Merck-Eisai's Keytruda/Lenvima Combo Scores Japanese Approval For Kidney Cancer Setting

The Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved Merck & Co Inc's MRK Keytruda/Lenvima combo therapy for radically unresectable or metastatic renal cell carcinoma (RCC). 

• Lenvima is an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai Co Ltd ESALY.
• Keytruda Plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC. 
• This marks the second approval of this combination in Japan; in December 2021, Keytruda/Lenvima combo was approved for unresectable, advanced, or recurrent endometrial carcinoma that progressed after chemotherapy.
• The approval is based on the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial. 
• Keytruda plus Lenvima demonstrated statistically significant improvements versus sunitinib in the primary efficacy outcome of progression-free survival (PFS). 
• Results showed Keytruda + Lenvima (n=355) reduced the risk of disease progression or death by 61%, with a median PFS of 23.9 months versus 9.2 months for sunitinib (n=357).
• Price Action: MRK shares are up 0.30% at $73.73 during the premarket session on the last check Friday.