Johnson & Johnson announced promising early results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200 for patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary-only disease. TAR-200 achieved a disease-free survival rate of over 80 percent without the need for reinduction and enabled 94 percent of patients to avoid bladder removal surgery. Progression-free survival at nine months was 95 percent, and overall survival was 98 percent.

TAR-200, an intravesical gemcitabine-releasing system, showed a strong safety profile, with most treatment-related adverse events being low grade and resolving quickly. These results were presented at the 2025 American Urological Association Annual Meeting. The findings support the potential of TAR-200 as a less invasive, effective alternative to radical cystectomy and are being further evaluated in the ongoing Phase 3 SunRISe-5 study.