Johnson & Johnson announced additional results from its pivotal Phase 2b SunRISe-1 study, reinforcing the safety and efficacy of TAR-200, an investigational targeted releasing system for patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). The latest findings were presented during a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress (Abstract #LBA85).

“The compelling safety and efficacy results from the SunRISe-1 study further solidify the potential of TAR-200 as a novel treatment option for patients with high-risk bladder cancer,” said Dr. Michiel S. van der Heijden, M.D., Ph.D., medical oncologist at the Netherlands Cancer Institute. “These findings are particularly important for patients who do not respond to BCG immunotherapy and face life-changing procedures like radical cystectomy.”

In Cohort 2, TAR-200 monotherapy achieved a centrally-confirmed complete response (CR) rate of 83.5% in all 85 enrolled patients. The response was durable, with 82% of patients maintaining CR after nine months and an estimated 12-month CR rate of 57.4%. No reinduction was necessary, and the overall risk-benefit profile of TAR-200 monotherapy was favorable.

“We are committed to developing innovative therapies that reshape bladder cancer treatment,” said Dr. Christopher Cutie, Vice President, Bladder Cancer, Innovative Medicine at Johnson & Johnson. “The SunRISe clinical program results highlight the potential of TAR-200 to offer an outpatient, non-invasive treatment solution, transforming patient care in this space.”

Additionally, low discontinuation rates due to treatment-resistant adverse events (TRAEs) were reported with TAR-200 monotherapy. Common TRAEs included pollakiuria, dysuria, and urinary tract infection, with no treatment-related deaths.