Ph 3 SunRISe-2 trial in MIBC patients discontinued for not showing superiority versus chemoradiation
“The SunRISe-2 study in patients with muscle-invasive bladder cancer (MIBC) who are not receiving radical cystectomy was a bold approach to disrupt the established standard of care in chemoradiation in this difficult-to-treat population. Following an Independent Data Monitoring Committee recommendation and pre-specified interim analysis, SunRISe-2 was discontinued for not showing superiority versus chemoradiation. Based on data presented, we are highly confident in TAR-200 as a transformative therapy for bladder cancer where innovative and bladder-sparing options are urgently needed. Data from the SunRISe-4 study recently presented at the 2024 European Society for Medical Oncology Congress show the potential of TAR-200 in MIBC and we will continue to pursue approaches to advance care in this setting. We are on target for the U.S. FDA filing of TAR-200 monotherapy (SunRISe-1) in non-muscle invasive bladder cancer in early 2025 with the SunRISe-3 and SunRISe-5 studies underway.”
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