March 29, 2021: “Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
“Even patients who appear disease-free after radical surgery for muscle-invasive urothelial carcinoma are at a high risk for recurrence, with around half of patients having their cancer return,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb.
“In the CheckMate -274 trial, Opdivo significantly reduced the risk of cancer recurrence or death, showing its potential to help address the need for safe and effective treatment options for this patient population.
We look forward to working with the EMA towards the goal of bringing the first adjuvant immunotherapy option to patients with muscle-invasive urothelial carcinoma in the European Union.”
The application is based on results from CheckMate -274, the first positive Phase 3 trial of an immunotherapy in this setting, which demonstrated increased disease-free survival (DFS) with Opdivo vs. placebo, regardless of patients’ PD-L1 expression levels. Opdivo was generally well tolerated, with a safety profile that was consistent with previously reported Opdivo studies in patients with solid tumors.
Results from the primary analysis of CheckMate -274 were presented in an oral presentation during the American Society of Clinical Oncology Genitourinary Cancers Symposium on February 12, 2021.
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -274 clinical trial.
About CheckMate -274
CheckMate -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.
A total of 709 patients were randomized 1:1 to receive Opdivo 240 mg or placebo every two weeks 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.
About Urothelial Carcinoma
Urothelial carcinoma, which most frequently begins in the cells that line the inside of the bladder, is the 10th most common cancer in the world, with approximately 550,000 new cases diagnosed annually.
In addition to the bladder, urothelial carcinoma can occur in other parts of the urinary tract, including the ureters and renal pelvis.
The majority of urothelial carcinomas are diagnosed at an early stage, but rates of recurrence and disease progression are high.
More than 50% of patients who undergo radical resection for muscle-invasive urothelial carcinoma will experience disease recurrence.
For patients whose disease recurs as metastatic cancer, the prognosis is poor, even with systemic treatment.”