The European Commission (EC) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) in combination with the recombinant human monoclonal antibody Yervoy (ipilimumab) as a first-line treatment for adults with unresectable or advanced hepatocellular carcinoma (HCC).
This EC approval extends to all 27 European Union (EU) member states, including Liechtenstein, Norway and Iceland.
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It is supported by the positive outcomes from the open-label CheckMate -9DW trial, which demonstrated a meaningful overall survival (OS) improvement in individuals treated with the dual immunotherapy.
Subjects receiving the combo had a median OS of 23.7 months, against 20.6 months for those treated with the investigator’s choice of lenvatinib or sorafenib.
The overall response rate for the combination therapy was 36.1%, versus 13.2% for the comparator arm.
Bristol Myers Squibb Opdivo global programme lead and vice-president Dana Walker stated: “The EC’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 EU.”
The combo’s safety profile was consistent with previous data and manageable with established protocols, without any safety signals observed.
In August 2024, the US Food and Drug Administration (FDA) accepted a supplemental biologics licence application for this combo for the same indication, with a decision expected by 21 April 2025.
The combination had previously received accelerated approval in the US as a second-line treatment for advanced HCC, in 2020, based on the Phase II CheckMate -040 trial outcomes.
