According to a press release from Eisai Inc. and Merck (also known as MSD), Lenvima®(lenvatinib) has been approved by the United States FDA as a first-line treatment for patients diagnosed with unresectable hepatocellular carcinoma. For more detailed information about this news, and the effects of Lenvima®, you can view the original source article here, on Merck’s website.
About Unresectable Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is a form of liver cancer that, according to the source article, accounts for approximately 90% of all primary liver cancer cases. HCC originates in liver cells known as hepatocytes and is more common in males, and as people get older. HCC is described as unresectable when the cancer cannot be completely removed through surgery. Unresectable HCC can be extremely challenging to treat, and there is a huge patient need for improved treatment options.
Lenvima is a kinase inhibitor drug. The US FDA first approved it for use in treating certain forms of thyroid cancer in 2015, and the following year it was also approved in the US as a combination treatment with the drug everolimus for certain groups with advanced renal cell carcinoma. Levima should only be used under guidance from a doctor.
The recent FDA decision to approve Levima for the treatment of unresectable HCC is informed by results from a clinical trial called Reflect.
About the Reflect Study
The Reflect trial, which is published in The Lancet (Vol 391(10126):1163-1173), was a Phase 3 clinical study that involved 954 participants with unresectable HCC. It was a randomised, open-label trial that compared lenvatinib and sorafenib as first-line systemic treatments. According to the source press release, lenvatinib was found to have a statistical non-inferiority in overall survival compared to sorafenib (a median of 13.6 months for lenvatinib versus 12.3 months for sorafenib). Additionally, lenvatinib was found to be statistically significantly superior and show clinically meaningful improvements compared to sorafenib for levels of progression-free survival and objective response rate.
For more detailed results from the study, you can view the original press release here.