Johnson & Johnson Says First Results From Cohort 4 Of Phase 2B Sunrise-1 Study Show Potential Of TAR-200 Monotherapy In Patients With Papillary-only, High-risk Non-muscle Invasive Bladder Cancer

TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2)

Compelling first results from Cohort 4 of Phase 2b SunRISe-1 study show potential of TAR-200 monotherapy in patients with papillary-only, high-risk non-muscle invasive bladder cancer

RARITAN, N.J., April 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today that new data from its leading oncology pipeline will be presented at the American Urological Association (AUA) 2025 Annual Meeting, taking place April 26-29 in Las Vegas. Among the highlights are the 12-month duration of response (DOR) data from the Phase 2b Cohort 2 SunRISe-1 study, evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with Bacillus Calmette-Guérin (BCG)—unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) with or without papillary disease. These findings will be featured in the Practice-changing, Paradigm-shifting Clinical Trials in Urology plenary session on Saturday, April 26.

A second plenary presentation will feature first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive, papillary-only HR-NMIBC. In this patient population, bladder removal remains a standard treatment, but many patients are elderly, have significant comorbidities, or are unwilling to undergo radical surgery, making treatment challenging.