SunRISe-1: TAR-200 and Cetrelimab in Patients With High-Risk NMIBC


Following a review of the limitations of current treatment options, Neal Shore, MD, MFACS, discusses the SunRISe-1 trial investigating TAR-200 plus cetrelimab in patients with high-risk NMIBC.

This is a video synopsis/summary of an Investigator Perspectives featuring Neal Shore, MD, FACS.

Dr Shore discusses limitations of current treatments for high-risk non–muscle-invasive bladder cancer (NMIBC). Bacillus Calmette-Guérin (BCG) shortages occur, and manufacturing complexity contributes. Intravesical chemotherapy has more success in intermediate-risk patients. With high-risk disease, bladder removal (cystectomy) is often recommended, which has risks including mortality.

The SunRISe-1 trial is evaluating an investigational drug delivery device called TAR-200, which provides sustained-release gemcitabine directly into the bladder vs standard intravesical chemotherapy. Early results presented at the American Urological Association 2023 Annual Meeting showed approximately 90% complete response at 3 months and approximately 80% at 6 months when TAR-200 is used as monotherapy in BCG-unresponsive, high-risk NMIBC patients who refused or were ineligible for cystectomy. TAR-200 is also being studied with cetrelimab, a PD-1 checkpoint inhibitor.

The patients enrolled have received at least 5 of 6 BCG induction courses plus 2 of 3 maintenance courses, meeting criteria for BCG-unresponsive disease. They refused or were ineligible for cystectomy, often due to comorbidities. The TAR-200 device is easily placed and removed in the clinic setting without need for systemic anesthesia.

Video synopsis is AI-generated and reviewed by Urology Times® editorial staff.

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