Dr. Choueiri on FDA Approval of Lenvatinib Plus Everolimus in RCC

Toni K. Choueiri, MD, clinical director, Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, senior physician, Dana-Farber Cancer Institute, comments on the FDA approval of the combination of lenvatinib (Lenvima) and everolimus (Afinitor) as a treatment for patients with advanced renal cell carcinoma (RCC) following prior anti—angiogeneic therapy.

The approval is based on progression-free survival (PFS) and overall survival (OS) data from a phase II study, known as Study 205.

In the study, the combination of lenvatinib and everolimus reduced the risk of progression or death by 63% compared with the mTOR inhibitor everolimus alone. Median PFS with the combination was 14.6 versus 5.5 months with everolimus (HR, 0.37; 95% CI, 0.22-0.62). There was a 33% reduction in the risk of death with the combination versus the single-agent everolimus.