Bristol Myers Squibb said CheckMate -274, a pivotal phase III trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met its primary endpoints of improving disease-free survival (DFS) versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1% (programmed death-ligand 1).
CheckMate-274 is the first and only phase III trial in which immunotherapy has reduced the risk of relapse in the adjuvant setting for these patients.
“With currently available therapies, more than 50% of patients with bladder cancer will experience recurrence after surgery, and each year, the disease takes the lives of nearly 200,000 patients,” said Matthew Galsky, professor of medicine, director of genitourinary medical oncology, director of the novel therapeutics unit, and co-director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai.
“Advances like immunotherapy have helped bring hope to patients across a growing number of cancer types, including previously treated advanced urothelial carcinoma. The positive results from CheckMate -274 point to the potential for nivolumab to become a new standard of care in the adjuvant setting, extending disease-free survival for post-surgery patients with muscle-invasive urothelial cancer without the use of chemotherapy.”
BMS plans to complete a full evaluation of the CheckMate -274 data, work with investigators to present the results at an upcoming medical conference, and submit the data to health authorities. The CheckMate -274 trial will continue as planned to allow for future analyses of secondary endpoints, including overall survival and disease-specific survival.
