FDA Approves Bristol Myers Squibb's Opdivo plus Yervoy as First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator's choice of lenvatinib or sorafenib1

In the trial, 38% of patients were still alive at 3 years with this dual immunotherapy vs. 24% with the comparator arm1

Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), the most common primary liver cancer.1,2 This approval is based on the results from the global Phase 3 randomized, open-label CheckMate-9DW trial evaluating the combination of Opdivo plus Yervoy compared to investigator's choice of tyrosine kinase inhibitor monotherapy (lenvatinib or sorafenib) in patients with unresectable or metastatic HCC who have not received prior systemic therapy.1 In the trial, Opdivo plus Yervoy demonstrated statistically significant overall survival (OS) and overall response rate (ORR) vs the comparator arm.1 It is the only trial supporting an FDA approval to show superior results against this comparator arm.