The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence and disease progression are high. In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis. Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, accounts for approximately 90% of bladder cancer cases. Key secondary endpoints include overall survival, non-urothelial tract recurrence-free survival and disease-specific survival.īladder cancer is the 10th most common cancer in the world, with more than 573,000 new cases diagnosed annually.
#CHECKMATE 274 TRIAL#
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 tumor cells express PD-L1 ≥1%. A total of 709 patients were randomized 1:1 to receive Opdivo 240 mg or placebo every two weeks for up to one year. To date, Opdivo-based treatments have demonstrated clinically meaningful efficacy in four Phase 3 trials in earlier-stage cancers, including adjuvant bladder cancer, melanoma, esophageal/gastroesophageal junction cancer and neoadjuvant non-small cell lung cancer.īristol Myers Squibb thanks the patients and investigators involved in the CheckMate -274 clinical trial.ĬheckMate -274 is a Phase 3 randomized, double-blind, multi-center study evaluating Opdivo compared to placebo in patients with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery. Opdivo received approval for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of PD-L1 expression levels, in the United States in August 2021 and is currently undergoing regulatory reviews around the world.
Results from CheckMate -274 were first presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in February 2021 and published in the New England Journal of Medicine in June 2021. Opdivo was generally well tolerated, with a safety profile that was consistent with previously reported Opdivo studies in patients with solid tumors. Opdivo is the first and only immunotherapy to significantly improve the median time patients lived without disease recurrence in a randomized, placebo-controlled clinical trial in this setting. The positive opinion is based on results from the Phase 3 CheckMate -274 study, which demonstrated a statistically significant and clinically meaningful increase in disease-free survival (DFS) with Opdivo compared to placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1%. The CHMP’s positive recommendation brings us one step closer to providing patients in the European Union a chance to change the course of their disease at an early stage with an effective and tolerable adjuvant immunotherapy option.” “Based on the results of the CheckMate -274 trial, Opdivo is the first and only immunotherapy to significantly extend disease-free survival for high-risk patients with muscle-invasive urothelial carcinoma. Unfortunately, due to limited adjuvant treatment options, approximately 50% of patients experience recurrence despite enduring this significant surgery,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Undergoing radical resection for high-risk muscle-invasive urothelial carcinoma can have a major impact on a patient’s quality of life. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. If approved, Opdivo would be the first and only adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in Europeīristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection. Recommendation based on results from the Phase 3 CheckMate -274 trial, in which Opdivo significantly reduced patients’ risk of disease recurrence or death compared to placebo
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