**Bristol Myers Squibb (BMS) has announced that its dual immunotherapy combination has been approved by the European Commission (EC) to treat hepatocellular carcinoma (HCC), the most common type of liver cancer.**
Opdivo (nivolumab) plus Yervoy (ipilimumab) has been authorised for use as a first-line treatment for adults with unresectable or advanced cases of the disease.
Liver cancer is the 6th most common cancer worldwide, with 866,136 diagnoses made in 2022 alone. HCC accounts for approximately 90% of all global cases and is often diagnosed at an advanced stage, at which point effective treatment options are limited.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by results from the late-stage CheckMate-9DW trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population.
Median overall survival was 23.7 months for Opdivo plus Yervoy compared to 20.6 months with lenvatinib or sorafenib, and this survival benefit found to be generally consistent across patient subgroups.
A statistically significant and clinically meaningful improvement was also observed in the secondary endpoint of objective response rate, which was 36.1% for Opdivo plus Yervoy compared to 13.2% with lenvatinib or sorafenib, and the safety profile for the combination was consistent with previously reported data, with no new safety signals identified.
Dana Walker, vice president, Opdivo global programme lead, BMS, said: “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 HCC… We look forward to bringing this new first-line treatment option to patients in the EU.”
The approval comes less than two months after BMS [shared](https://pmlive.com/pharma_news/bms-presents-promising-data-for-immunotherapy-combination-in-phase-3-colorectal-cancer-trial/) promising results from a late-stage study of Opdivo plus Yervoy in metastatic colorectal cancer (CRC).
Data presented at this year’s American Society of Clinical Oncology Gastrointestinal Cancers Symposium showed that the combination was associated with a statistically significant and clinically meaningful 38% reduction in the risk of disease progression or death compared to Opdivo monotherapy at a median follow up of 47 months in patients with microsatellite instability-high or mismatch repair-deficient metastatic CRC.