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FDA approves the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) for first-line treatment of advanced renal cell carcinoma (RCC)

On August 10, 2021, the Food and Drug Administration approved the combination of lenvatinib (Lenvima) plus pembrolizumab (Keytruda) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Pembrolizumab is an anti-PD-1 checkpoint inhibitor that helps the immune system detect and fight tumor cells. Lenvatinib is an anti-angiogenic targeted therapy that inhibits growth of tumors. This is the fifth combination treatment to be approved for the treatment of advanced kidney cancer.

The efficacy of this combination was investigated in CLEAR (Study 307/KEYNOTE-581; NCT02811861), a multicenter, open-label, randomized phase 3 trial in patients with advanced RCC in the first-line setting.

Progression-free survival (PFS) and overall survival (OS) were the major efficacy endpoints. Patients receiving pembrolizumab with lenvatinib had a median PFS of 23.9 months compared with 9.2 months for those receiving sunitinib. Median OS was not reached in either arm . The objective response rates were 71% and 36%; complete response rates were 16% and 4% on the combination and sunitinib arms, respectively. 

“New treatments offer hope for patients diagnosed and living with metastatic renal cell carcinoma,” said Dena Battle, President of KCCure. “This approval represents another step forward in the fight against kidney cancer. We are grateful to the patients who participated in this trial and helped make this new option a reality for all.”

For more information about treatment options available for advanced kidney cancer, click here.

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