pembrolizumab plus lenvatinib (n=355) vs. sunitinib (n=357)
randomized controlled trial
lenvatinib plus pembrolizumab
LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (200 mg intravenously every three weeks)
sunitinib
Sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment)
3 arms : lenvatinib plus pembrolizumab, lenvatinib plus everolimus and sunitinib
metastatic/advanced RCC (mRCC) - 1st line (L1)
Karnofsky performance-status scoreof at least 70
open label
200 sites in 20 countries
P3/ two sided and two interim analysis. A sequential approach for multiple comparisons was used to adjust for multiplicity and to control the familywise error rate for progression-free survival and overall survival and the percentage of patients with an objective responseat the alpha of 0.0499 (two-sided) in comparisonsof each combination regimen with sunitinib.
The combination of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) significantly improved progression-free survival (PFS), overall survival (OS), and the objective response rate (ORR) compared with sunitinib (Sutent) as first line in patient with advancedrenal cell carcinoma