Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo^® (nivolumab) plus Yervoy^® (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in the European Union (EU).

“Hepatocellular carcinoma is the predominant type of liver cancer globally, including in the European Union, and when diagnosed at the advanced or unresectable stage, prognosis and overall survival remain sub-optimal with conventional therapy,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “The positive opinion received by the CHMP is a significant step forward in providing patients with additional treatment options, and we look forward to the upcoming European Commission review and the potential to expand the treatment landscape for adult patients with unresectable or advanced hepatocellular carcinoma.”

In June 2024, results were presented at the 2024 American Society of Oncology (ASCO^® ) Annual Meeting which showed statistically significant and clinically meaningful improvement in the clinical trial’s primary endpoint of overall survival (OS). In the trial, median OS was 23.7 months (95% CI: 18.8–29.4) for Opdivo plus Yervoy compared to 20.6 months (95% CI: 17.5–22.5) with the investigator’s choice of lenvatinib or sorafenib (HR: 0.79 (0.65–0.96); p=0.018). The OS benefit was observed across clinically relevant patient subgroups. 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.

In August 2024, the U.S. FDA also accepted the Company's supplemental Biologics License Application (sBLA) for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable HCC and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025. The combination of Opdivo plus Yervoy was granted accelerated approval by the U.S. FDA in 2020 based on results from the Phase 2 CheckMate -040 trial and has been an established second-line treatment for patients with advanced HCC.

Bristol Myers Squibb thanks the patients and investigators for their important contributions to the Phase 3 CheckMate -9DW clinical trial.