FDA approves Lenvima for unresectable hepatocellular carcinoma

The FDA approved lenvatinib capsules for the first-line treatment of patients with unresectable hepatocellular carcinoma.

The FDA based this approval of lenvatinib (Lenvima, Eisai) — a multiple receptor tyrosine kinase inhibitor — on the international randomized, open-label REFLECT trial. The analysis included 954 patients with previously untreated, metastatic or unresectable hepatocellular carcinoma.

Researchers randomly assigned patients 1:1 to receive lenvatinib — 12 mg orally once daily for patients 60 kg or heavier and 8 mg orally once daily for patients weighing less than 60 kg — or 400 mg twice daily sorafenib (Nexavar, Bayer) until radiological disease progression or unacceptable toxicity.

OS results showed lenvatinib appeared noninferior but not statistically superior to sorafenib (HR = 0.92; 95% CI, 0.79-1.06).

Median OS was 13.6 months among those assigned lenvatinib compared with 12.3 months among those assigned sorafenib.

Researchers observed significant improvement in PFS with lenvatinib compared with sorafenib (7.3 months vs. 3.6 months; HR = 0.64; 95% CI, 0.55-0.75).

When assessing for overall response rate using modified RECIST criteria for hepatocellular carcinoma, researchers observed a 41% rate among those treated with lenvatinib compared with 12% among those treated with sorafenib. ORR also appeared higher in the lenvatinib group when using RECIST 1.1 criteria (19% vs. 7%).

The most common adverse reactions observed among lenvatinib-treated patients included hypertension, fatigue, diarrhea, decreased appetite, arthralgia/myalgia, decreased weight, abdominal pain, palmar-plantar erythrodysesthesia syndrome, proteinuria, dysphonia hemorrhagic events, hypothyroidism and nausea.