Eisai Korea said Thursday that the Ministry of Food and Drug Safety approved Lenvima, the company’s kinase inhibitor, as the first line of treatment for unresectable hepatocellular carcinoma (HCC).

Various companies have been undergoing phase 3 clinical trials for hepatocellular carcinoma over the past decade, but all have failed, and only Sorafenib is available as a first line treatment.

As Lenvima finally proved comparable overall survival period against Sorafenib in a clinical trial, however, the company expects that the treatment will become a new hope for patients with liver cancer. The therapy also received approval as a first-line treatment for hepatocellular carcinoma in the U.S. and Europe in August.

Lenvima is a multiple kinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptor (VEGFR) 1-3, platelet-derived growth factor receptor (PDGFR-α), RET gene, KIT gene and fibroblast growth factor receptor.

Unlike conventional anticancer drugs, Lenvima inhibits FGFR together to produce more potent anti-cancer effects. Patients who weigh more than 60 kg receive 12 mg of Lenvima daily, while patients under 60 kg receive 8 mg.

The approval comes after the company released its results from REFLECT, an open-label, phase 3 trial where Lenvima demonstrated a treatment effect on overall survival (OS) by statistical confirmation of non-inferiority when compared with Sorafenib in 954 patients with previously untreated unresectable HCC.

The trial result showed that Lenvima achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to Sorafenib. Patients treated with Lenvima experienced a median OS of 13.6 months compared to 12.3 months with Sorafenib.

The treatment also demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (OBS).

The most common adverse effects in more than 20 percent of patients treated with Lenvima were hypertension, fatigue, diarrhea, and loss of appetite. Serious ill effects happened in 2 percent of the participants, which included hepatic encephalopathy (5 percent), hepatic failure (3 percent), ascites (3 percent) and loss of appetite (2 percent).

Eisai Korea said it plans to apply for extended insurance coverage as the medication received approval as the first-line treatment for unresectable hepatocellular carcinoma.

“We are delighted to be able to supply Lenvima to patients with hepatocellular carcinoma as it has proved efficacy and safety in phase 3 trials compared against Sorafenib,” Eisai Korea CEO Ko Hong-byung said. “We expect that Lenvima, which has excellent progression-free survival and objective response rate compared to Sorafenib, will meet the unmet medical need for patients with hepatocellular carcinoma.”

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