A late-stage trial assessing Eisai's cancer drug Lenvima for hepatocellular carcinoma (HCC) has achieved its primary endpoint, pushing the drug closer to being filed for approval in this setting.
The Phase III Study 304 compared the efficacy and safety of Lenvima (lenvatinib) versus Bayer's Nexavar (sorafenib), a standard treatment for advanced liver cancer, when used as a first-line of attack against unresectable HCC.
Data show that Lenvima met the statistical criteria for non-inferiority of overall compared to Nexavar, and showed statistically significant and clinically meaningful improvement for progression-free survival, time to progression and objective response rate.
On the safety side, the five most common adverse events observed in the Lenvima arm were hypertension, diarrhoea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of the drug, Eisai noted.
Analyses of the other secondary endpoints of quality of life and plasma PK parameters as well as safety are ongoing, but the firm said it plans to hold discussions with regulatory authorities for submission in Japan, the US, Europe and Asia, including China.
Liver cancer is the second leading cause of cancer related deaths, and is estimated to be responsible for approximately 700,000 deaths per year in the world. Nexavar is currently the only approved approved systemic first-line treatment for HCC, which accounts for around 85 percent to 90 percent of primary liver cancer cases, highlighting the need to new treatment options.