What Everyone’s Talking About: Highlights from SUO 2024 - Amy Luckenbaugh
February 8, 2025
Amy Luckenbaugh joins Sam Chang to discuss highlights from SUO 2024, focusing on two significant late-breaking trials in non-muscle invasive bladder cancer. She examines a study combining intravesical gemcitabine with BCG for BCG-exposed patients, which shows promising complete response rates, and reviews results from a phase III trial of cretostimogene in BCG-unresponsive disease with carcinoma in situ. The discussion explores practical considerations in treatment selection, including the balance between pursuing bladder-sparing options and proceeding to cystectomy. Dr. Luckenbaugh emphasizes the importance of considering patient factors such as tumor volume, travel distance, and urinary symptoms when selecting therapies, while highlighting her preference for clinical trials to preserve future treatment options. Throughout, she addresses the expanding array of treatment choices now available for managing non-muscle invasive disease.
Biographies:
Amy Luckenbaugh, MD, FACS, Assistant Professor, Department of Urology, Division of Urologic Oncology, Vanderbilt University Medical Center, Nashville, TN
Sam S. Chang, MD, MBA, Urologist, Patricia and Rodes Hart Professor of Urologic Surgery, Vanderbilt University Medical Center, Chief Surgical Officer, Vanderbilt-Ingram Cancer Center Nashville, TN
Biographies:
Amy Luckenbaugh, MD, FACS, Assistant Professor, Department of Urology, Division of Urologic Oncology, Vanderbilt University Medical Center, Nashville, TN
Sam S. Chang, MD, MBA, Urologist, Patricia and Rodes Hart Professor of Urologic Surgery, Vanderbilt University Medical Center, Chief Surgical Officer, Vanderbilt-Ingram Cancer Center Nashville, TN
Read the Full Video Transcript
Sam Chang: Hi, my name is Sam Chang. I'm a urologist at Vanderbilt University in Nashville, Tennessee, and I have lots of things to be thankful for in the past, as well as in 2025, but I cannot say I’m more thankful than having a partner as great a person as Dr. Amy Luckenbaugh.
Dr. Luckenbaugh is actually the past chair of the SUO 2024 meeting, and she's been kind enough to actually give us some of the highlights from her chair's perspective, looking at the so many innovations and so many great findings we found out on urothelial carcinoma—kind of trends with diagnostics and therapeutics.
And so we asked Dr. Luckenbaugh to actually give us her point of view on what people are talking about when it came to the highlights of the SUO 2024. So, Amy, thanks so much for spending some time with us, and we look forward to your presentation.
Amy Luckenbaugh: Thank you so much for having me. The introduction was far too kind, and I'm lucky to have Dr. Chang as a partner. And so as the chair of the SUO meeting, everyone may have noticed it was heavy in the urothelial world because there’s so many exciting things going on in the urothelial world right now. So I have elected to just talk about the two late-breaking abstracts, both in similar and non-muscle invasive bladder cancer, but a little different disease space.
So the first was a trial that was out of Memorial Sloan Kettering that looked at actually combining intravesical gemcitabine and BCG for patients with BCG-exposed but not refractory and not unresponsive non-muscle invasive bladder cancer. And they put patients who had had prior high-grade Ta, T1 carcinoma in situ and had a response with BCG, and that BCG had to have been received within 24 months prior. And their primary endpoint was those who had a complete response at six months.
The schedule was quite intensive. Patients received gemcitabine twice weekly for a span of four weeks, and BCG weekly for a span of six weeks, and then if they responded, they went on to receive normal maintenance BCG. And just to show the schedule schematically from their talk, you can see the gemcitabine was given twice weekly at weeks 1, 4, 7, and 10. And the BCG was given the opposite weeks.
So they had really, really great results. Their complete response at six months was 94%, which is pretty great, especially in this population. And then it was sustained at 12 months in 81% of patients, a complete response. And if you look specifically in those who had CIS with or without high-grade Ta and T1, they had a 97% complete response rate, so really impressive results.
