Johnson & Johnson Reports Positive Results for Gemcitabine Intravesical System in High-Risk NMIBC Trial
Reuters
Dec 06
Johnson & Johnson Reports Positive Results for Gemcitabine Intravesical System in High-Risk NMIBC Trial
Johnson & Johnson has announced new data from Cohort 4 of the Phase 2b SunRISe-1 study evaluating the investigational gemcitabine intravesical system (INLEXZO™) in patients with Bacillus Calmette-Guérin $(BCG)$-unresponsive, high-risk, papillary-only non-muscle invasive bladder cancer (NMIBC). The results, presented as a late-breaking oral presentation at the Society of Urologic Oncology (SUO) 2025 Annual Meeting and previously at the 2025 American Urological Association (AUA) Annual Meeting, showed that treatment with the gemcitabine intravesical system achieved a 74 percent disease-free survival rate at one year. More than 95 percent of patients remained progression-free, and over 92 percent did not undergo bladder removal at one year. These findings support continued evaluation of the therapy in the ongoing Phase 3 SunRISe-5 study.
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