Dr. Bogdana Schmidt
speaker
69 appearances
1 recordings
1 series
first heard Oct 2024
last heard Oct 2024
Dr. Bogdana Schmidt’s voice in public audio — every appearance, attributed to the second.
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Quite a few patients that are cured by surgery alone maybe don't need adjuvant or including that neoadjuvant space. So we're all talking about other markers. Is it imaging? Is it blood? Is it urine? We had the TOMBL trial presented.
What do you think about that if you want to talk about TOMBL or you want to talk about what you're doing in practice and how you're trying to answer that question for your patients now? Yeah.
Now, absolutely. And just to highlight a couple of details from Tambola. So you're absolutely right. Over 52% of their patients were CT DNA positive after cystectomy, which is a lot higher than you would think, at least certainly higher than I would have guessed.
And the wonderful thing is they were doing very serial kind of monthly measurements and 75% of patients were detected in less than four months. So you're thinking about adjuvant therapy. Generally, we start within three months, right, based on the trial. So
Using ctDNA, we would have that window to pick those patients and still have time to start them on the treatment that we would start, but potentially select out the ones that maybe didn't need it. Now, I'm looking forward to the rest of their manuscript data to see how often do you actually need to be checking.
Correct. And that was 10%. So you said, you're right, for Tombola, it was 15%. Two patients, 3%, but in the Invigor, it was up to 10% of patients. But I kind of wonder if that has to do with the sensitivity of the assays. They were doing different assays in these studies.
So in your perfect scenario of this perfect biomarker that I truly am optimistic it'll come. It may not be perfect right away, but we'll have something where we have nothing right now. Do you use ctDNA in your practice right now to make decisions? I do. I do.
Yeah, I think so too. I think the medical oncologists I work with who are phenomenal and I love them and trust them very much, but they have the same struggles that you're experiencing. They actually don't wanna check because they don't know what to do with that information.
And I think the prospective data at InVigor and Modern, like you mentioned, are going to give us that data and hopefully help us figure out how to interpret this so that we have less hesitation to get the data in the first place so that we sort of know what to do with it.
So this gets me into my next question, which I wanted to ask after Niagara, and then I wanted to ask after Ambassador, and I figure I just have to ask it now. So the earlier and earlier in the system that we're introducing checkpoints, right? We hope, of course, that all of that works and our patients don't progress and don't develop metastatic disease.
And that's why we do all of it, which makes perfect sense. But now that we have really great EV PEMBRO data for metastatic disease, and I know you don't have a crystal ball to tell me for sure how using checkpoint up front will impact that data. But what do you think? Are you worried that it'll make that data look worse? Or do you hope that it'll make it look better because of a priming effect?
Thank you. And like I said, this is something that we're all going to ask more and more as we basically have more of these patients, right? Right now, these are all patients that have just been on trial. And so we'll be following them closely. But as we start to make these decisions, hopefully we'll get some more real world. evidence in this space.
So we've spoken about the more advanced bladder cancer setting, the muscle invasive, kind of how to make these decisions. I do want to talk a little bit, just for the surgeons in the audience, about some of the more surgical trials, the Sunrise trials, starting with Sunrise. four, which was the muscle invasive trial with citralumab and TAR200.
And I think this one points a really great point on what we mentioned earlier with the patients who refuse cisplatin. In this set of patients, there are just 60-something percent of patients that enrolled on this trial We're cisplatinum eligible, but refusing cisplatinum.
I think speaking to investigator excitement potentially and wanting to get patients on trial, but also speaking to the fact that patients don't want cisplatinum. They want something newer, better, hopefully less toxic. And now that we have these newer agents, newer devices, delivery mechanisms, I think this is interesting to figure out how are we going to incorporate that into the paradigm.
Yeah, so just to quickly introduce Sunrise for kind of the concept. So this was the muscle invasive patients who were chemo ineligible or refusing, who got TAR200 plus citrelumab versus citrelumab monotherapy. And this was in that five to three randomization that maybe we can talk about a little bit. Those patients then went on to get radical cystectomy.
And because this was phase two, we were looking at pathologic complete response patients. as the primary endpoint in these patients. And it was really, you know, I think, striking. CR in that combo arm, TAR200 plus citralumab, was 42%, which is sort of what we saw in the neoadjuvant chemo trials. Nothing went above 30%, right? So there's some neoadjuvant immunotherapy trials, but
PathCR 42% with complete response. I think it's promising, very promising.
Absolutely. And then just getting to Sunrise One, which was obviously in the non-muscle invasive space, they also showed incredibly promising results, 83% with just TAR 200 alone, which I think is really great. I'm personally, as a surgeon, a big believer in TAR. intravesical treatments for intravesical-only non-muscle invasive disease.
But looking at, there have been a couple combination trials now, right? So the Sunrise 1, looking initially with a citrelumab plus tar, and then you have data with creatostimogene in combination with PEMBRO. I think that, and then, of course, we had the PEMBRO data alone, which To me, that doesn't seem to be the primary direction that people are going.
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