An investigational new treatment called TAR-200 is offering hope to patients with high-risk non–muscle-invasive bladder cancer (NMIBC) whose cancer has not responded to standard BCG therapy. Recent results from the phase 2 SunRISe-1 trial, presented at the 2025 American Urological Association Annual Meeting, highlight TAR-200’s ability to keep patients cancer-free for a longer period and help many avoid bladder removal surgery.
Key Highlights for Patients:
- High Rate of Staying Cancer-Free: More than 82% of patients achieved a complete response, meaning their cancer was undetectable after treatment, and over half of these patients remained cancer-free for at least one year.
- Bladder Preservation: At 12 months, nearly 87% of patients had not needed to undergo bladder removal (cystectomy).
- Durable Results: Many patients continued to benefit from the treatment for over two years, with the average duration of response still being measured.
- Mild Side Effects: Most side effects were mild urinary symptoms, such as frequent urination or discomfort. Serious treatment-related side effects occurred in about 6% of patients, and no treatment-related deaths were reported.
About TAR-200:
TAR-200 is a small device placed inside the bladder that slowly releases the chemotherapy drug gemcitabine directly where it’s needed. This approach allows for continuous treatment of the bladder lining with minimal inconvenience to the patient.
What This Means for Patients:
The ongoing phase 3 SunRISe-5 trial will provide more information on its benefits compared to other therapies. In early 2025, a new drug application seeking approval of TAR-200 was submitted to the FDA for review.
More Reading
Bladder Cancer Overview
FDA Grants Fast Track Designation to GemRIS™ in Muscle Invasive Bladder Cancer
Join the conversation on CancerConnect!
Reference
Guerrero-Ramos F, Jacob JM, Van der Heijden MS, et al. TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: first results from Cohort 4 of SunRISe-1. Presented at: 2025 AUA Annual Meeting; April 26-29, 2025; Las Vegas, NV.
