Lenvatinib-everolimus combination extends PFS in patients with mRCC versus everolimus alone

Eisai Inc. announced today results from an investigational Phase 2 trial which showed that lenvatinib, when used in combination with everolimus, significantly extended progression-free survival (PFS) in patients with metastatic renal cell carcinoma (mRCC) versus everolimus alone. The study met its primary endpoint of PFS as patients treated with the combination regimen (n=51) experienced a median PFS of 14.6 months compared with 5.5 months for those who received everolimus alone (n=50) (HR 0.40). When administered as a monotherapy, patients who received lenvatinib alone (n=52) experienced 7.4 months of PFS. These data will be presented in an oral session at the 51^st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Monday, June 1 at 11:45 a.m. CT (Abstract No. 4506).

"Additional treatments for metastatic renal cell carcinoma are needed for patients with this difficult-to-treat cancer," said Robert Motzer, M.D., Memorial Sloan Kettering Cancer Center, New York, and a principal investigator of the study. "These positive investigational study results show the potential role of lenvatinib in patients with metastatic renal cell carcinoma."

A total of 153 patients were enrolled in the open-label, multicenter study. Patients were previously treated with a VEGF-targeted therapy and randomized 1:1:1 to receive lenvatinib and everolimus (18+5 mg once a day), lenvatinib (24 mg once a day) or everolimus (10 mg once a day). Nearly all patients (99%) had received one prior VEGF-targeted therapy, 1% had received two prior VEGF-targeted therapies, and 18% had received prior immunotherapy treatment. For lenvatinib in combination with everolimus, the most common any-grade treatment-emergent adverse events (TEAEs) were diarrhea, decreased appetite and fatigue. The most common grade 3 or higher TEAEs were diarrhea, hypertension and fatigue.

"Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer and their families," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc.

The information discussed in this release presents an investigational use for lenvatinib. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that the investigational use of this FDA-approved product will successfully complete clinical development or gain FDA approval.