Pharmaceutical company Johnson & Johnson (J&J) (NYSE:JNJ) on Saturday announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200 -- an intravesical gemcitabine releasing system -- for patients with certain types of bladder cancer.
The company said that the findings demonstrate the highest complete response rate without reinduction, with more than half of responders remaining cancer-free for at least 12 months.
These results highlight the potential of TAR-200 as a breakthrough for people with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumours, who are ineligible or refuse radical cystectomy (RC). These results were featured at the 2025 American Urological Association (AUA) Annual Meeting.
"Treatment with TAR-200 has long-lasting effectiveness. More than 82% of patients achieved a complete response, and of those that initially responded to treatment, more than half showed no signs of cancer at one year," said Joseph Jacob, M.D., MCR, associate professor of Urology at Upstate Medical University and presenting author. "These findings represent the highest complete response rate observed for patients with HR-NMIBC and underscore the potential of TAR-200 to provide long-lasting cancer control for patients."
TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient procedure, without the need for anaesthesia. Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of treatment throughout the day, J&J said. To date, TAR-200 has been placed more than 10,000 times as part of the SunRISe clinical programme.
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