Multinational randomized phase 2 trial of addition of TAR-200 to neoadjuvant cetrelimab for muscle-invasive bladder cancer in cisplatin-ineligible patients

TAR-200 is an investigational intravesical system that is designed to provide local release of gemcitabine in the bladder. The randomized phase 2 SunRISe-4 trial, at 109 centers in 10 countries, evaluated addition of TAR-200 to neoadjuvant cetrelimab (anti-PD-1) for newly diagnosed muscle-invasive bladder cancer in patients ineligible for or declining cisplatin-based neoadjuvant chemotherapy. The addition was associated with improved pathological complete response rate, with a manageable safety profile.