The European Commission (EC) has approved Bristol Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC).
“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,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “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.”
The decision is based on results from the CheckMate -9DW study, which were presented at the 2024 American Society of Oncology (ASCO) Annual Meeting, the 2024 European Society for Medical Oncology Congress and the 2025 ASCO Gastrointestinal Cancers Symposium. Results showed that dual immunotherapy treatment with Opdivo plus Yervoy led to a statistically significant and clinically meaningful improvement in overall survival (OS), the clinical trial’s primary endpoint.
In the trial, 85% of patients in the comparator arm were treated with lenvatinib and 15% were treated with sorafenib. The median OS was 23.7 months for Opdivo plus Yervoy compared to 20.6 months with the investigator’s choice of lenvatinib or sorafenib. The OS benefit was observed across clinically relevant patient subgroups. The trial also showed an overall response rate (ORR) of 36.1% compared to 13.2% of patients treated with lenvatinib or sorafenib and a deeper response with Opdivo plus Yervoy.
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.
