GU Cancers 2024 | Why do BCG-unresponsive patients with NMIBC refuse radical cystectomy?

So the SunRISe-1 trial is looking at BCG unresponsive patients. So these are heavily pretreated patients. And classically this has been a very difficult population to treat. Not only do they have issues with response rates, we just haven’t had very many options to give these patients and the standard of care, unfortunately, has been radical cystectomy. Most urologists and most patients believe that radical cystectomy may be a little bit too aggressive in this patient population. So as a community, we’ve been looking for salvage therapies. So this is a drug that is trying to salvage patients that have, you know, have become unresponsive to BCG. So the the interesting thing about this trial is it’s a it’s a device trial as well. So it’s a it’s a novel device. It’s a silicone device that is deployed into the bladder by a urologist and it looks like a pretzel. And it floats in the, in the bladder, in the urine. And it is the pretzel device has like sustained release gemcitabine tablets and is able to deliver a durable dose of gemcitabine to, the tumor. So the trial originally was a three arm trial. To make a long story short, they got rid of the immunotherapy combination arms. And so what we’re talking about today is a intravesical therapy alone arm. And so these are patients that only receive the what’s called the Tar 200 device, the intravesical gemcitabine sustained release device. And patients had a so far phenomenal response. So the primary endpoint was complete response rate, and the complete response rate is around 80%, which is you know we haven’t seen numbers like that in the past. So everyone’s excited about the data.