Bristol Myers Squibb announced that the European Commission has approved Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma. The EC's decision is based on results from the Phase 3 CheckMate -9ER trial, which demonstrated superior efficacy with Opdivo in combination with Cabometyx versus sunitinib across three key endpoints: progression-free survival, the primary endpoint, and objective response rate and overall survival. The combination of Opdivo and Cabometyx was well tolerated, with safety reflective of the known profiles of both medicines and a low rate of treatment-related adverse events leading to discontinuation. "With this approval, we can now offer patients two different Opdivo-based combinations that have demonstrated significant survival benefits versus sunitinib," said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. "Today's milestone builds on our heritage of developing and delivering novel treatments for patients with advanced renal cell carcinoma, first with the only dual immunotherapy option, Opdivo plus Yervoy, and now with a new immunotherapy and tyrosine kinase inhibitor regimen. We look forward to working with a broad range of European stakeholders to bring Opdivo in combination with Cabometyx to patients who may benefit from this treatment."