Episode 49: Bladder Cancer Updates From ASCO GU 2026

Dr. Andrea Apolo from the NCI and the co-Chair of the ASCO GU 2026 scientific program joined the Healthcare Unfiltered EXPRESS to share what she viewed as potentially practice-changing data in bladder cancer. She discussed what she viewed as the top 4 abstracts to be aware of.

Stay up to date on all oncology meetings by subscribing to Healthcare Unfiltered EXPRESS; share with colleagues, and join the conversation.

Transcript

SPEAKER_00 0:01

Welcome to the Healthcare Unfiltered Express, where I conduct short video interviews packed with relevant and timely information that you cannot miss. So sit back and enjoy the show. What couldn't be happier than Dr. Andrea Polo is back with me on the show on Healthcare on Filter Express. Thank you, Andrea, for coming on the show.

SPEAKER_01 0:27

Thanks for having me.

SPEAKER_00 0:28

And congratulations on an amazing ASCO GU. You you chaired the meeting, uh uh you co-chaired the meeting, but congratulations. Flawlessly executed and a lot of fun.

SPEAKER_01 0:39

Yeah, it was a lot of work, but it was really very rewarding, a labor of love, and I felt very privileged to be part of the team that really put the meeting together.

SPEAKER_00 0:52

Now, with that, uh, we thought we'll just do a quick episode just to update folks on data from bladder cancer, urothelial cancer, that really intrigued you, obviously, but more importantly has practical implications. And I think before we started tipping, you suggested maybe four abstracts or four data points you want to talk about.

SPEAKER_01 1:10

Uh yeah, so I wanted to start off with kind of the star of the show, which was the EB304 data or keynote B15 data. Um, because I really think that if there was a plenary session, this would have been in the plenary because it it it it changed, it will change the standard of care for bladder cancer. And that's uh perioperative and fortumavidotin plus pembolismap, so EVP. And uh when I say perioperative, I mean you give it in the neoadjuvant setting and you also give it in the adjuvant setting. So neoadjuvant, then you have the surgery, and then you have the the adjuvant treatment. And we saw data presented, the EV303 data was presented at ESMO in 2025, just uh this fall, and that was super positive. And that was in patients that could not receive cyst platinum-based therapy, and it was comparing it just to surgery alone. So the patients got the EV, Pembroke, neoadjuvant, and adjuvant plus the surgery versus just the surgery. Now it doesn't seem like it's a total fair comparison because you have this group that's getting really no systemic treatment, but that is what we did with patients that couldn't get cisplatinum-based chemotherapy. We took them directly to surgery. Now, with adjuvant uh checkpoint inhibitors uh now uh showing promise in terms of disease-free survival and trending toward overall survival, that had become the standard of care with adjuvant nebulamav and adjuvant pembrolyzomab. Um, but that was not included in the EB303 uh study or in the EB304 study. So the control arms really had no adjuvant therapy. So that was a 303 data. There was an improvement in event-free survival, an improvement in pathologic complete response rate, and an improvement in overall survival. So in this meeting at GUASCO, we saw the 304 data, which was a similar study, but the control arm was actually patients that got cis platinum-based chemotherapy in the neoadjuvant setting. So they got four cycles of that, and then four cycle versus four cycles of EV. They both groups had surgery, and the difference was that uh the treatment arm had an adjuvant component of additional EV plus pembro. Now, this is very criticized as to like how much treatment do you need. In both studies, they gave nine cycles of EV plus Pembroke. So in this one it was four and five, and in the other one it was three and six, but still nine cycles of treatment. And it showed an improvement in event-free survival, an improvement in pathologic complete response rate, and an improvement in overall survival. This was in 800 patients. So no longer will we be using cis platinum-based combination therapy if EVP is available in the perioperative setting, because we see here that it improves overall survival. So that's a huge change.

SPEAKER_00 4:00

For sure. Um quick question before you move on to the next one. Did they look at the subset that had a pathologic response? Do you think down the road we can commit for these patients receiving additional adjuvant therapy if they receive pathologic response?

SPEAKER_01 4:15

Yeah, um, they they didn't specifically look at how those patients uh did for this study per se. Um but it's it, you know, it's it's it would be hard to kind of dissect that out. But I think that is a big question is if you have a pathologic complete response to neoadjuvant therapy with EDP, and another thing is you clear the CT DNA because that's that's very important. If if you can check the plasma DNA and then it's it's being cleared, and those patients are probably at really low risk of recurrence. And those patients perhaps don't need to get the adjuvant component, or do they need to get the ADC? Do they need to get the EV? Can they just get the IO, the the embryzimap? So that those are questions that are unanswered right now with the data that we have, but they're important questions, and I think trials should be designed to answer these questions.

SPEAKER_00 5:12

I have no doubt you will. Next, what do you have next for us?

SPEAKER_01 5:15

Um so just staying in muscle invasive bladder cancer, there was a great abstract presented on urinary uh tumor DNA. And I think this is important because we had seen some data on circulating tumor DNA, so CT DNA versus UT DNA. Um, and uh this was based on the Niagara study, the Niagara study. Um we had talked about it before. It's uh it's uh neoadjuvant um uh durvaliumap plus gemcytomesis platinum and then adjuvant dervaliumap, and that showed an improvement compared to GemSys. Well, they took the urinary uh tumor DNA from these patients, so they only had they only had um uh uh biomarker uh urinary uh DNA in in 25% of the patients, so it was like 250 because it was like a thousand patients, so it was like 250 patients where they had urinary tumor DNA, and then they looked at it at two different time points. They looked at it before neoanjuvin therapy and after adjuvant therapy, so one less time point than circulating tumor DNA because there was no bladder after um the radical surgery, so they couldn't check for urinary uh DNA. But so they they checked it at two different time points and they looked at they saw that it was very prognostic. They saw that patients that had uh lower urinary DNA at baselines actually had a better outcome. Um they also saw that um the dervalimav uh increased the rate of uh of uh eliminating the urinary uh DNA. And they also saw that it actually correlated more with pathologic response. So patients that were urinary, urinary DNA negative had a higher incidence of pathologic complete response compared to those that was like 70 or 72 percent, versus um if you were urinary DNA positive, only 18% of those patients had a pathologic complete response. So it really showed uh the the presence of tumor in the bladder as opposed to CT DNA, which correlated a little bit more with muscle invasive disease, lymph node positive disease, and even more, like systemic spread, like metastatic disease.