I think the things that are exciting about this is that it was really efficacious, even out to 12 months. It was really well-tolerated. And we know both of these medications are easily available and readily available to community urologists, to academic urologists, and it is fairly cost-effective compared to some of the newer medications. I think the big question for me is that scheduling burden for patients to do something twice a week as well as weekly—it is a lot for many patients. But they will be enrolling in the phase III trial comparing gemcitabine plus BCG to BCG alone, which I think will have exciting outcomes.
Shifting gears. I want to make sure to specify this trial is for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. So a little bit different of a space. And this was a phase III trial of cretostimogene. And they enrolled patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer who had carcinoma in situ with or without high-grade Ta and T1, and their primary endpoint was a complete response at any time. And their schedule is very similar to BCG, so given in a way that providers are very familiar with—weekly for six weeks—and then maintenance was given if they responded every three months for a year and every six months for two years. If you did not have a complete response at that first induction course, you were eligible to get a second induction course consistent with BCG-refractory disease.
And in this trial, again in a BCG-unresponsive population, they had really good results, with a complete response rate of 74% at any time, and at 12 months, about a 46% complete response rate. What I think is exciting for patients is that 90% of patients had a cystectomy-free survival at 12 months, so had not received a cystectomy, and 97% had no progression to muscle invasive disease at that year mark.
And for those who did respond, their duration of response was at least 27 months. At the time of the presentation, it had not yet been reached. This was also very well tolerated with no grade 3 or higher treatment-related adverse events and no terminations because of side effects, so this is a great option—one of the many great options that are coming out for patients with non-muscle invasive bladder cancer that is BCG-unresponsive.
And it is, again, an excellent complete response for BCG-unresponsive patients. It was well-tolerated, and they have a great sustained duration of response that was a very similar administration schedule to BCG, so it’s going to be easy for people to administer without too much new burden on how to administer it.
Sam Chang: Amy, thanks first of all for calling me Sam during this presentation. I think it’ll be really important as we continue this dialogue. As you look at all the different treatment options that are out there for either BCG-exposed or BCG-unresponsive types of carcinoma, it looks like cystectomy is being pushed further, further, further down the line of treatment options.
Tell me in your practice, who are the patients that you really seriously consider for these trials, as we are obviously concerned about progression of disease, but want them to have possible therapies that could avoid cystectomy, versus those who you think maybe should go ahead and proceed to cystectomy? Tell me what you think about as you make that decision.
Amy Luckenbaugh: Yeah, I think we all see the patients who get BCG, and you look in their bladder, and it looks a lot better than it did before they received BCG. They may have one or two little spots. It doesn’t look like it’s high, high volume. And those are patients that I feel pretty good about putting on a trial or trying to do this.
But patients who’ve received adequate BCG, and I look in and the tumor volume is worse, I always worry a little bit about putting on trials like this. And if tumor volume is increasing with any intravesical therapy, that’s usually a bad sign. I’m not enthused about people with variant histology and really high volume, high-grade T1 that I feel like just keeps coming back, and it’s worse each time. Those are patients I tend to not encourage to do this.
But a lot of patients don’t fall into that category and fall into the category of a solitary recurrence, or it got a little better, or they had an initial—like, they didn’t recur within that first six-week induction course and three-week maybe. And so it was a little bit after that. Those patients I feel pretty good about encouraging to try other options. And then, of course, the patients who may be too unhealthy, who we try to putts down the road or putter along as long as we possibly can.
Sam Chang: And as you consider all these different trials and their different mechanisms of action, different delivery systems—the credo with the pretreatment saponification kind of action, you’ve got the pretzel with the gemcitabine in it, you’ve got viral therapies, you have all these different types of modalities. As you think about these different treatment options, ultimately, obviously, I think people will say efficacy will be the most important thing, how people respond. What else is really important to you and your patients as you try to decide the best treatments for them?
Amy Luckenbaugh: I think that obviously efficacy, but it seems like everything is falling within this 5% to 10% range of efficacy. And so other things that I think are important is whether they have bad lower urinary tract symptoms that may not tolerate a device being in their bladder or something like that, whether they have to travel a really far distance, in which case a weekly treatment or, in some cases, a twice-weekly treatment is not as convenient for them.
And something like Adstiladrin, where you’re getting it monthly every three months, is much more convenient, or a pretzel, in that case, might be more convenient because of the every-three-week change out. So I think about what their job is, how far they travel, and how flexible they are in their scheduling, and what their lower urinary tract symptoms are to begin with. I think that plays a role in the decision-making.
