This is the only combination regimen to significantly prolong progression-free survival (PFS) when compared with a standard of care in patients with advanced renal cell carcinoma following prior anti-angiogenic therapy. Lenvima was designated as a Breakthrough Therapy by the FDA and also received a Priority Review, with approval obtained approximately six months after application submission.
The approval was based on a Phase II clinical study (Study 205)1 that compared the safety and efficacy of Lenvima alone, and in combination with everolimus, in patients with unresectable advanced or metastatic renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. From the results of the study, the group who received the combination of Lenvima plus everolimus demonstrated a significant extension in PFS, the study's primary endpoint, as well as a higher objective response rate compared to the everolimus alone group. The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher were diarrhea, hypertension and fatigue.
The number of patients with kidney cancer in the United States is estimated to be approximately 58,000,2 and renal cell carcinoma comprises more than 90% of all malignancies of the kidney.3 For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this is a disease with significant unmet medical need.
Lenvima was first approved for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer in the United States in February 2015, and has since been approved for thyroid cancer in over 40 countries including Japan, in Europe, South Korea and Canada. A new drug application seeking approval for an indication covering advanced or metastatic renal cell carcinoma submitted in Europe in January 2016 is under review, and Eisai intends to discuss further steps regarding submission strategies for this potential indication with the regulatory authorities in Japan as well. Furthermore, Eisai is conducting clinical studies of Lenvima in several other tumor types including a Phase III study of the agent in hepatocellular carcinoma.
Through this additional approval, Eisai is committed to maximizing the clinical value as well as exploring the potential clinical benefits of Lenvima in order to address the diverse needs of, and further contribute to, patients with cancer and their families.