Dr Daneshmand on Findings From the SunRISE-1 Trial of TAR-200 in BCG-Unresponsive NMIBC

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Partner | Cancer Centers | <b>USC Norris Comprehensive Cancer Center</b>

Sia Daneshmand MD, discusses key efficacy findings from the SunRISE-1 trial of TAR-200 in patients with BCG-unresponsive, high-risk NMIBC with CIS.

“These are exciting results. We also have ongoing follow-up of the patients, and ongoing results will be presented and published soon.”

Sia Daneshmand MD, professor, urology, clinical scholar designation; director, Clinical Research, urologic oncology fellowship, Keck School of Medicine, University of Southern California, discusses key efficacy findings from the phase 2b SunRISE-1 trial (NCT04640623) that may support the FDA approval of TAR-200, an intravesical gemcitabine delivery system, for the treatment of patients with Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), regardless of the presence of papillary tumors.

Results from the TAR-200 monotherapy arm of SunRISE-1 (n = 85) show that, at a data cutoff date of May 13, 2024, the complete response (CR) rate among patients with BCG-unresponsive, high-risk NMIBC with CIS with or without papillary disease was 83.5% (95% CI, 73.9%-90.7%). Additionally, the estimated 12-month CR rate was 57.4% (95% CI, 40.6%-71.0%) and the estimated 12-month duration of response (DOR) rate was 65.7% (95% CI, 45.2%-80.1%). Notably, responses were ongoing in 81.6% of responders at a median follow-up of 9.2 months (range, 3.7-36.6).

Daneshmand begins by stating that this CR rate with TAR-200 has been unprecedented among other bladder cancer treatments that have been examined in earlier-phase trials. The ongoing evaluation of additional end points, including DOR, will provide further insights into the efficacy of this therapy, he says.

During the first 6 months of treatment, TAR-200 is placed in the bladder once every 3 weeks, according to Daneshmand. Thereafter, the treatment is placed in the bladder once every 3 months for a maximum of 2 years or for as long as the patient is disease free, he explains. Prespecified disease assessments and ongoing follow-up of patients on the study will be shared in the future, he concludes.