FDA approves KEYTRUDA plus LENVIMA for adults with advanced renal cell carcinoma

Aug. 16, 2021

Merck, known as MSD outside the United States and Canada, and Eisai announced that the U.S. Food and Drug Administration (FDA) has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Merck said the approval is based on results from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements versus sunitinib in progression-free survival (PFS), overall survival (OS) and confirmed objective response rate (ORR).

For PFS, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 61% with a median PFS of 23.9 months versus 9.2 months for sunitinib. For OS, KEYTRUDA plus LENVIMA reduced the risk of death by 34% versus sunitinib. Additionally, the confirmed ORR was 71% for patients who received KEYTRUDA plus LENVIMA versus 36% with sunitinib. KEYTRUDA plus LENVIMA achieved a complete response (CR) rate of 16% and partial response (PR) rate of 55% versus a CR rate of 4% and a PR rate of 32% for those who received sunitinib.

Patients were randomized (1:1:1) to one of the following treatment arms: LENVIMA (20 mg orally once daily) in combination with KEYTRUDA (200 mg intravenously [IV] every three weeks for up to 24 months); LENVIMA (18 mg orally once daily) in combination with everolimus (5 mg orally once daily); or Sunitinib (50 mg orally once daily for four weeks on treatment, followed by two weeks off treatment).

Visit Merck for more news

Photo 88130778 © Nataliia Mysik | Dreamstime.com
Photo 186155390 © Noipornpan | Dreamstime.com
Photo 171358238 © Nataliia Mysik | Dreamstime.com
Photo 84222773 © 7active Studio | Dreamstime.com
Photo 43618677 © Anupong Thiprot | Dreamstime.com