TAR-200 Combo Achieves Success in Mid-Stage Bladder Cancer Trial

Johnson & Johnson has recently reported new findings from its Phase IIb SunRISe-1 study, highlighting the efficacy of its experimental drug-device combination, TAR-200, for treating high-risk non-muscle invasive bladder cancer (NMIBC). The study's results were showcased at the annual meeting of the American Urological Association, revealing an impressive complete response rate of 82.8% among 85 patients with carcinoma in situ who are either not suitable candidates for or have declined radical cystectomy. Remarkably, almost all of these responses were achieved within a 12-week treatment period.

The SunRISe-1 study also projected a 1-year duration of response at 74.6%, with 85% of the patients maintaining a complete response as of the January 2, 2024 data cutoff. Importantly, none of these patients experienced progression to more severe stages of the disease. Christopher Cutie, a leader at J&J, celebrated these results as a significant advancement in offering new treatment options that focus on bladder preservation and long-term patient survival.

TAR-200 is an innovative targeted drug delivery system that provides a controlled release of gemcitabine into the bladder, enhancing the organ's exposure to the medication. The device is designed for ease of installation, requiring only 3 to 5 minutes for the procedure, which can be performed in a physician's office without the need for anesthesia.

In the SunRISe-1 trial, TAR-200 is being evaluated both as a single therapy and in combination with the intravenous PD-1 blocker cetrelimab. The trial has enrolled 200 patients with the primary goal of assessing complete response. Secondary outcomes include the duration of response, overall survival, and life quality.

Johnson & Johnson is also conducting Phase III studies, SunRISe-3 and SunRISe-5, for TAR-200 in NMIBC, along with SunRISe-2 and SunRISe-4 for muscle-invasive bladder cancer. This recent update from the SunRISe-1 study marks another milestone for J&J in the field of bladder cancer treatment, following the FDA approval of its FGF kinase inhibitor Balversa (erdafitinib) for locally advanced or metastatic urothelial carcinoma in January 2024. Additionally, the FDA has approved ImmunityBio’s novel IL-15 superagonist Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin for the treatment of NMIBC.