Robert J. Motzer, MD
The current standard-of-care therapy for patients with clear cell renal cell carcinoma (ccRCC) is sunitinib (Sutent), but many patients relapse or don’t have responses to the drug. In an attempt to find a targeted therapy to better serve these patients, investigators are assessing whether lenvatinib (Lenvima) combined with everolimus (Afinitor) or pembrolizumab (Keytruda) can outperform sunitinib. Either or both combinations may provide a survival benefit, which would add new options for treating the most common type of kidney cancer.
Figure. Lenvatinib Combinations in Frontline Clear Cell RCC
The trial will assess progression-free survival (PFS) as the primary endpoint, with overall survival (OS) and objective response rate (ORR) as the secondary endpoints.
gene mutation, which is targeted by VEGF inhibitors such as sunitinib and lenvatinib, so these drugs already have high efficacy in kidney cancers.
Prior Evidence of Efficacy
Prior studies have shown that both combinations have activity in RCC. In May 2016, the FDA approved the combination of lenvatinib and everolimus as a treatment for patients with advanced RCC following prior antiangiogenic therapy, based on survival and response data from a phase II study.4
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