Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for kinase inhibitor Lenvima (lenvatinib) as the first-line treatment for patients with unresectable hepatocellular carcinoma (HCC).
The approval was based on data from Reflect study, which showed Lenvima’s treatment effect on overall survival (OS) by statistical confirmation of non-inferiority and also improved progression-free survival (PFS) and objective response rate (ORR) compared to sorafenib in patients with previously untreated unresectable HCC.
Discovered and developed by Eisai, Lenvima inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).
The treatment also showed antiproliferative activity in hepatocellular carcinoma cell lines dependent on activated FGFR signaling with a concurrent inhibition of FGF-receptor substrate 2α (FRS2α) phosphorylation.
Eisai Americas oncology business group commercial head Shaji Procida said: “Our goal is to bring monumental solutions to patients and health care providers, changing expectations for the oncology landscape, and we look forward to continuing this work in our ongoing collaboration with Merck.”
Reflect is a phase 3, randomized, multicenter and open-label trial carried out by Eisai to compare the efficacy and safety of lenvatinib against sorafenib as a first-line systemic treatment in patients with unresectable HCC.
The company recruited patients at 154 trial sites in 20 countries and randomized them to secure lenvatinib 12mg or 8mg once a day depending on body weight or sorafenib 400mg twice a day.
In February 2015, Lenvima first secured FDA approval to treat patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
In May 2016, Lenvima received FDA approval in combination with everolimus to treat patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy.
As part of the deal, Eisai and Merck started co-commercialization activities for Lenvima in the US in June this year.
Merck Research Laboratories chief medical officer, global clinical development head and senior vice president Dr Roy Baynes said: “We are pleased by the FDA approval of LENVIMA as it marks an important advancement in the treatment of unresectable hepatocellular carcinoma.”