Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer

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Johnson & Johnson announced the initiation of a New Drug Application (NDA) submission to the FDA for TAR-200, an intravesical drug-releasing system designed for patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. According to the company, the NDA is supported by data from the Phase IIb SunRISe-1 study. The application will be reviewed under the FDA’s Real-Time Oncology Review program, which aims to expedite patient access to innovative treatments.¹

“Upon approval, TAR-200 promises to be a meaningful additional treatment option for certain patients with NMIBC, addressing a critical need for people who have had relatively limited therapeutic alternatives. Many patients face life-altering surgical options such as radical cystectomy, which is complete bladder removal,” said Yusri Elsayed, MD, MHSc, PhD, global therapeutic head, oncology, Johnson & Johnson Innovative Medicine, in a press release. “By combining our expertise in innovative medicine and medical devices, Johnson & Johnson is uniquely positioned to transform how we treat certain types of bladder cancer through the first and only intravesical drug releasing system for this disease. We look forward to working with the FDA in review of this application.”

SunRISe-1, cohort 2 was a randomized, parallel-assignment, open-label clinical study evaluating the safety and efficacy of TAR-200 monotherapy.¹ Consisting of 220 patients, the primary endpoint was complete response (CR) at any time, while secondary endpoints included duration of response, overall survival, pharmacokinetics, quality of life, safety, and tolerability.^1,2

Results found that TAR-200 demonstrated an 83.5% CR rate. Additionally, 82% of responders maintained a CR after nine months. At data cutoff, there was a 9% rate of grade 3 or higher treatment-related adverse events, with 6% discontinuing treatment as a result. Despite some patients discontinuing treatment, there were no deaths reported during the trial.¹

According to the American Cancer Society, bladder cancer accounts for approximately 4% of cancers in the United States. While it is the fourth most common cancer in men, it is less frequent in women. It is estimated that last year, there were around 83,190 new cases of bladder cancer diagnosed in the United States, with 16,840 deaths as a result; however, rates of bladder cancer have been dropping in recent years.

Bladder cancer is most common in older people, with every nine in 10 cases reported in patients over 55 years of age. The average age of development is 73 years of age. At the time of discovery, one in three bladders cancers will have already spread into deeper layers of the bladder wall but are still only in the bladder. In the remaining two out of three, the cancer will have spread to nearby tissues or lymph nodes outside the bladder. Five percent of newly discovered bladder cancers will have already spread to distant parts of the body.³

The FDA first granted Breakthrough Therapy Designation to TAR-200 for this indication in December 2023.¹

“TAR-200 represents a novel interventional approach for the treatment of localized bladder cancer where today, unfortunately, options are limited and include antiquated BCG therapy or radical cystectomy,” said Kiran Patel, MD, VP, clinical development, solid tumors, Johnson & Johnson Innovative Medicine, in a press release. “This Breakthrough Therapy Designation recognizes TAR-200 as a promising advancement and marks an important step forward in our innovative focus to transform the treatment of bladder cancer.”⁴

References

1. New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer. J&J. January 15, 2025. Accessed January 15, 2025. https://www.jnj.com/media-center/press-releases/new-drug-application-initiated-with-u-s-fda-for-tar-200-the-first-and-only-intravesical-drug-releasing-system-for-patients-with-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer

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. https://clinicaltrials.gov/study/NCT04640623

3. Key Statistics for Bladder Cancer. American Cancer Society. Accessed January 15, 2025. https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html

4. Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer. J&J. December 4, 2023. Accessed January 15, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnsons-investigational-tar-200-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-high-risk-non-muscle-invasive-bladder-cancer