Johnson & Johnson's TAR-200 Shows Promising Durability Data for Bladder Cancer Treatment

Keywords

• TAR-200 (gemcitabine releasing system)
• Bladder cancer therapy
• BCG-unresponsive high-risk NMIBC
• "Pretzel" drug-device combo
• Complete response rate
• Disease-free survival
• Bladder preservation

Key Facts

Johnson & Johnson recently reported impressive durability data for its innovative bladder cancer treatment called TAR-200, a drug-device combination nicknamed the "pretzel drug." This silicone tube delivers low doses of gemcitabine directly to the bladder. The company has already filed a New Drug Application (NDA) with the FDA based on earlier promising results.

The latest data from the Phase 2b SunRISe-1 study showed:

• 82.4% complete response rate in patients with BCG-unresponsive high-risk NMIBC with CIS5
• 52.9% of responders remained in remission at one year5
• 86.6% of patients avoided bladder removal surgery (radical cystectomy) at one year5
• Median duration of response reached 25.8 months5
• Nine out of eleven patients who completed two years of treatment maintained their response5

Additional results from Cohort 4 of the SunRISe-1 study also demonstrated:

• Over 80% disease-free survival rate without requiring reinduction therapy2
• 94% bladder preservation rate among patients2
• 95% progression-free survival rate at 9 months2

TAR-200's complete response rate of 82.4% is reportedly the highest among currently available therapies for this condition, surpassing competing treatments like Anktiva (62%), Keytruda (41%), and Adstiladrin (51%)5.

These findings were presented at the 2025 American Urological Association Annual Meeting, where they were featured in the "Paradigm-Shifting, Practice-Changing Clinical Trials in Urology" plenary session, highlighting their potential significance for bladder cancer treatment2.

Sources:

2. https://www.jnj.com/media-center/press-releases/johnson-johnsons-tar-200-monotherapy-achieves-high-disease-free-survival-of-more-than-80-percent-in-bcg-unresponsive-high-risk-papillary-nmibc

5. https://www.fiercepharma.com/pharma/jj-aims-fundamentally-change-how-bladder-cancer-type-treated-immunitybio-plays-defense