Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising EGFR mutation or ALK translocation. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
Abderrahim Oukessou, VP, Thoracic Cancers Development Lead, Bristol Myers Squibb said, “We look forward to the EC’s decision and hope to soon introduce this innovative, dual immunotherapy approach to patients across the EU who may benefit.”
The CHMP adopted the positive opinion based on results from the Phase 3 CheckMate -9LA trial, which met the primary endpoint of superior overall survival (OS). 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. The full data from the CheckMate -9LA trial were featured in an oral session at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.
To date, the combination of Opdivo plus Yervoy with two cycles of chemotherapy has been approved in nine countries, including the U.S., for the first-line treatment of patients with metastatic NSCLC. Approval by the EC would mark the third indication for Opdivo plus Yervoy-based combinations in the EU, following previous approvals in metastatic melanoma and advanced renal cell carcinoma.