Eisai has announced positive topline results from their Phase 3 trial of lenvatinib (Lenvima), for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Lenvima, a receptor tyrosine kinase inhibitor, is currently indicated to treat certain differentiated thyroid cancers and advanced renal cell cancer (RCC). The primary outcome of the latest Phase 3 trial (‘Study 304′) was non-inferiority to sorafenib in patients with unresectable HCC who had no prior systemic therapy.  

In total, 954 patients were included in the trial. They were randomized to receive lenvatinib 12mg or 8mg once a day, depending on body weight (n=478), or sorafenib 400mg twice a day (n=476). 

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The primary endpoint was achieved, with lenvatinib showing non-inferiority to sorafenib in overall survival. Also, statistically significant improvements were achieved in the secondary endpoints of progression-free survival, time to progression and objective response rate.

“The findings from this Phase 3 trial represent an important development for previously untreated patients with unresectable hepatocellular carcinoma who unfortunately face a poor prognosis,” said Alton Kremer, MD, PhD, CCO and CMO of Eisai.

In the study, the most common adverse events in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss, and fatigue. Eisai is continuing analyses of the remaining secondary endpoints of quality of life and plasma pharmacokinetics parameters, as well as safety.

For more information visit Eisai.com.