Bristol Myers Squibb Receives Favourable CHMP Opinion for Opdivo and Yervoy as First-Line Treatment for Advanced Liver Cancer in Adults
Saturday, February 01, 2025
Bristol Myers Squibb has 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) as a first-line treatment for adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This recommendation is based on findings from the Phase 3 CheckMate -9DW trial. The European Commission (EC) will now review the opinion and has the authority to grant approval for use within the European Union (EU).
Hepatocellular carcinoma is the most common type of liver cancer globally, including in the EU. When diagnosed at an advanced or unresectable stage, treatment options with conventional therapy have shown limited effectiveness in improving prognosis and overall survival. The positive opinion from CHMP represents progress in expanding treatment options for these patients.
In June 2024, results from the CheckMate -9DW trial were presented at the American Society of Oncology (ASCO) Annual Meeting. Findings demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), the primary endpoint of the trial. Median OS was reported as 23.7 months (95% CI: 18.8–29.4) for patients receiving Opdivo plus Yervoy, compared to 20.6 months (95% CI: 17.5–22.5) for those treated with lenvatinib or sorafenib, as chosen by investigators (HR: 0.79 (0.65–0.96); p=0.018). The OS benefit was consistent across different patient subgroups. The safety profile of the combination treatment was in line with previous data, and adverse events were managed using established protocols, with no new safety concerns identified.
In August 2024, the U.S. Food and Drug Administration (FDA) accepted Bristol Myers Squibb's supplemental Biologics License Application (sBLA) for Opdivo plus Yervoy as a potential first-line treatment for adult patients with unresectable HCC. The agency assigned a Prescription Drug User Fee Act (PDUFA) target review date of 21 April 2025. The combination treatment received accelerated approval in 2020 based on data from the Phase 2 CheckMate -040 trial and has been used as a second-line treatment for advanced HCC.
Bristol Myers Squibb acknowledges the contributions of patients and investigators in the Phase 3 CheckMate -9DW trial.
CheckMate -9DW is a Phase 3 randomised, open-label clinical trial comparing Opdivo plus Yervoy with lenvatinib or sorafenib monotherapy in adults with unresectable or advanced hepatocellular carcinoma who have not received prior systemic treatment.
The trial enrolled approximately 668 patients, who were assigned to receive either Opdivo plus Yervoy (Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks for up to four doses, followed by Opdivo monotherapy 480 mg every four weeks) or lenvatinib or sorafenib as oral treatment in the control group. The primary endpoint was overall survival (OS), with objective response rate (ORR) and time to symptom deterioration as key secondary endpoints.
Source: bms.com