SPEAKER_00 7:29

Who's doing urinary uh uh uh DNA right now?

SPEAKER_01 7:32

Like who's we're not we're not doing it. This was done through Cignetera, but we're not yet commercially doing it, but it's something that has been incorporated in a lot of perioperative trials, and I think that um it's not ready yet for prime time, but but I think more and more data on this is going to be important, especially as we start looking into bladder preservation studies. I think this will be an important biomarker to follow if we want to treat the bladder, especially locally.

SPEAKER_00 8:00

Okay, that's that's really, really exciting. Next.

SPEAKER_01 8:04

So um the other one I wanted to mention um is a uh study uh in non-muscle invasive bladder cancer. This is the SWOG 1602 study. This is a phase three randomized trial um where they looked at um different strains of BCG. So the TICE uh versus the Tokyo BCG, which um it was this was a non-inferiority study. And this study is is uh very important because it's a cooperative group trial, so it's a huge effort. It was like a thousand patients that were randomized to this study, really um trying to uh look at the problem of BCG shortage and can we use different strains of BCG in order to treat our patients with non-muscle invasive bladder cancer? That was one question. And the second question was really kind of cool. It was like, well, what if we give intradermal BCG? Can that augment the effect of intravesical BCG? We've always kind of thought that it would, and retrospective data had shown that possibly it would, and there's been some preclinical data that showed that perhaps there was like a priming effect. Um so that's what this study tried to answer, and it had three arms. It had um the Tokyo BCG, the TICE BCG, um, and then it also had the the Tokyo BCG with that was primed with uh intradermal BCG. So it it the study showed that um this and the the primary endpoint was high grade recurrence-free survival. Um and uh what the study showed was that there was that that the Tokyo strain was non-inferior to the TICE BCG. So that's great, and that's really important for BCG shortage uh issues. And then um disappointingly though, it showed that the priming didn't make a difference. I was thinking it didn't really improve. I know that was really that was I was really curious about that too. It didn't make a difference. Um there was actually a low rate of PPD conversion, um, but it was it was very interesting how it didn't make a difference.

SPEAKER_00 10:00

All right. Your last one.

SPEAKER_01 10:03

All right, so the last one I'm gonna go to metastatic disease, and uh I wanted to talk about the the phase two study of Decitin Mat Vidotin, and this is an antibody drug conjugate similar to EV, but not exactly. The the vidotin portion is similar, and that's the payload with the MMAE and the linker, but the target is HER2 as opposed to Nectin 4. But we had seen a lot of data out of China that should that was really, really promising and looked very, very similar to what we had seen with EV in terms of uh response rates, about 40 to 50 percent as monotherapy and in the second line setting. Um, we had seen that when it was combined with an IO, we had seen responses of like 70 percent. We saw this, this was this was presented last year at ESMO as a as a um plenary uh discussion, um plenary uh abstract when um they uh they did a phase one trial um combining it with I.O. And it looked very similar to to EV in terms of the response rate, 70% response rate, um again, doubling of the uh of the disease-free survival and and and the overall survival. So it's very, very promising. One of the things that that I think was limiting about this ADC is that you had to be HER2 positive in in order to get this treatment. So this study was very interesting because um what they did is they took patients that were HER2 high. So this is three plus or two plus with fish positivity, or uh, or that were HER2 low. So this is two plus, but fish negative or one plus, and they divided it into the high cohort and the low cohort, and they looked at the overall response rate, the disease pre-survival, and the overall survival with uh with DV, and they found that it was very similar. So that was a little shocking. It was like 55 versus 53 percent in terms of the overall response rate, and the CR rates were very similar, like 17 and 18 percent. So that that was enlightening to us because it it tells us that you only need a a little bit of HER2 positivity in order for the drug to get into the tumor and and have its efficacy in urethyliocarcinoma. So I think the study was really important and um I think the the the data uh was very promising. Now, where where does this treatment fit after you've already gotten EV?

SPEAKER_00 12:38

Tough one. That's a tough one.

SPEAKER_01 12:41

I think I think it's tough, right? Because you're using the same chemo, the same MMAE. So we don't know the answer to that, and there may not be a lot of efficacy if you've already gotten the MMAE. So um I think that that that's a tough one, yeah.

SPEAKER_00 12:56

I suspect that's probably one question that I suspect the field is not gonna spend resources addressing because you started. I mean, you there's only limited number of trials that you could do and limited number of patients you can enroll to. So you have to pick your battles, which are the most trials that you need to address. Andrew, thank you so much. This was so helpful just to get a quick recap of what we need to pay attention to from ASCO GU 2026.

SPEAKER_01 13:22

Oh, my pleasure, my pleasure. It was a great bladder session. Um, and uh, you know, I was uh really lucky to be uh part of it.

SPEAKER_00 13:32

Oh, I mean, as the co chair, you did amazing, amazing work. Congratulations.

SPEAKER_01 13:36

Thank you.

SPEAKER_00 13:38

Thank you for listening to this edition of Healthcare Uncle Express. Until next time, take care.