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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.
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The Courier-TribuneThe Courier-Tribune
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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

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Charleston Gazette-Mail broke the news in Charleston, United States on Saturday, April 26, 2025.
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