TAR-200 Shows Durable Response in BCG-Unresponsive NMIBC: SunRISe-1 Cohort 2

Joseph Jacob, MD, associate professor of urology at Upstate Medical University, discusses data from the phase 2b SunRISe-1 study, cohort 2, evaluating TAR-200, an investigational intravesical gemcitabine-releasing system, in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who are ineligible for or refuse radical cystectomy.

Data from this study were presented at the 2025 American Urological Association (AUA) Annual Meeting. As of March 2025, 82.4% (95% CI, 72.6-89.8) of the 85 enrolled patients achieved a complete response (CR), defined as undetectable cancer following treatment. Notably, this high response rate translated into durable disease control, with 52.9% of responders maintaining CR at 1 year without the need for reinduction therapy. The median duration of response was 25.8 months (95% CI, 8.3-not estimable), suggesting prolonged cancer-free survival. Furthermore, at 12 months, 86.6% of responders remained cystectomy-free.

TAR-200 also demonstrated a favorable safety profile. The majority of treatment-related adverse events (TRAEs) were low-grade urinary symptoms. Only 12.9% experienced Grade 3 or higher TRAEs, and treatment discontinuation due to TRAEs occurred in a low 3.5% of patients, with no treatment-related deaths reported.

These findings highlight TAR-200 as a potentially practice-changing, highly effective, and well-tolerated treatment option for this challenging patient population. The high CR rate and sustained responses without reinduction offer a significant advancement for patients with BCG-unresponsive HR-NMIBC with CIS who are not candidates for or decline radical cystectomy.

In addition, the FDA has already granted breakthrough therapy designation to TAR-200 for this indication, and a new drug application is under review. Further investigation in ongoing phase 3 trials will solidify its role in the treatment landscape.

REFERENCE:

Necchi A, Daneshmand S, Simone G, et al. Practice-changing, Paradigm-shifting Clinical Trials in Urology: TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcome. Presented at: 2025 American Urological Association Annual Meeting. April 26-29, 2025. Las Vegas, NV.