Eisai Co. Ltd.'s Lenvima met its primary endpoint in a phase 3 trial as a first-line treatment of unresectable hepatocellular carcinoma, a common form of liver cancer.
The trial compared the efficacy and safety of Lenvima against the current standard of care sorafenib.
Eisai's anti-cancer agent met the criteria for non-inferiority compared to sorafenib in overall survival of patients, and showed statistically significant and clinically meaningful improvement in progression-free survival, time to progression and objective response rate.
The company plans to discuss Lenvima's submission with regulatory authorities in Japan, U.S., Europe and Asia, including China. The drug is currently approved for refractory thyroid cancer in over 50 countries, including the U.S. Japan, Europe, Korea, Mexico, and Brazil, and is undergoing regulatory review in countries including South Africa and Indonesia.
Eisai has obtained approval for the drug in the U.S. for an additional indication in combination with everolimus for the treatment of patients with advanced renal cell carcinoma after one previous anti-angiogenic therapy.
The drug was approved in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor targeted therapy in Europe. It has been launched in Europe under the brand name Kisplyx for this indication.
Eisai is also conducting trials for the drug in several other tumor types such as biliary tract cancer and in combination with pembrolizumab for various types of cancer. It has also started a phase III clinical study in combinations with both pembrolizumab and everolimus in renal cell carcinoma as a first-line therapy.