FDA approves Lenvima in combination with Afinitor (lenvatinib + everolimus) for patients with advanced renal cell carcinoma- Eisai

The FDA has approved Lenvima (lenvatinib), from Eisai, in combination with Afinitor (everolimus) for the treatment of patients with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. This approval was based on the results of the registration study (Study 205), in which the once daily combination of 18 mg lenvatinib and 5 mg everolimus demonstrated an improvement in progression-free survival (PFS), objective response rate (ORR) and clinically meaningful overall survival (OS) when compared with everolimus alone, a standard of care for patients with aRCC who have received prior anti-angiogenic therapy.

In Study 205, a Phase II trial, lenvatinib and everolimus resulted in a median PFS nearly three times that of everolimus alone. The median PFS in patients treated with the combination (n=51) was 14.6 months compared with 5.5 months for everolimus alone (n=50). The combination regimen resulted in a 63% reduction in the risk of disease progression or death compared with everolimus alone. The treatment effect of the combination on PFS was supported by a retrospective independent review.

The objective response rate was 37% in patients treated with the combination regimen (35% partial response + 2% complete response) compared to 6% (all partial response) in patients treated with everolimus alone. The patients who received the combination experienced a 10.1-month increase in median OS compared with those who received everolimus monotherapy (25.5 months versus 15.4 months).

Comment: The combination was filed with the EMA in January 2016.