On August 16, 2018, the FDA approved lenvatinib (Lenvima; Eisai) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
This approval was based on the multicenter, randomized, open-label, noninferiority REFLECT clinical trial of 954 patients with untreated metastatic or unresectable HCC. Patients were randomized in a 1:1 ratio to lenvatinib or to sorafenib (Nexavar) until radiologic disease progression or unacceptable toxicity.
The median overall survival was 13.6 months with lenvatinib versus 12.3 months with sorafenib (hazard ratio, 0.92; 95% confidence interval, 0.79-1.06).
The median progression-free survival with lenvatinib was 7.3 months versus 3.6 months with sorafenib (P <.001). The overall response rate was 41% with lenvatinib versus 12% with sorafenib.
The most common (≥20%) adverse events with lenvatinib were hypertension, fatigue, diarrhea, decreased appetite, arthralgia or myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia, hemorrhagic events, hypothyroidism, and nausea.