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FDA Grants Priority Review to Pembrolizumab/Lenvatinib Combination for Kidney Cancer

By: JNCCN 360 Staff
Posted: Wednesday, May 12, 2021

On May 6, the U.S. Food and Drug Administration (FDA) granted Priority Review for the PD-1 inhibitor pembrolizumab in combination with the tyrosine kinase inhibitor lenvatinib for the first-line treatment of patients with advanced renal cell carcinoma. Another application for the combination therapy given Priority Review is for patients with advanced endometrial carcinoma who have disease following prior systemic therapy in any setting and are not eligible for curative surgery or radiation therapy.

The FDA’s decision came after reviewing data from the multicenter, open-label, phase III CLEAR (KEYNOTE-581/Study 307) trial. The study tested the effectiveness of lenvatinib in combination with either pembrolizumab or everolimus compared with sunitinib for first-line treatment of patients with advanced renal cell cancer. A total of 1,069 patients randomly received one of the following regimens:

  • Lenvatinib at 20 mg orally once daily in combination with 200 mg of intravenous pembrolizumab every 3 weeks for up to 24 months
  • Lenvatinib at 18 mg orally once daily in combination with 5 mg of everolimus orally once daily
  • Sunitinib at 50 mg orally once daily for 4 weeks followed by 2 weeks off treatment.

The results showed statistically significant improvements in progression-free survival, overall survival, and overall response rate with the combination of pembrolizumab plus lenvatinib versus sunitinib.



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