Johnson & Johnson's TAR-200 for Bladder Cancer Shows High Rates of Disease-Free Survival, Bladder Preservation

Credit: Sebastian Kaulitzki | stock.adobe.com

Early interim data from cohort 4 of the Phase IIb SunRISe-1 trial (NCT04640623) evaluating the novel bladder cancer treatment TAR-200 (Johnson & Johnson) in the treatment of Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC) show a disease-free survival (DFS) rate of 80%, with 94.2% of patients able to avoid bladder removal.^1,2 The promising findings for the investigational intravesical gemcitabine releasing system, presented at the 2025 American Urological Association Annual Meeting, demonstrate the potential of TAR-200 as a less invasive and effective alternative to surgery for patients with certain types of bladder cancer, according to trial investigators.

“The majority of patients remained free of cancer recurrence during this critical early study period, highlighting the potential of TAR-200 as a highly effective treatment for these patients who may have limited options beyond bladder removal,” presenting author Félix Guerrero-Ramos, MD, PhD, FEBU, head of Uro-Oncology at Hospital Universitario 12 de Octubre, Madrid, Spain, said in a press release. “As we continue monitoring patients through the 12-month mark and beyond, our focus remains on assessing TAR-200’s long-term efficacy in maintaining (DFS) and improving outcomes for this high-risk patient population.”¹

Current treatment recommendations for patients with NMIBC include radical cystectomy among those unresponsive to BCG therapy, which has a cancer-specific survival rate of 90% if performed prior to muscle-invasive progression. The disease typically manifests in older patients, many of whom may be unwilling or unable to undergo radical cystectomy. With high rates of recurrence and progression, NMIBC creates a significant risk of morbidity and distress for this patient population.²

The FDA granted Breakthrough Therapy Designation to TAR-200 for the treatment of BCG- HR-NMIBC in December 2023.³ The drug has an investigational targeted releasing system that allows for a controlled release of gemcitabine into the bladder, which can sustain local drug exposure over a period of weeks at a time, according to Johnson & Johnson. The drug’s safety and efficacy are being evaluated in patients with muscle-invasive bladder cancer across the SunRISe-2 and SunRISe-4 trials and NMIBC in the SunRISe-1 and SunRISe-3 trials.

Trial Design

The ongoing randomized, open-label, multicenter SunRISe-1 trial is analyzing the efficacy and safety of TAR-200 among 52 patients with BCG-unresponsive HR-NMIBC who are ineligible or unwilling to receive radical cystectomy. Patients assigned to cohort 4 had papillary-only disease and were administered TAR-200 monotherapy. This cohort’s primary endpoint is DFS rate at 12 months, with key secondary endpoints that included safety and tolerability.

Interim data show patients administered TAR-200 monotherapy achieved a DFS rate of 85.3% at six months and 81.1% at nine months, which is notable given the high rate of recurrence among these patients. In patients with high-grade Ta and T1 disease subtypes, DFS rates were 85.7% and 84.7% at six months, respectively, and 82.1% and 79.4% at nine months, respectively.

At nine months, progression-free survival was 95.6% and overall survival was 98%. Twelve-monthDFS data are not yet mature; however, the early data indicate the potential efficacy of TAR-200 in producing long-term disease control without the need for surgery, according to investigators.

In terms of safety, the profile of TAR-200 monotherapy was consistent with prior findings and no new safety signals were reported.

“Surgical removal of the bladder has long been the standard of care for patients suffering from BCG-unresponsive HR-NMIBC with papillary-only disease, a life-altering procedure that drastically impacts a patient’s quality of life,” said Christopher Cutie, MD, vice president, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine, in a press release. “These results demonstrate that TAR-200 can be a meaningful alternative to surgery that is both effective and well-tolerated while preserving the bladder.”¹

References

1. Johnson & Johnson’s TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC. News release. Johnson & Johnson. April 26, 2025. Accessed April 29, 2025. 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

2. A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1). ClinicalTrials.gov. Updated April 3, 2025. Accessed April 29, 2025. https://clinicaltrials.gov/study/NCT04640623

3. Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer. Johnson & Johnson. News release. December 5, 2023. Accessed April 29, 2025. https://www.jnj.com/johnson-johnsons-investigational-tar-200-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-high-risk-non-muscle-invasive-bladder-cancer