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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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 drugs.
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.
Yeah, this is this to me, it's like a dream come true. So we've always given patients platinum based chemotherapy for bladder cancer with really not that impressive results. But, you know, we've done a lot of trials and we really struggle to do better than platinum based chemotherapy. And now we're doing this in the metastatic setting and we're bringing it to the perioperative setting.
So I think it's a really exciting time where we can actually play around with the therapies that we have in terms of designing clinical trials and find the best treatment options for patients and hopefully in the future, spare their bladder and improve their overall survival, which is really the goal.
Yeah, so I was so excited to see the results of this study, especially after last year, we saw the really exciting results of EV plus PEMBRO in the metastatic setting. And then we saw the Checkmate 901 data, where when nivolumab was added to GEMSYS, it did better than just GEMSYS alone. And that just kind of set the stage for the perioperative trials that are
ongoing right now, and Niagara was the first one to report its outcome. And, you know, once I saw that the Checkmate 901 study was positive, that adding nivolumab actually did improve outcomes to platinum-based chemotherapy, but to cisplatinum-based chemotherapy, it didn't have as strong effect with carboplatinum. So that was...
important because we give cis-platinum-based chemotherapy for patients with muscle-invasive disease in the perioperative setting, neoadjuvant and adjuvant. So that's why I was really excited to hear the results of the Niagara. And of course, we had the press release that it was positive. So really excited to see the results of that trial.
So great question. And that was one of the things that I really liked about this trial was that it was very practical and real world. And that's what I do in the real world is I go down to 40 and I split the dose. If I can make a patient cis-platinum eligible, I do. And whatever I can do to help the patient become platinum eligible is very important to me, cis-platinum eligible specifically.
So I will split the dose of cis-platinum and it's more tolerable. And that's what they did in this trial. And I really like that.
So great question. I think the standard of care has been the standard of care for a while until we had the approval of nivolumab in the adjuvant setting. And that just happened. It wasn't that long ago. 2021 was when that occurred. And I think that what I would have done differently had I known the activity of nivolumab and the activity of pembrolizumab.
The ambassador study that I presented at ESMO and I presented the updated 45-month follow-up data. I would have done an adaptive design where if the patients had a pathologic complete response, then maybe we don't need the adjuvant approach. But the truth is we don't really know that, right? Because if we think about this as systemic disease, then maybe they do actually have
need a little bit more therapy in the adjuvant setting, even if they achieved a pathologic complete response. But I would have designed it more adaptively. And if the patients didn't respond, I don't think I would have continued adjuvant dervalumab because would there be I don't think there would be a good rationale to continue a therapy that didn't work in the neoadjuvant setting.
Now, that's not the way it was designed. Everybody got neoadjuvant in the treatment arm and everybody got adjuvant in the treatment arm. And in the control arm, nobody got adjuvant. But I think that it was a fair design without making it multi-arms. That would have been another way of doing it, but it's already a thousand patients.
So this would have made it a lot larger where we don't give adjuvant in a different arm. And it's not an adaptive design. It's just a different arm where patients do get adjuvant and then another arm where patients don't get adjuvant. So I think a lot to learn from this trial and we yet don't have
The granularity of the data is if they did response, let's say they had a pathologic complete response, how did those patients do with adjuvant therapy versus if they didn't? How did they do with adjuvant therapy? How did they do in terms of event-free survival, which was the primary endpoint? So I think all these questions will be answered as the data is reported a little bit more and it matures.
We've been using it as a surrogate for what's going on in the rest of the body. If you're downstaging, if you're responding in the bladder, which is something that we can observe and stage, although you can argue not as well as we think we can, at least that kind of gives us an idea of what's going on. And
And that's I think this study will actually help us to understand the role of pathologic complete response. And there's so many definitions of what actually is a complete response, a complete pathologic response. Do you count the carcinoma in situ? Do you count the low grade TAs? How rigid are you? Or is it just any non-muscle invasive diseases counted as a pathologic response?
I think that there's the definitions have been really variable. So it's been a hard endpoint to use. But I think we'll learn a lot from this trial.
I think that'll be really important because that will be our ultimate goal. So those patients that failed because they didn't get a cystectomy, if it was by choice, then it's not really a failure. I think those patients should be followed. And I don't know if they got adjuvant therapy. I think it was mixed. Some of them did get adjuvant therapy, even though they did not undergo a cystectomy.
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