Eisai has announced clinically meaningful data from REFLECT, a pivotal Phase III study, which show that lenvatinib is non-inferior to sorafenib in median overall survival (OS) for the first-line systemic treatment of patients with unresectable hepatocellular carcinoma (uHCC).
These data were presented in an oral presentation at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) Chicago.
The REFLECT study (Study 304) is the first non-inferiority trial to show statistically significant results for a systemic therapy versus the current standard of care in uHCC, also demonstrating improvements in the secondary endpoints of progression-free survival, time to progression and objective response rate.
Hepatocellular carcinoma (HCC) is a complex disease associated with a poor prognosis, which accounts for approximately 90% of liver cancer cases worldwide.
The incidence of liver cancer in Europe has been rising steadily over the past decade. uHCC is an advanced hard-to-treat stage of liver cancer that affects >70% of patients.
HCC is the second most common cause of death from cancer worldwide, estimated to be responsible for nearly 746,000 deaths across the globe in 2012.
In Europe an estimated 71,000 people were diagnosed with liver cancer and 69,000 people died from the disease in 2012.
Professor Jeff Evans, Professor of Translational Cancer Research, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow and investigator of the study, said: “For a decade there has been no advance in the first-line systemic treatment of uHCC in Europe, so this data supports a potential new option for liver cancer patients that offers greater choice.”