TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence BARCELONA, Spain , Sept. 16, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ ) announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the pathological complete response (pCR) rate compared to CET alone in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and scheduled for radical cystectomy (RC). 1 These data were featured as a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress (Abstract #LBA84).

"These findings from the SunRISe-4 study show for the first time that an intravesical treatment with TAR-200, combined with a systemic PD-1 inhibitor, could potentially result in a complete pathological response in a high proportion of patients, as well as allowing a tolerable approach," said Andrea Necchi , M.D., of Italy's Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute and a presenting author of the study.

"These preliminary findings show a potential for a future change in the local treatment of muscle-invasive bladder carcinoma using TAR-200." In the interim analysis of the SunRISe-4 study, neoadjuvant TAR-200 plus CET (n=53) showed .