- Johnson & Johnson's TAR-200 achieved an 82.4% complete response rate in a Phase 2b trial for bladder cancer.
- 52.9% of patients who responded to TAR-200 remained cancer-free after one year.
- The treatment promises a median response duration of 25.8 months.
Johnson & Johnson (JNJ, Financial) has unveiled promising results from the Phase 2b SunRISe-1 study of its investigational bladder cancer treatment, TAR-200. Among the 85 patients enrolled, 82.4% achieved a complete response, indicating their cancer was undetectable post-treatment. Notably, 52.9% of these responders maintained their cancer-free status for at least 12 months, a significant achievement in the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle invasive bladder cancer (HR-NMIBC).
The study also revealed a median duration of response of 25.8 months, demonstrating long-lasting effectiveness of TAR-200. This intravesical gemcitabine releasing system, administered through a brief outpatient procedure, offers a potential bladder-sparing alternative for patients aiming to avoid radical cystectomy. Impressively, 86.6% of responders avoided cystectomy at the 12-month mark.
TAR-200's safety profile is encouraging, with 83.5% of patients experiencing mild urinary symptoms as the most common adverse events. Only 12.9% faced Grade 3 or higher adverse events. With these results, Johnson & Johnson has initiated a New Drug Application with the FDA under the Real-Time Oncology Review program, which could expedite the regulatory process for this promising therapy.
