European Commission approves Lenvima to treat hepatocellular carcinoma (liver cancer)- Eisai + Merck Inc.

Eisai Co., Ltd.and Merck & Co., Inc.,announced that the European Commission (EC) has granted a marketing authorization for the oral receptor tyrosine kinase (RTK) inhibitor Lenvima (lenvatinib mesylate) as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy. This is the first new first-line treatment option for advanced or unresectable HCC to be approved in Europe in approximately 10 years.

This approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a treatment effect on overall survival (OS) by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR) when compared with sorafenib in patients with previously untreated unresectable HCC.

REFLECT showed that Lenvima achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with Lenvima experienced a median OS of 13.6 months compared to 12.3 months with sorafenib (Hazard Ratio (HR): 0.92; 95% Confidence Interval (CI): 0.79-1.06). The OS analysis was conducted as prespecified in the statistical analysis plan when 351 events had occurred in the Lenvima arm and 350 events had occurred in the sorafenib arm. Regarding secondary efficacy endpoints, according to independent imaging review based on mRECIST criteria, Lenvima showed statistically significant superiority and clinically meaningful improvements as compared to sorafenib in median PFS: Lenvima 7.3 months versus sorafenib 3.6 months (HR: 0.64; 95% CI: 0.55�0.75; p<0.0001) and orr: lenvima41 versus sorafenib 12 p><0.0001).>