J&J's TAR-200 Shows Promise in Non-Muscle-Invasive Bladder Cancer Treatment

Johnson & Johnson's investigational drug-device combination, TAR-200, has demonstrated encouraging results in treating high-risk non-muscle-invasive bladder cancer (NMIBC), according to data presented at the 2025 Annual Meeting of the American Urological Association. The targeted drug release device, which delivers gemcitabine directly to the bladder, has shown durable response rates and sustained disease control in specific patient populations.

SunRISe-1 Trial Results

The Phase IIb SunRISe-1 trial focused on two key patient cohorts. In the carcinoma in situ cohort, which included 85 patients ineligible for or declining radical cystectomy and unresponsive to Bacillus Calmette-Guérin treatment, TAR-200 elicited a complete response rate of 82.4%. Notably, 52.9% of these responders maintained undetectable cancer levels at one year, with a median duration of response of 25.8 months.

In cohort 4, which evaluated TAR-200 as an alternative to surgery in 52 patients with papillary-only disease, the drug-device combo achieved a disease-free survival rate exceeding 80%. Importantly, 94% of treated patients were able to preserve their bladders.

Safety Profile and Regulatory Status

TAR-200 demonstrated an acceptable safety profile across both studies, with most side effects being mild and quickly resolved or manageable. Serious events were rare, with seven patients discontinuing treatment due to toxicities. No treatment-related deaths were reported.

The promising results have bolstered expectations for TAR-200's regulatory prospects. In January, Johnson & Johnson initiated a rolling application for TAR-200 with the FDA. The product received Breakthrough Therapy Designation from the FDA in December 2023, and analysts at Guggenheim Partners anticipate accelerated approval later this year.