Johnson & Johnson Halts Phase II Trial of TAR-200 for Muscle-Invasive Bladder Cancer Due to Disappointing Data

Johnson & Johnson (JNJ.US) announced that it has halted the Phase II study of its therapy TAR-200 for treating patients with muscle-invasive bladder cancer (MIBC) due to disappointing data. The study, named SunRISe-2, was stopped after an interim analysis of the data showed that this treatment did not offer an advantage over chemoradiotherapy.

However, Johnson & Johnson stated in a press release that the company still plans to apply for FDA approval of TAR-200 as a monotherapy for non-muscle invasive bladder cancer (NMIBC) in early 2025. The company added: "We remain confident in the over $5 billion sales potential of the TARIS platform."

Data show that bladder cancer is a common geriatric disease, with a median age at diagnosis of 70 years, posing a significant public health burden. Globally, there are approximately 570,000 new cases of bladder cancer diagnosed each year. Among the diagnosed cases, about 25% are muscle-invasive bladder cancer (MIBC), and around 20% of high-risk non-muscle-invasive bladder cancer patients will progress to muscle-invasive bladder cancer. Importantly, the prognosis for patients with muscle-invasive bladder cancer is relatively poor, with a 5-year overall survival rate (OS) of 48%-70% after treatment (compared to only 5% without treatment). Patients who do not receive treatment face a high risk of cancer-specific mortality in the near term.

Johnson & Johnson acquired the TARIS platform in 2019 through the acquisition of TARIS Biomedical, with TAR-200 being the main clinical asset of this platform. TAR-200 is a novel intravesical drug delivery system that provides sustained, low-dose local delivery of Gemcitabine. Gemcitabine has been shown to be effective against various types of bladder cancer.

Editor: Chen Yujia