Princeton: Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

“We know that approximately 20% to 25% of patients diagnosed with urothelial carcinoma will experience disease metastasis, and an additional 5% of patients present de novo with metastatic disease. As a result, first-line treatment options that may offer these patients a chance for durable responses and improved survival outcomes are needed,” said Dana Walker, M.D., M.S.C.E., vice president, global program lead, genitourinary cancers, Bristol Myers Squibb. “We are pleased that the CheckMate -901 trial has displayed potential for Opdivo in combination with cisplatin-based chemotherapy to help address this unmet need and provide hope for patients and their loved ones. We are eager to continue working with the European Medicines Agency to discuss how we may bring this first-line regimen to appropriate patients across Europe.”
In the CheckMate -901 study, the first Phase 3 trial with an immunotherapy-based combination to show statistically significant and clinically meaningful survival benefit over standard-of-care cisplatin-based chemotherapy in the treatment of this patient population, Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR). The safety profile was tolerable and consistent with the known safety profiles of the individual components of the regimen. No new safety concerns have been identified. The OS and PFS data from CheckMate -901 were presented at the European Society for Medical Oncology (ESMO) Congress 2023.
Opdivo and Opdivo-based combinations have shown significant improvements in OS in Phase 3 clinical trials across multiple tumors, including metastatic urothelial carcinoma, advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma and esophageal squamous cell carcinoma.
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