J&J’s ‘Pretzel’ Combo Shines in Mid-Stage Bladder Cancer Trial

Johnson & Johnson recently announced promising results from its Phase IIb SunRISe-1 study, which evaluated the investigational drug-device combination TAR-200 in patients with high-risk non-muscle invasive bladder cancer (NMIBC). The findings were showcased at the American Urological Association’s annual meeting, highlighting the potential of TAR-200 to achieve rapid complete response in affected patients.

The study included 85 patients with high-risk NMIBC who had carcinoma in situ and were either not eligible for or refused radical cystectomy. The results revealed a complete response rate of 82.8%, confirmed through biopsies or urine cytology. Notably, nearly all complete responses occurred within 12 weeks of initiating treatment.

TAR-200 also demonstrated an estimated 1-year duration of response of 74.6%, with 85% of responders maintaining their complete response status as of January 2, 2024. Importantly, none of these patients progressed to muscle-invasive or metastatic disease, indicating a significant therapeutic benefit.

Christopher Cutie, Johnson & Johnson’s vice president and disease area leader for bladder cancer, emphasized the significance of these findings, describing them as a crucial step towards offering new treatment options that prioritize bladder preservation and long-term survival. Cutie highlighted the transformative potential of TAR-200 in treating NMIBC.

TAR-200 is designed for ease of use, allowing controlled dosing of the anti-cancer drug gemcitabine directly into the bladder. The drug-device system extends the bladder’s exposure to gemcitabine, enhancing its therapeutic effects. The installation process is straightforward, requiring only three to five minutes and can be performed in a physician’s office without anesthesia.

The SunRISe-1 trial is evaluating TAR-200 both as a monotherapy and in combination with cetrelimab, an intravenous PD-1 blocker. The study has enrolled 200 patients and aims to assess the complete response as its primary endpoint. Secondary outcomes include duration of response, overall survival, and quality of life.

In addition to SunRISe-1, Johnson & Johnson is conducting several other trials to explore the efficacy of TAR-200. These include Phase III studies SunRISe-3 and SunRISe-5 for NMIBC, as well as SunRISe-2 and SunRISe-4 for muscle-invasive bladder cancer.

This latest development marks another significant achievement for Johnson & Johnson in the realm of bladder cancer treatment. Earlier in January 2024, the company secured FDA approval for its FGF kinase inhibitor, Balversa (erdafitinib), for the treatment of locally advanced or metastatic urothelial carcinoma. Additionally, the FDA has recently approved ImmunityBio’s novel IL-15 superagonist Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin for NMIBC.

These advancements underscore Johnson & Johnson’s commitment to advancing bladder cancer treatment and improving patient outcomes. The promising data from the SunRISe-1 study reinforces the potential of TAR-200 as a valuable addition to the therapeutic landscape for high-risk NMIBC, offering hope for improved bladder preservation and long-term survival. 

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