Johnson & Johnson’s Novel Intravesical Gemcitabine Shows Durable Response in BCG-Unresponsive Bladder Cancer

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Updated results from cohort 2 of the Phase IIb SunRISe-1 study of Johnson & Johnson’s (J&J) TAR-200 intravesical gemcitabine-releasing system demonstrated a promising 12-month duration of response (DOR) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). The system was particularly effective in patients with carcinoma in situ (CIS), with or without papillary disease.

Full results are set to be presented at the upcoming 2025 American Urological Association (AUA) Annual Meeting.¹

"Patients with bladder cancer need more effective treatment options that are both tolerable and easily incorporated into everyday practice, especially for those with HR-NMIBC, a highly recurrent disease that often necessitates difficult, life-altering decisions like bladder removal," said Yusri Elsayed, MD, MHSc. PhD, flobal therapeutic area head, oncology, Johnson & Johnson Innovative Medicine, in a press release. "TAR-200 provides a new approach, with clinical data showing an impressive complete response rate, meaning the cancer was undetectable following treatment. The highly anticipated 12-month duration of response findings from our Cohort 2, SunRISe-1 study further support the potential for patients to remain cancer-free for a clinically meaningful period."

The randomized, parallel-assignment, open-label SunRISe-1 study evaluated the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC patients with CIS who were ineligible for or declined radical cystectomy. Patients were randomly assigned across four different cohorts, with cohort 2 consisting of 85 patients treated with TAR-200 alone. The primary endpoint for cohorts 1-3 is complete response (CR) at any time point, with key secondary endpoints that include DOR, overall survival, pharmacokinetics, quality of life, safety, and tolerability.

Initial results showed a CR rate of 83.5%, reported to be highly durable without the need for reinduction. Additionally, 82% of patients maintained their response at a median follow-up of nine months. At one year, the CR rate was 57.4%, based on Kaplan-Meier analysis.

Patients in cohort 2 had a 6% discontinuation rate due to treatment-related adverse events (TRAEs). The most common TRAEs included pollakiuria, dysuria, hematuria, and urinary tract infections, with no treatment-related deaths reported.²

In addition to the updated cohort 2 results, updated results from cohort 4, which evaluated TAR-200 monotherapy in papillary-only HR-NMIBC will also be presented at the AUA meeting.¹

According to the American Cancer Society (ACS), bladder cancer is more common in men than in women. By the end of 2025, an estimated 84,870 new cases and 17,420 deaths are expected in the United States. Bladder cancer currently ranks as the 10th leading cause of cancer-related deaths in the country. However, death rates have been declining by about 1% per year since 2013, possibly due to earlier detection through increased awareness and improved treatment options, according to the ACS.³

Despite this trend, J&J notes that standard treatment approaches have undergone few changes in the past 40 years, leaving patients with limited alternatives when initial BCG therapy fails.¹

"Patients deserve more than the currently available treatment options. TAR-200 is a groundbreaking therapy for early-stage bladder cancer, designed to deliver a sustained local release of medication directly into the bladder—right where it is needed," said Biljana Naumovic, US president, oncology, solid tumor, Johnson & Johnson Innovative Medicine, in the press release. "This innovation provides a bladder-sparing treatment option that can meaningfully improve outcomes while integrating seamlessly into any urology practice."

References

1. Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AUA. PR Newswire. April 21, 2025. https://prnmedia.prnewswire.com/news-releases/johnson--johnson-unveils-highly-anticipated-and-potential-practice-changing-data-in-bladder-cancer-treatment-at-aua-302433399.html

2. New data from TAR-200 Phase 2b SunRISe-1 study show 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer. J&J. September 16, 2025. Accessed April 22, 2025. https://www.jnj.com/media-center/press-releases/new-data-from-tar-200-phase-2b-sunrise-1-study-show-84-percent-complete-response-rate-in-patients-with-high-risk-non-muscle-invasive-bladder-cancer?utm_source=chatgpt.com

3. Key Statistics for Bladder Cancer. American Cancer Society. Accessed April 22, 2025. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html