Siamak Daneshmand, MD, on safety/tolerability data from SunRISe-1

In this video, Siamak Daneshmand, MD, highlights data on the safety and tolerability of TAR-200 monotherapy in patients with non–muscle-invasive bladder cancer (NMIBC), which were shared at the Society of Urologic Oncology 25th Annual Meeting in Dallas, Texas. Daneshmand is a professor of urology and director of clinical research at the Keck School of Medicine of the University of Southern California, Los Angeles.

Video Transcript:

Could you describe the background/design of the SunRISe-1 trial?

TAR-200 is an intravesical gemcitabine releasing system. This has been a very exciting trial. This is for non–muscle invasive-bladder cancer that's unresponsive to BCG. Initially, there were 3 cohorts. One was cetrelimab, which is a PD-1 inhibitor, alone. Cohort 2 [was] TAR-200 alone, and cohort 3 [was] TAR-200 plus cetrelimab. Later, there was a cohort 4 that was added for papillary disease only. But these are basically patients [with] BCG-unresponsive CIS with or without papillary disease. The idea was to see what the efficacy of this gemcitabine releasing system was for these patients. We concentrated mostly on the TAR-200 alone arm. There was data released from the cetrelimab alone arm, which had about a 37% complete response rates, which are in line with what we've seen with other PD-1 inhibitors in the past. So, one of the objectives was, of course, to see the efficacy—that was the main objective—but at the same time to see safety and tolerability of this device. We'd seen the safety in the previous phase 1 studies, and it seemed to be very tolerable. But this was obviously a much larger global scale clinical trial.

What were the key findings on safety and tolerability?

As we get mature data, everyone's interested in how well these devices are tolerated. At the end of the day, this is a device that's in the bladder that's floating in there for 3 weeks at a time, so it's of great interest to know how patients are tolerating it. These side effects and AEs and profiles were very meticulously annotated throughout the trial. It turns out, it is actually very well tolerated. Most of the AEs are grade 1 and 2 [and were] things that we're completely used to as urologists with intravesical therapies of all kinds for treatment of non–muscle-invasive bladder cancer.

We wanted to know how many patients discontinued therapy. There were 85 patients, and 5 patients discontinued therapy because of side effects. So, very low number that had the device removed for side effects. I mentioned that most of the AEs were grade 1 and 2. These consisted of frequency, urgency, UTIs—again, things we're very used to with intravesical therapies. These are the risks of all intravesical therapies. There were very few grade 3 AEs, or 9% of the patients had grade 3 AEs, consisting of infections, UTI, urinary retention, and things like that. Again, hematuria is another one that we see often with any kind of intravesical therapy. Most of it is related to probably catheter insertion. But overall, again, very well tolerated. The vast majority of patients were able to maintain the device in for 3 weeks and went on to continue therapy. This is a therapy that's being given every 3 weeks for the first 6 months, and then after that, it's quarterly. So, we're very happy to see both its continued efficacy results as well as the low AEs.

This transcript was AI generated and edited by human editors for clarity.