Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC
- Johnson & Johnson announced on April 26, 2025, that TAR-200 monotherapy achieved over 85 percent disease-free survival at six months in patients with BCG-unresponsive, high-risk papillary non-muscle-invasive bladder cancer.
- This interim report presents findings from the fourth cohort of the ongoing Phase 2b SunRISe-1 trial, focusing on patients who either cannot undergo or have chosen against radical cystectomy and were treated with the intravesical gemcitabine delivery system, TAR-200.
- Results showed 94 percent of patients preserved their bladder, with an early progression-free survival rate of 95.6 percent at nine months, and a safety profile consistent with prior studies.
- The most frequently reported treatment-related adverse events were dysuria in 40.4 percent of patients, followed by pollakiuria at 30.8 percent, and urgency affecting 26.9 percent. Additionally, 13.5 percent of patients experienced grade 3 events, with no deaths linked to the treatment.
- These findings suggest TAR-200 offers a tolerable, effective alternative to surgery for this high-risk bladder cancer population, supporting further evaluation in ongoing Phase 3 trials.
55 Articles
55 Articles

Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC
First results from SunRISe-1 (Cohort 4) show strong disease-free survival rates across high-grade papillary tumors, demonstrating the potential for bladder preservation with 94 percent of patients avoiding radical cystectomy
New Data From J&J’s Bladder Cancer Drug-device Trial Strengthens Support For NDA
Johnson & Johnson announced the new data during the American Urological Association’s (AUA’s) 2025 annual meeting in Las Vegas. Image credit: Shutterstock / Skorzewiak Johnson & Johnson (J&J) has reported more data supporting the efficacy of its intravesical drug release system TAR-200 in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Data, announced during the Paradigm-Shiftin…
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