(UroToday.com) The American Urologic Association (AUA) 2025 Annual Meeting held in Las Vegas, NV between April 26th and 29th, 2025 was host to a bladder cancer clinical trials in progress session. Dr. Sima Porten presented SunRISe-5, a phase III, randomized, open-label study comparing TAR-200 to intravesical chemotherapy after bacillus Calmette-Guérin (BCG) in recurrent, high-risk (HR), non–muscle-invasive bladder cancer (NMIBC).
Standard of care for papillary disease–only HR NMIBC remains TURBT, followed by intravesical BCG treatment. However, 12–78% of patients with HR NMIBC experience disease recurrence following BCG treatment. Additional BCG has limited efficacy in HR NMIBC with early recurrences (within 1 year) and is not currently recommended by guidelines.
Radical cystectomy is the current standard of care for early BCG-unresponsive recurrence (within 1 year) of papillary disease–only HR NMIBC. Dr. Porten emphasized that radical cystectomy is a life-changing operation associated with considerable morbidity, mortality, and impact on quality of life. Many patients either refuse or are ineligible for radical cystectomy. Approved treatment options for HR NMIBC are limited and are restricted to patients with CIS. As such, there is a high unmet need to develop bladder-sparing, localized treatments for patients with recurrent papillary disease-only HR NMIBC.
TAR-200 is an intravesical drug releasing system designed for the sustained delivery of gemcitabine in the bladder. Results from SunRISe-1 (NCT04640623) support further investigation of TAR-200 monotherapy in patients with BCG-unresponsive HR NMIBC.
SunRISe-5 is an open-label, multicenter phase III trial that is enrolling patients with histologically confirmed, papillary-only HR NMIBC with disease recurrence within the 1st year of the last dose of BCG and who are ineligible for/refusing radical cystectomy to:
- TAR-200 monotherapy
- Every 3 weeks through Week 24
- Every 12 weeks through Week 96
- Intravesical gemcitabine or mitomycin
The primary endpoint is disease-free survival, defined as the time from randomization to first recurrence of HR NMIBC (high-grade Ta, any T1 or CIS), progression, or any-cause death, whichever occurs first.
The definitions for minimum prior BCG therapy in the SunRISe-5 target population are as follows:
The first global site opened March 29, 2024. SunRISe-5 is completing recruitment at 122 sites across Argentina, Belgium, Brazil, China, France, Germany, Italy, Japan, Poland, Romania, South Korea, Spain, the United Kingdom, and the United States.
Presented by: Sima Porten, MD, MPH, Associate Professor, Urologic Oncologist, Department of Urology, UCSF, San Francisco, CA
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the 2025 American Urological Association (AUA) annual meeting held in Las Vegas, NV, Saturday, April 26 - Tuesday, April 29, 2025