because we believe that the data that we've shown are very compelling, and we believe that the key stakeholders are anxiously awaiting a new, a new way to treat these patients.
But, it's a great question, Matt.
Then, maybe a second question for both you and the panel. In terms of what you see as the hurdles for adoption, I guess, of this therapy, whether it's in your practices or other practices, and then maybe a little bit about the educational hurdle to convince docs and patients to utilize UGN-102.
Well, actually, I'd love to hear from the panel, myself as well. What do you think are the biggest hurdle? Maybe if each of you could sort of, you know, just share what you think the biggest hurdle of physicians adopting UGN-102.
I'll start. So, if you think about high risk, like BCG unresponsive, non-muscle invasive bladder cancer, that's an area that is a commonly referred disease, likely to urologic oncologists, oftentimes, people that treat a lot of bladder cancer. This is such a common disease entity that we're talking about today, low-grade non-muscle invasive bladder cancer. Basically, every urologist in the United States treats this and treats this often. And so I see the biggest barrier as there's a larger pool of urologists that would potentially be using this, and there's a lot more education that would need to happen, as compared to some of these more sort of niche, unresponsive bladder cancer groups.
Great.
I think for me, so I had experience with gemcitabine, which is what we use for upper tract, and one of the barriers to that was logistically, sometimes getting the drug in the clinic or having someone make the drug is sometimes a barrier for urologists to get it. But I think the concept of the chemoablation and the concept of intravesical therapy is so well known that I don't think that's gonna be a barrier. It's gonna be something logistical.
Okay, great. Thanks. Dr. Sandip?
I think TURBT is probably one of the most meaningful operations that we do as urologists. I think that we feel a great degree of closure at the end of a procedure when there's a tumor at the beginning and there's no tumor at the end. But I think more importantly-
Instant gratification.
Right. It is. And we do it tangibly. And so I think in the end, the data are strong enough that I think for patients, we get a response that's better. But I think for many urologists, this will be a complete change in the way in which we practice. And I think as Max pointed out, this is applicable. I'm a community-based urologist. Everybody treats this disease space. And so I think it just takes time, but again, the data are strong, and that is really what supports the case for the use.
Great. Thank you.
Yeah, I'd pick up on that and say the strength of the data is probably gonna be the biggest challenge because most data that comes out in this field or any field is incremental. So this drug is 5% better than that drug, or this treatment is a little bit longer duration than that treatment. This is a drug against a long-standing surgery. That's, those two things have never been compared before, let alone compared, and the results being this impressive. So people are gonna have a hard time processing that. If you're sitting with a doctor trying to explain this, they're not gonna understand what you're even talking about for the first couple of minutes, and then ask you to go back to the previous slide and say, "Wait, what did you... What study did you run?
What happened?" And then they're gonna be like, "Oh, my God," moment. Like, "What? What just happened here?" And then you're gonna have to come back and explain it to them again, like, a few days later.
Right. Angela, I don't know if you have any thoughts about physicians and patients?
Sure. I'm an implementation scientist, and what that means is that we take what is found in trials and research, and we try to put them into practice. So that's our entire field, is how to do that. So I think there's a field that we can look to and a lot of precedent, actually, in urology for prostate cancer, et cetera, for shared decision-making.
Thank you. I agree with you. I do think it's, you know, being able to help and facilitate that discussion between the physician and the patient will be very, very important. Anything else?
That concludes the Q&A session. I'll turn it back to you, Liz.
Great. And thank you. Just wanna say thank you to everybody for joining us. We really appreciate and look forward to keeping you posted as, as things pan out. So thank you. Thank you very much.