Dr. Williams on the Rationale for the SunRISE-2 Trial in Muscle-Invasive Bladder Cancer

Stephen B. Williams, MD, chief, division of Urology, associate professor, Robert Earl Cone Endowed Professorship, director, Urologic Oncology, co-director, Department of Surgery Clinical Outcomes Research Program, University of Texas Medical Branch, discusses the rationale for the phase 3 SunRISE-2 trial (NCT04658862) in muscle-invasive bladder cancer (MIBC).

Oftentimes, patients with MIBC have a poor prognosis and are at a high risk of death, Williams explains. The standard-of-care approach for this patient population is neoadjuvant platinum-based chemotherapy, followed by radical cystectomy, which is associated with high treatment burden. However, previous studies have shown that a large portion of patients with MIBC receive no definitive treatment, Williams adds.

The intent of the SunRISE-2 trial was to explore the combination of TAR-200 (GemRIS) plus cetrelimab in patients with MIBC to determine whether it can improve outcomes, Williams adds. TAR-200 is a novel intravesical drug delivery system that enables sustained release of gemcitabine into the bladder and has demonstrated clinical benefit with favorable toxicity in this patient population, according to Williams.

Cetrelimab is an investigational immunoglobulin g4 antibody that targets the PD-1 receptor, blocking signaling for both PD-L1 and PD-L2, Williams says. Moreover, the study will specifically assess this modality of treatment vs concurrent chemoradiotherapy, Williams concludes.