Siamak Daneshmand, MD, discusses TAR-200 and what led investigators to evaluate the agent in the phase 2b SunRISE-1 study.
Siamak Daneshmand, MD, professor of urology at the Keck School of Medicine of USC, discusses TAR-200 and what led investigators to evaluate the agent in the phase 2b SunRISE-1 study (NCT04640623).
TAR-200 is a novel, intravesical drug delivery system which provides sustained, local release of gemcitabine into the bladder. This action occurs over a 21-day dosing cycle. In the SunRISE-1 study, TAR-200 was given with cetrelimab (JNJ-63723283), a PD-1 inhibitor. These agents given in combination may display synergistic activity and lead to improved outcomes in patients with non–muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG).
In the open-label, parallel-group, multicenter, phase 2 trial, TAR-200 was given to patients every 3 weeks for 24 weeks, followed by every 12 weeks until week 96, along with cetrelimab given through week 78. The primary end point is complete response rate at any time point, with secondary end points of duration of response, overall survival, pharmacokinetics, quality of life, safety, and tolerability.
0:10 | TAR-200 is a sort of a pretzel device. It's a novel drug delivery mechanism that's placed inside the bladder, for sustained release of gemcitabine. These are tablets within the little pretzel device that are placed in the bladder through a special catheter and stylet. They are very easily placed in the office setting. The urine creates an automatic pump, and the little tablets will then elude the chemotherapy through a sort of central pour over a sustained period, in this case, 3 weeks. The idea is that if you get the drug in the bladder for a prolonged period, it will be more efficacious. And that's been our experience.
1:00 | We did have a phase 1 trial in this setting in 2016 and 2017 and saw some complete responses in the pre-cystectomy timeframe. Patients who were not eligible for neoadjuvant chemotherapy underwent this principal device placement 1 month prior to cystectomy. We saw an early signal that this is having a response in the tumor. That is what led to this trial.