Eisai's Lenvatinib A Success In Phase III Study
Eisai Inc. announced in a press release that its investigational drug lenvatinib showed success in a Phase III study. In the Phase III SELECT trial (Study 303), lenvatinib treated patients showed improvement in progression free survival (PFS) compared to a placebo. The SELECT study (Study of E7080 Lenvatinib in Differentiated Cancer of the Thyroid) was performed at multiple sites with a once daily dose of oral lenvatinib (24 mg). Eisai plans to proceed to marketing applications in the U.S., Europe, and Japan. Kenichi Nomoto, PhD, President of the Oncology Product Creation Unit in Eisai Product Creation Systems, said, "These results show the potential role of the investigational drug lenvatinib in this hard-to-treat cancer."
Radioiodine-Refractory Differentiated Thyroid Cancer
Radioiodine-refractory differentiated thyroid cancer (RR-DTC) is a type of thyroid cancer. Thyroid cancer rates are rising about six percent each year, making it the most common endocrine malignancy. Ninety percent of all thyroid cancers are differentiated thyroid cancers with specific cell morphology. Chemotherapy is often ineffective and toxic.
Lenvatinib
Lenvatinib (E7080) inhibits receptor tyrosine kinases (RTKs). These targets are VEGFR 1-3, FGFR 1-4, PDGFR-β, KIT, and RET, as they are associated with tumor proliferation. Eisai developed the drug and received Orphan Drug Designation (ODD) in 2012 in the U.S. for follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer. Eisai is pursuing clinical studies of the drug for other types of cancer.
The SELECT Study
In the SELECT study, investigators met the primary endpoint. Lenvatinib treated patients showed statistically significant improvement compared to the group taking a placebo; PFS improved. The secondary endpoints of overall response rate (ORR) and overall survival (OS) were met. The safety component of the study showed that patients experienced five main kinds of side effects. Participants reported nausea, decreased appetite, diarrhea, hypertension, and weight loss. The study was randomized and double blind and included 392 people at over 100 sites in global locations like Europe, Asia, and South America.
About Eisai Inc.
Eisai conducted the study with the SFJ Pharmaceuticals Group. Eisai is a pharmaceutical group based in Tokyo. The company is positioned to discover drugs, do clinical trials, manufacture, and market drugs. Eisai focuses on oncology, Alzheimer’s disease, metabolic conditions, and epilepsy.
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