Eisai's lenvatinib meets in Phase II NSCLC trial

Eisai Co. Ltd. (Tokyo:4523) said once-daily oral lenvatinib ( E7080) plus best supportive care (BSC) met the primary endpoint vs. placebo plus BSC in a Phase II trial to treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC). Lenvatinib plus BSC led to median overall survival (OS) of 38.4 weeks vs. 24.1 weeks for placebo plus BSC (p=0.065). Lenvatinib plus BSC also met the secondary endpoint of improving median progression-free survival (PFS) vs. placebo plus BSC (20.9 vs. 7.9 weeks, p<0.001). The double-blind, international trial enrolled 135 patients with non-squamous NSCLC who failed at least two systemic anticancer regimens. Data are slated to be presented at the American Society of Clinical Oncology meeting.

This year, Eisai plans to submit regulatory applications for lenvatinib to treat radioiodine-refractory differentiated thyroid cancer in the U.S., Europe and Japan. Lenvatinib is also in Phase III testing for hepatocellular carcinoma (HCC) and Phase II testing for endometrial cancer, melanoma and glioma. Eisai could not be reached for next steps for lenvatinib in NSCLC. ...