BMS receives European Commission approval for Opdivo + Yervoy with two cycles of chemotherapy for first-line treatment of metastatic NSCLC

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The combination of Opdivo plus Yervoy with two cycles of chemotherapy is the first dual immunotherapy-based treatment option approved for patients in the European Union (EU) with this disease. The EC’s decision is based on results from the Phase III CheckMate -9LA trial, which met its primary endpoint of superior overall survival (OS), as well as secondary endpoints of progression-free survival (PFS) and overall response rate (ORR), for the combination of Opdivo plus Yervoy, given concomitantly with two cycles of chemotherapy, versus chemotherapy alone. An improvement in duration of response (DoR) was also observed. The safety profile of Opdivo plus Yervoy and two cycles of chemotherapy was reflective of the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC. This decision marks the third indication for an Opdivo plus Yervoy-based regimen in the EU, following previous approvals in metastatic melanoma and advanced renal cell carcinoma (RCC). In addition to the EU, the combination of Opdivo plus Yervoy with two cycles of chemotherapy has been approved in 11 countries, including the U.S., for the first-line treatment of patients with metastatic NSCLC.