NEW YORK – Bristol Myers Squibb on Thursday announced that its immune checkpoint inhibitor nivolumab (Opdivo) had demonstrated a significant disease-free survival benefit as an adjuvant treatment for patients with high-risk urothelial carcinoma, and that it will submit the positive data to regulatory agencies to garner approval in this setting.
BMS's plans are based on results from the Phase III CheckMate-274 trial, which randomized over 700 patients with high-risk bladder or upper urinary tract cancer to receive either nivolumab or placebo following radical surgery. The trial's primary aims were to assess disease-free survival both among all patients randomized and specifically among patients whose tumors expressed PD-L1 combined positive scores of at least one percent. According to BMS, the study met its primary endpoint in both subgroups.
After a full evaluation of the data, the company plans to present the results at an upcoming medical conference and to file the data with health authorities. The study will continue, however, so that the investigators can assess key secondary endpoints, such as overall survival.
"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," Matthew Galsky, an expert in genitourinary cancers at Mount Sinai, one of the trial's 187 study locations, said in a statement.
Nivolumab is already approved in the US for patients with advanced urothelial carcinoma who have previously received systemic therapy.