Sam Chang: So I’m not going to put you on the spot, but as you look at these treatment choices that are out there, is there one that you tend to—do you recommend trials versus those that are currently available now?
Amy Luckenbaugh: So I first tend to recommend trials because I tell patients if you go on a trial and it doesn’t work, I can then go to the things that are available now, whereas, oftentimes, if you’ve received Adstiladrin or Gem/Doce, you may be excluded from trials. And so I don’t tend to do those first unless there’s a reason that they’re excluded from a trial. I tend to try to push a trial first, give them as many options as they can have before going forward to cystectomy.
Sam Chang: Well, Dr. Luckenbaugh, thank you so much. We appreciate your time and your expertise, and we look forward to having you on UroToday again soon.
Amy Luckenbaugh: Thank you, Dr. Chang.
Sam Chang: Hi, my name is Sam Chang. I'm a urologist at Vanderbilt University in Nashville, Tennessee, and I have lots of things to be thankful for in the past, as well as in 2025, but I cannot say I’m more thankful than having a partner as great a person as Dr. Amy Luckenbaugh.
Dr. Luckenbaugh is actually the past chair of the SUO 2024 meeting, and she's been kind enough to actually give us some of the highlights from her chair's perspective, looking at the so many innovations and so many great findings we found out on urothelial carcinoma—kind of trends with diagnostics and therapeutics.
And so we asked Dr. Luckenbaugh to actually give us her point of view on what people are talking about when it came to the highlights of the SUO 2024. So, Amy, thanks so much for spending some time with us, and we look forward to your presentation.
Amy Luckenbaugh: Thank you so much for having me. The introduction was far too kind, and I'm lucky to have Dr. Chang as a partner. And so as the chair of the SUO meeting, everyone may have noticed it was heavy in the urothelial world because there’s so many exciting things going on in the urothelial world right now. So I have elected to just talk about the two late-breaking abstracts, both in similar and non-muscle invasive bladder cancer, but a little different disease space.
So the first was a trial that was out of Memorial Sloan Kettering that looked at actually combining intravesical gemcitabine and BCG for patients with BCG-exposed but not refractory and not unresponsive non-muscle invasive bladder cancer. And they put patients who had had prior high-grade Ta, T1 carcinoma in situ and had a response with BCG, and that BCG had to have been received within 24 months prior. And their primary endpoint was those who had a complete response at six months.
The schedule was quite intensive. Patients received gemcitabine twice weekly for a span of four weeks, and BCG weekly for a span of six weeks, and then if they responded, they went on to receive normal maintenance BCG. And just to show the schedule schematically from their talk, you can see the gemcitabine was given twice weekly at weeks 1, 4, 7, and 10. And the BCG was given the opposite weeks.
So they had really, really great results. Their complete response at six months was 94%, which is pretty great, especially in this population. And then it was sustained at 12 months in 81% of patients, a complete response. And if you look specifically in those who had CIS with or without high-grade Ta and T1, they had a 97% complete response rate, so really impressive results.
I think the things that are exciting about this is that it was really efficacious, even out to 12 months. It was really well-tolerated. And we know both of these medications are easily available and readily available to community urologists, to academic urologists, and it is fairly cost-effective compared to some of the newer medications. I think the big question for me is that scheduling burden for patients to do something twice a week as well as weekly—it is a lot for many patients. But they will be enrolling in the phase III trial comparing gemcitabine plus BCG to BCG alone, which I think will have exciting outcomes.
Shifting gears. I want to make sure to specify this trial is for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. So a little bit different of a space. And this was a phase III trial of cretostimogene. And they enrolled patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer who had carcinoma in situ with or without high-grade Ta and T1, and their primary endpoint was a complete response at any time. And their schedule is very similar to BCG, so given in a way that providers are very familiar with—weekly for six weeks—and then maintenance was given if they responded every three months for a year and every six months for two years. If you did not have a complete response at that first induction course, you were eligible to get a second induction course consistent with BCG-refractory disease.
