The government said it would grant insurance benefit to Eisai’s Lenvima (ingredient: Lenvatinib) as a first-line treatment for unresectable advanced hepatocellular carcinoma.
The drug is reimbursable when indicated as a monotherapy for advanced hepatocellular carcinoma patients, who are incapable of surgery or topical treatment and have stage III or higher, Child-Pugh class A, and Eastern Cooperative Oncology Group performance assessment 0-1.
Lenvima is a new first-line treatment option for advanced hepatocellular carcinoma in 10 years. Until now, Bayer’s Nexavar was only one treatment option approved for treating the disease.
The ministry approved the drug after the company proved the treatments improved treatment effects, such as progression-free survival, compared to Nexavar in a large-scale phase 3 clinical trial REFLECT study2.
The REFLECT trial on Lenvima evaluated the efficacy and safety of the drug, compared to Nexaba, in 954 patients with unresectable hepatocellular carcinoma in 20 countries.
Lenvima showed 2 percent complete remission, 38 percent partial remission, and 40.6 percent objective response rate (ORR) in the study, versus Nexavar’s ORR at 12.4 percent.
The Lenvima-treated group had 7.4 months in time to progression (TTP), whereas the Nexavar group had 3.7 months in TTP.
Based on the study, several international guidelines, including the European Association for the Study of the Liver (EASL), American Association for the Study of Liver Diseases (AASLD) and the European Society for Medical Oncology (ESMO,) have also recommended Lenvima, along with Nexavar, as a first-line treatment for non-resectable hepatocellular carcinoma.
The company is hoping that the reimbursement of Lenvima will provide new treatment options for patients.
“The reimbursement of Lenvima is meaningful as it presents new treatment options for patients with hepatocellular carcinoma who have long lacked treatment options,” Eisai Korea CEO Ko Hong-byung said. “The company hopes that the benefits will allow patients to relieve the burden of using new treatment options and benefit from Lenvima's excellent treatment.”
Korea Eisai will continue to make efforts to develop therapeutics and improve access to diseases that require treatment options, Ko added.