Johnson & Johnson has announced that due to disappointing data, the company has halted Phase II study of TAR-200 therapy for patients with muscle-invasive bladder cancer (MIBC).
According to the Zhītōng Finance and Economics APP, Johnson & Johnson (JNJ.US) has stated that due to disappointing data, the company has terminated its Phase II study of the therapy TAR-200 for patients with muscle-invasive bladder cancer (MIBC). It is reported that the study named SunRISe-2 was halted after interim analysis of the data, as the analysis showed that this treatment method was not superior to radiotherapy and chemotherapy.
However, Johnson & Johnson stated in a declaration 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 sales potential of the TARIS platform, which exceeds 5 billion dollars."
Data shows that bladder cancer is a common disease among the elderly, with a median age of diagnosis at 70 years old. It is a serious public health burden, with approximately 0.57 million new cases of bladder cancer diagnosed globally each year. Among diagnosed cases of bladder cancer, approximately 25% are muscle-invasive bladder cancer (MIBC), and around 20% of high-risk non-muscle-invasive bladder cancer patients will progress to MIBC. Importantly, the prognosis for MIBC patients is relatively poor, with a 5-year overall survival rate (OS) of 48%-70% after treatment (5% for untreated patients), and untreated patients have a high risk of cancer-specific death in the near term.
In 2019, Johnson & Johnson acquired the TARIS Biomedical, obtaining the TARIS platform. TAR-200 is the primary clinical asset of this platform. TAR-200 is a novel bladder intracavity drug delivery system that provides sustained, low-dose local administration of Gemcitabine. Gemcitabine has been proven effective for various types of bladder cancer.