FDA OKs Lenvima for First-Line Treatment of Liver Cancer

Lenvatinib (Lenvima) has been granted approval by the FDA as a first-line treatment for patients with unresectable hepatocellular carcinoma.

This article originally appeared on Targeted Oncology.

Lenvatinib (Lenvima) has been granted approval by the FDA as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC), based on data from the phase III REFLECT trial.

Findings from the trial, which were published in February 2018 in the

Lancet,

showed the multikinase inhibitor lenvatinib was noninferior to the established first-line standard of care, sorafenib (Nexavar). The median overall survival (OS) by investigator review with lenvatinib was 13.6 months compared with 12.3 months for sorafenib (HR, 0.92; 95% CI, 0.79-1.06).

Adding to these results, by investigator review, lenvatinib was superior to sorafenib for progression-free survival (PFS) and time-to-progression (TTP). The median PFS was 7.4 versus 3.7 months for lenvatinib and sorafenib, respectively (HR, 0.66; 95% CI: 0.57-0.77;

P

<.0001). TTP was 8.9 months for lenvatinib compared with 3.7 months for sorafenib (HR, 0.63; 95% CI, 0.53-0.73;

P

<.0001).

The REFLECT study randomized 954 patients with unresectable HCC to lenvatinib (n = 478) or sorafenib (n = 476). Lenvatinib was given at 8 mg per day for those weighing <60 kg and at 12 mg per day for those weighing ≥60 kg. Sorafenib was given at a 400 mg twice daily dose. The primary endpoint of the study was OS noninferiority.

Baseline characteristics were similar between the groups, with a median age of approximately 62 years and a predominant ECOG performance status of 0 (63%). The most common Child-Pugh class was A (99%) and 79% of patients had BCLC stage C disease. Twenty percent of patients had ≥3 sites of disease involvement, and half of patients had underlying hepatitis B infection. The median baseline AFP level was 133.1 ng/mL in the lenvatinib arm and 71.2 ng/mL in the sorafenib group.

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