Opdivo has now demonstrated clinically meaningful efficacy in the adjuvant treatment of three tumor types, including bladder cancer, melanoma and esophageal/gastroesophageal junction cancer
San Francisco, CA (UroToday.com) -- Bristol Myers Squibb announced that CheckMate -274, a pivotal Phase 3 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 3 trial in which immunotherapy has reduced the risk of relapse in the adjuvant setting for these patients. The safety profile of Opdivo was consistent with previously reported studies in solid tumors.
“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, M.D., 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.”“As we advance the science of immunotherapy, we’re discovering that these treatments may play an important role in earlier stages of cancer when the immune system is generally more intact and potentially more responsive,” said Mark Rutstein, Vice President, Opdivo Development, Bristol Myers Squibb. “With the positive results from CheckMate -274, Opdivo has now demonstrated improved efficacy in the adjuvant treatment of three tumor types, including bladder cancer, melanoma, and esophageal/gastroesophageal junction cancer, as part of our broad development program across earlier stages of cancer. We would like to thank the patients and investigators who participated in the trial and contributed to our collective scientific understanding.”
The company 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.
About CheckMate -274
CheckMate -274 is a Phase 3 randomized, double-blind, multi-center study evaluating Opdivo compared to placebo in participants with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery. Depending on patient characteristics, enrolled patients may or may not have received neoadjuvant chemotherapy prior to resection. A total of 709 patients were randomized 1:1 to receive Opdivo or placebo for up to one year. The primary endpoints of the trial are DFS in all randomized patients (i.e. the intention-to-treat population) and in the subset of patients whose tumors express PD-L1 ≥1%. Key secondary endpoints include overall survival, non-urothelial tract recurrence-free survival, and disease-specific survival.
Source: "Opdivo (Nivolumab) Significantly Improves Disease Free-Survival Vs. Placebo As Adjuvant Therapy For Patients With High-Risk, Muscle-Invasive Urothelial Carcinoma In Phase 3 Checkmate -274 Trial". 2020. News.Bms.Com.