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Johnson & Johnson Announces New Data From Investigational Cohort 4 Of Phase 2b SunRISe-1 Study Show Treatment With Gemcitabine Intravesical System Resulted In High One-Year DFS, PFS, And OS Rates In Patients With BCG-Unresponsive, High-Risk, Papillary-Only NMIBC

BenzingaDecember 05, 2025 at 9:23 PMFull Content
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Gist

Johnson & Johnson reports promising Phase 2b trial results for its gemcitabine intravesical system, showing high survival rates in patients with high-risk bladder cancer unresponsive to BCG therapy.

LLM Summary

New data from Cohort 4 of the SunRISe-1 study show that the investigational gemcitabine intravesical system achieved over 95% progression-free survival and over 92% disease-free survival at one year in patients with BCG-unresponsive, high-risk papillary-only NMIBC. The results were presented at the SUO 2025 Annual Meeting and highlight a potential new therapy for bladder preservation.

Full Article Content

New data from Cohort 4 of the SunRISe-1 study show more than 95 percent of patients remained progression free at one year, with more than 92 percent not undergoing bladder removal

Patients with this type of bladder cancer have limited choices beyond radical cystectomy, highlighting the need for newer therapies for bladder preservation

RARITAN, N.J., Dec. 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that new data from the investigational Cohort 4 of the Phase 2b SunRISe-1 study show treatment with gemcitabine intravesical system resulted in high one-year disease-free survival (DFS), progression-free survival (PFS), and overall survival (OS) rates in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, papillary-only non-muscle invasive bladder cancer (NMIBC).1 These data were featured as a late-breaking oral presentation at the Society of Urologic Oncology (SUO) 2025 Annual Meeting and build upon data presented at the 2025 American Urological Association (AUA) Annual Meeting.

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Author:
Benzinga Newsdesk
Tickers:
JNJ
Updated At:
December 05, 2025 at 5:23 PM
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New data from Cohort 4 of the SunRISe-1 study show more than 95 percent of patients remained progression free at one year, with more than 92 percent not undergoing bladder removalPatients with this type of bladder cancer
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Benzinga Article ID:
49242702