And in this trial, again in a BCG-unresponsive population, they had really good results, with a complete response rate of 74% at any time, and at 12 months, about a 46% complete response rate. What I think is exciting for patients is that 90% of patients had a cystectomy-free survival at 12 months, so had not received a cystectomy, and 97% had no progression to muscle invasive disease at that year mark.
And for those who did respond, their duration of response was at least 27 months. At the time of the presentation, it had not yet been reached. This was also very well tolerated with no grade 3 or higher treatment-related adverse events and no terminations because of side effects, so this is a great option—one of the many great options that are coming out for patients with non-muscle invasive bladder cancer that is BCG-unresponsive.
And it is, again, an excellent complete response for BCG-unresponsive patients. It was well-tolerated, and they have a great sustained duration of response that was a very similar administration schedule to BCG, so it’s going to be easy for people to administer without too much new burden on how to administer it.
Sam Chang: Amy, thanks first of all for calling me Sam during this presentation. I think it’ll be really important as we continue this dialogue. As you look at all the different treatment options that are out there for either BCG-exposed or BCG-unresponsive types of carcinoma, it looks like cystectomy is being pushed further, further, further down the line of treatment options.
Tell me in your practice, who are the patients that you really seriously consider for these trials, as we are obviously concerned about progression of disease, but want them to have possible therapies that could avoid cystectomy, versus those who you think maybe should go ahead and proceed to cystectomy? Tell me what you think about as you make that decision.
Amy Luckenbaugh: Yeah, I think we all see the patients who get BCG, and you look in their bladder, and it looks a lot better than it did before they received BCG. They may have one or two little spots. It doesn’t look like it’s high, high volume. And those are patients that I feel pretty good about putting on a trial or trying to do this.
But patients who’ve received adequate BCG, and I look in and the tumor volume is worse, I always worry a little bit about putting on trials like this. And if tumor volume is increasing with any intravesical therapy, that’s usually a bad sign. I’m not enthused about people with variant histology and really high volume, high-grade T1 that I feel like just keeps coming back, and it’s worse each time. Those are patients I tend to not encourage to do this.
But a lot of patients don’t fall into that category and fall into the category of a solitary recurrence, or it got a little better, or they had an initial—like, they didn’t recur within that first six-week induction course and three-week maybe. And so it was a little bit after that. Those patients I feel pretty good about encouraging to try other options. And then, of course, the patients who may be too unhealthy, who we try to putts down the road or putter along as long as we possibly can.
Sam Chang: And as you consider all these different trials and their different mechanisms of action, different delivery systems—the credo with the pretreatment saponification kind of action, you’ve got the pretzel with the gemcitabine in it, you’ve got viral therapies, you have all these different types of modalities. As you think about these different treatment options, ultimately, obviously, I think people will say efficacy will be the most important thing, how people respond. What else is really important to you and your patients as you try to decide the best treatments for them?
Amy Luckenbaugh: I think that obviously efficacy, but it seems like everything is falling within this 5% to 10% range of efficacy. And so other things that I think are important is whether they have bad lower urinary tract symptoms that may not tolerate a device being in their bladder or something like that, whether they have to travel a really far distance, in which case a weekly treatment or, in some cases, a twice-weekly treatment is not as convenient for them.
And something like Adstiladrin, where you’re getting it monthly every three months, is much more convenient, or a pretzel, in that case, might be more convenient because of the every-three-week change out. So I think about what their job is, how far they travel, and how flexible they are in their scheduling, and what their lower urinary tract symptoms are to begin with. I think that plays a role in the decision-making.
Sam Chang: So I’m not going to put you on the spot, but as you look at these treatment choices that are out there, is there one that you tend to—do you recommend trials versus those that are currently available now?
Amy Luckenbaugh: So I first tend to recommend trials because I tell patients if you go on a trial and it doesn’t work, I can then go to the things that are available now, whereas, oftentimes, if you’ve received Adstiladrin or Gem/Doce, you may be excluded from trials. And so I don’t tend to do those first unless there’s a reason that they’re excluded from a trial. I tend to try to push a trial first, give them as many options as they can have before going forward to cystectomy.
Sam Chang: Well, Dr. Luckenbaugh, thank you so much. We appreciate your time and your expertise, and we look forward to having you on UroToday again soon.
Amy Luckenbaugh: Thank you, Dr. Chang.