Lenvima (ingredient: lenvatinib), a new liver cancer drug that arrived in a decade after Nexavar (sorafenib), is to enjoy insurance benefit in the first-line treatment of hepatocellular carcinoma, the health authorities said. Eisai Korea released Lenvima in Korea about a year ago.
|Eisai Korea’s hepatocellular carcinoma drug Lenvima|
The Health Insurance Review and Assessment Service (HIRA) said Monday that it would expand the reimbursement of Lenvima in the first-line treatment for patients with advanced hepatocellular carcinoma who cannot undergo surgery or topical treatment. If the pharmaceutical industry does not have any different opinion until Friday this week, the expanded reimbursement will start from Oct. 1.
Lenvima came out for the first-line treatment of advanced hepatocellular carcinoma when there was no other option except for Nexavar for more than 10 years.
Drug companies have tried to prove non-inferiority of numerous candidates to replace Nexavar but failed. Lately, immunotherapy Opdivo (nivolumab) attempted to do the same in vain.
However, Lenvima proved non-inferiority to Nexavar in overall survival and showed superiority to Nexavar in progression-free survival. Based on this, the drug won the local license last year.
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.
Masatoshi Kudo, a professor of Kindai University who was the chief researcher of the REFLECT study, said at the 2019 Gastrointestinal Cancers Symposium early this year that median overall survival was 22.4 months for the patients who responded to Lenvima, versus 11.4 months for non-responders.
“Since Japan approved Lenvima in March 2018, more than 8,000 people have already received the treatment, and nine percent of them used it for the first-line therapy,” Kudo said. “In Japan, most of the first-line treatment for advanced liver cancer has been replaced by Lenvima.”
Japan was the world’s first to grant the Lenvima license. The country authorized all other treatment options for second-line treatment, including Nexavar, Stivarga (regorafenib), and Cabometyx (cabozantinib), after the first-line treatment using Lenvima.