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Merck and Eisai's Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive FDA's Third Breakthrough Therapy Designation as 1L Therapy for Hepatocellular Carcinoma

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Merck and Eisai's Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive FDA's Third Breakthrough Therapy Designation as 1L Therapy for Hepatocellular Carcinoma

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  • The third BT designation is based on P-Ib KEYNOTE-524 study assessing Keytruda (200mg- IV- q3w) + Lenvima (12/8 mg/day) in patients with unresectable HCC not amenable to locoregional treatment
  • The dual regimen has received its first two BT designation for advanced and metastatic renal carcinoma and non-microsatellite instability-high/proficient mismatch repair endometrial carcinoma in Jan’18 and Jul’18- respectively
  • Keytruda is an anti-PD-1 therapy blocking the interaction between PD-1 and its ligands- PD-L1 and PD-L2 thus activate T lymphocytes affecting both tumor & healthy cells. Eisai’s Lenvima is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR 1- 2 & 3

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Ref: Merck | Image: Merck


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