Merck’s Keytruda (pembrolizumab) + Eisai’s Lenvima (lenvatinib) Receives FDA’s Approval for Certain Types of Endometrial Carcinoma

Merck’s Keytruda (pembrolizumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma


  • The approval is based on P-II KEYNOTE-146/Study 111 assessing Keytruda (200mg, IV, q3w) + Lenvima (20mg, PO, qd) in 108 patients with metastatic endometrial carcinoma that is not microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) with diseases progression following prior systemic therapy and are not candidates for curative surgery or radiation
  • The P-II KEYNOTE-146/Study 111 results: ORR (38.3%); CRR (10.6%); PRR (27.7%); median follow up time (18.7mos.). Under Project Orbis, Keytruda + Lenvima regimen is the first to receive simultaneous review decisions in the US, Australia and Canada
  • KEYTRUDA is an anti-PD-1 therapy, act by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2 thus activating T lymphocytes affecting both tumor and healthy cells. Lenvima is a kinase inhibitor targeting the activities of VEGF receptor including VEGFR1, VEGFR2 & VEGFR3

Click here to­ read full press release/ article | Ref: Merck | Image: Wsj