Johnson & Johnson's Investigational TAR-200 Receives FDA Breakthrough Therapy Designation with 77% Complete Response Rate in High-Risk NMIBC

▎Edited by the WuXi AppTec content team

Johnson & Johnson recently announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to the investigational therapy TAR-200 for the treatment of high-risk non-muscle invasive bladder cancer (HR-NMIBC) patients who are unresponsive to Bacillus Calmette-Guérin (BCG) and are either ineligible for or opt against radical cystectomy.TAR-200 is an innovative targeted release system designed to provide sustained local delivery of gemcitabine into the bladder.

The supporting data for this designation came from the open-label phase 2b clinical trial, SunRISe-1. Results presented at the European Society for Medical Oncology (ESMO) Annual Meeting showed that among patients treated with TAR-200 monotherapy, the complete response rate confirmed by urine cytology and/or biopsy was 77% (95% CI, 58%-90%). Of the 23 patients who achieved a complete response, 21 maintained a sustained complete response, with 11 patients maintaining a complete response for six months or longer, and six patients maintaining a complete response for 12 months or longer. The median duration of response (DOR) was not reached.

TAR-200 is an investigational targeted release system that can control the release of gemcitabine in the bladder, maintaining local drug exposure for several weeks.

The safety and efficacy of TAR-200 are being evaluated in the Phase 2 and Phase 3 clinical trials, including SunRISe-2 and SunRISe-4 for the treatment of muscle-invasive bladder cancer, and SunRISe-1 and SunRISe-3 for the treatment of non-muscle-invasive bladder cancer.

The FDA’s Breakthrough Therapy Designation in the United States is a measure to expedite the development and regulatory review of drugs, granted to innovative therapies for the treatment of serious or life-threatening diseases. Based on preliminary clinical evidence, these therapies show the potential for significant improvement over existing treatments in one or more clinical endpoints.

References:

[1] Johnson & Johnson's Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer. Retrieved December 5, 2023, from https://www.prnewswire.com/news-releases/johnson--johnsons-investigational-tar-200-granted-us-fda-breakthrough-therapy-designation-for-the-treatment-of-high-risk-non-muscle-invasive-bladder-cancer-302005075.html

[2] TAR-200 Intravesical Delivery System Results Show 77 Percent Complete Response Rate in Patients with Bacillus-Calmette-Guérin Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer. Retrieved December 5, 2023, from https://www.jnj.com/tar-200-intravesical-delivery-system-results-show-77-percent-complete-response-rate-in-patients-with-bacillus-calmette-guerin-unresponsive-high-risk-non-muscle-invasive-bladder-cancer

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