Johnson & Johnson (JNJ, Financial) has announced the termination of its phase 2 trial for the TAR-200 therapy aimed at treating patients with muscle-invasive bladder cancer (MIBC). The decision followed an interim analysis from the SunRISe-2 study, which indicated no advantage over existing chemo-radiation treatments.
Despite this setback, the company remains committed to seeking FDA approval by early 2025 for TAR-200 as a monotherapy for non-muscle invasive bladder cancer (NMIBC). Johnson & Johnson expressed confidence in the TARIS platform's potential, forecasting sales exceeding $5 billion.
Bladder cancer is a common condition among the elderly, with a median diagnosis age of 70. It's a significant global health concern, with approximately 570,000 new cases annually. Of these, around 25% are MIBC, and 20% of high-risk NMIBC patients may progress to MIBC. MIBC has a relatively poor prognosis, with a five-year overall survival rate of 48%-70% with treatment, dropping to just 5% without.
Johnson & Johnson gained access to the TARIS platform, including TAR-200, through its acquisition of TARIS Biomedical in 2019. TAR-200 is an innovative intravesical drug delivery system that administers a localized, sustained, low-dose of Gemcitabine, a drug proven effective against various bladder cancers.
