Bristol Myers says Phase 3 CheckMate -9DW trial met primary endpoint

Bristol Myers Squibb announced the Phase 3 CheckMate -9DW trial evaluating Opdivo, or nivolumab, plus Yervoy, or ipilimumab, as a first-line treatment for patients with advanced hepatocellular carcinoma, or HCC, who have not received prior systemic therapy met its primary endpoint of improved overall surviva, or OS, compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis. The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. The company will complete a full evaluation of the data and work with investigators to share the results with the scientific community at an upcoming medical conference, as well as discuss with health authorities.