Shots:

• The approval is based on the P-III (CLEAR/KEYNOTE-581) study to evaluate Keytruda (200mg, IV, q3w for ~24mos.) + Lenvima (20mg, PO, qd) or Lenvima + everolimus vs sunitinib in a ratio (1:1:1) in 1069 patients with advanced RCC
• The results showed an improvement in efficacy outcome measures of PFS & OS with the reduction in risk of disease progression or death (61% & 34%); m-PFS (23.9mos. vs 9.2mos.); m-OS was not reached; ORR (71% vs 36%), CR rate (16% vs 4%); PR rate (55% vs 32%)
• The approval follows the marketing of Keytruda + Lenvima in 27 EU member states including Iceland, Liechtenstein, Norway & Northern Ireland. The combination therapy received the EC’s approval for 2 cancer i.e., advanced RCC & EC

 Ref: Businesswire | Image: Merck