Dr. Andrea Apolo
speaker
97 appearances
1 recordings
1 series
first heard Oct 2024
last heard Oct 2024
Dr. Andrea Apolo’s voice in public audio — every appearance, attributed to the second.
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is trying to answer that question, treating with atezolizumab, using ctDNA to treat those patients. The modern study here in the US is also asking that question, using ctDNA to decide whether you intensify the treatment or whether you do you really need the treatment, and really only treating the patients that are ctDNA positive or that convert to ctDNA positive in a randomized fashion.
So I love that. And the Tembola trial did that in a non-randomized fashion using ctDNA and seeing if they can treat the patients that are ctDNA positive or convert to positive with adjuvant atezolizumab and seeing if those patients did better. And the nice thing is that they showed that One of the things that was really interesting, I thought that they showed was that high risk.
So so we categorize patients into high risk and low risk patients. Right. And yes, the high risk patients had CT DNA, but not all of them did. And then there were some patients that were not high risk, you know, by our criteria. And they about half of them still had positive CT DNA. So, you know, we think we're good using clinical baseline characteristics in terms of how to make patient how to.
how to stratify patients into the highest risk. But we may not be capturing all the patients that are actually high risk and do need treatment in the adjuvant setting. So I really like that part of the Tembola trial and then following them and seeing they convert you know, how many of them converted with treatment, and then how did they do with the tezolizumab treatment.
So I think that this is a really important study, and more studies are going to be done that are actually randomized. So this kind of set the stage, and we have retrospective data also. So I think this kind of sets the stage for the importance of ctDNA within this perioperative study, and then what to do if you do have a positive ctDNA response. how to follow the patients, kind of what to expect.
I mean, this is all evolving right now as we speak. So I think it's really exciting to have a biomarker to work with.
That's a little much. We decreased that. And I liked how sensitive it was, really, of the ctDNA negative patients. Only two of the patients developed metastases. Now, of course, my hope would be that it would be zero and that it would be super sensitive and it would pick that up. And we saw that also.
In the early data presented from the InVigor 011, where they followed patients that were ctDNA negative, and they did see that some patients, although a really small percentage of patients that were ctDNA negative, did have progressive disease that was metastatic, that was not picked up.
They were, and I think that we're only getting better. So we're only getting better. The assays are getting more sensitive. They're including methylation. They're even doing whole genome sequencing instead of whole exome sequencing now. So I think the biomarker is evolving, and we're only going to get more sensitive.
And sometimes I struggle when I don't see anything and the patient has already undergone all the treatments. So they've already undergone neoadjuvant chemotherapy, undergone radical surgery, undergone adjuvant checkpoint, and their NAD, and then they have this positive ctDNA. I don't know what to do at that point. Do I start more systemic therapy? How do I intensify the treatment?
Do I restart checkpoint inhibitor? I mean, I think there's a lot of unanswered questions. The marker is available for us here in the US. And I think we need to learn how to use that tool a little bit better than what we know now. But I think it'll come.
And that would be the right thing to do, but it's hard for me not to check because I know that it's an available tool. And of course I want as much data as possible to make an informed decision for patients. But in some scenarios, we don't have the right answers to what to do with that result.
I don't know the answer to that, but I do tell you that initially I was, when a patient got checkpoint and they develop metastatic disease, I was moving on to EV alone, but The more I thought about it and the more I discussed it with patients, I think that there's a synergy with EV plus Pembro and I think that it's reasonable to try to intensify the treatment that they're receiving.
So even if they progressed on checkpoint, continuing checkpoint and giving the infortimavidotin with pembrolizumab in the metastatic setting. So I am doing that. I don't think it's wrong just to give EV by itself, but I don't know what the right
And whether we continue the checkpoint inhibitor or not, there is data in kidney cancer where there is no benefit to continuing a checkpoint inhibitor once a patient has progressed on it. But most of it has been done in the metastatic setting, although the most recent data with Tivolumab was done a little bit earlier.
It did have some patients that had received adjuvant therapy, but a small number. And they did not see a benefit to continuing checkpoints. So I think this is an unanswered question. All cancers behave differently, have a different biology. We know that bladder cancer is not kidney cancer. So I think we need to answer this question prospectively.
And for now, if the patient can tolerate it, I do continue the checkpoint if they develop metastatic disease with and for Tamavidotin.
Yeah, I'm actually excited about the TAR system. The TAR 200 is with gemcitabine. But I'm excited about the whole device and the way that you can deliver it into the bladder so easily. And it delivers a slow amount of drug into the bladder. I love that. And the possibility that you can put other active therapies in there. So I'm really excited about it. And I think we do need...
something that kind of manages the bladder, right? So we have these great systemic therapies, but although most patients when they're responding to systemic therapies also respond within the bladder, it'd be nice to have an additional intensification of treatment in the bladder potentially in the future to have bladder sparing approaches.
And this may be a way of doing it, intensifying treatment with these tar systems and then leaving the bladder intact potentially.
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