Johnson & Johnson has decided to discontinue its SunRISe-2 study, which was testing a new approach for treating muscle-invasive bladder cancer (MIBC) in patients who aren’t having a radical cystectomy.
The move follows a recommendation from an independent data monitoring committee after an interim analysis showed that the study didn’t outperform standard chemoradiation.
Even though the study didn’t go as planned, the company says it remains confident in TAR-200, its bladder cancer therapy. Data from the SunRISe-4 study, presented at the 2024 European Society for Medical Oncology Congress, showcased TAR-200’s potential to offer bladder-sparing treatment options, something critically needed for MIBC patients.
Johnson & Johnson is still on track to file for U.S. FDA approval of TAR-200 as a monotherapy for non-muscle invasive bladder cancer in early 2025. Meanwhile, the SunRISe-3 and SunRISe-5 studies are ongoing.
The company also says it continues to back the TARIS platform, projecting it could generate more than $5 billion in annual peak sales.
