If approved, Opdivo would be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in Europe
Application based on positive results from CheckMate -274, which showed that Opdivo nearly doubled disease-free survival and was well tolerated in these patients
Opdivo-based treatments have demonstrated efficacy in four Phase 3 trials in earlier-stage cancers, including bladder cancer, melanoma, esophageal/gastroesophageal junction cancer and non-small cell lung cancer
Bristol Myers Squibb today 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.