Bristol Myers Squibb has secured authorisation from the European Commission (EC) for the use of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line therapy for adult patients diagnosed with unresectable or advanced hepatocellular carcinoma (HCC).
The approval is based on findings from the CheckMate -9DW clinical trial, which demonstrated significant improvements in overall survival (OS) for patients administered the Opdivo-Yervoy combination.
Findings from the trial indicated a median OS of 23.7 months in patients receiving this dual therapy, compared to 20.6 months for those treated with either lenvatinib or sorafenib.
The hazard ratio stood at 0.79, with a p-value of 0.018, underscoring statistical significance. Additionally, an overall response rate (ORR) of 36.1% was noted, compared to 13.2% in the comparator group.
Bristol Myers Squibb vice president and Opdivo global programme lead Dana Walker said: “The European Commission’s approval for Opdivo plus Yervoy adds to the growing body of evidence demonstrating the value of dual immunotherapy and represents an important new treatment option that may extend survival for patients with hepatocellular carcinoma.
“This approval marks a critical milestone in our commitment to improving outcomes for patients with liver cancer. We look forward to bringing this new first-line treatment option to patients in the European Union.”
Opdivo is designed as an immune checkpoint inhibitor targeting programmed death-1 (PD-1), facilitating an enhanced immune response against tumors.
Yervoy acts as a monoclonal antibody that disrupts cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), aiding in T-cell activity regulation. In combination, these therapies stimulate T-cell activation and proliferation, enhancing anti-tumor responses.
This clearance by the European Commission extends across all EU member states and includes Iceland, Liechtenstein, and Norway. It complements existing approvals for Opdivo-based treatments targeting various tumour types across Europe.
Last August, the US Food and Drug Administration accepted Bristol Myers Squibb’s supplemental biologics license application for the combination as a potential initial treatment for adults with unresectable HCC. A Prescription Drug User Fee Act action date has been designated for 21 April 2025.
Previously, in 2020, accelerated approval was given by the FDA for this combination as a second-line treatment option for advanced HCC, informed by Phase 2 CheckMate -040 study outcomes.
