Merck and Eisai have been granted breakthrough therapy designation from the US Food and Drug Administration (FDA) for their Keytruda and Lenvima combination for unresectable hepatocellular carcinoma (HCC).
The breakthrough therapy designation for the Keytruda, Lenvima combo is for the first-line treatment of patients with advanced unresectable HCC that is not responsive to locoregional treatment.
Keytruda is an anti-PD-1 therapy, which has been approved for multiple indications by the FDA, while Lenvima is an orally available kinase inhibitor discovered by Eisai. The kinase inhibitor was approved by the FDA in August 2018 as the first-line treatment for patients with unresectable HCC.
Lenvima blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).
Eisai vice president and oncology business group chief medicine creation and chief discovery officer Takashi Owa said: “We are excited that the FDA has recognized the potential of Keytruda plus Lenvima in combination in advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment with this Breakthrough Therapy designation.
“We are dedicated to working together with Merck to potentially bring another important option to patients.”
In March 2018, Merck and Eisai formed an oncology collaboration to jointly develop and commercialise Lenvima as a monotherapy and also in combination with Keytruda for the treatment of various types of cancer.
The combination of the two drugs already has two FDA breakthrough therapy designations, which are for advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma.
The third breakthrough therapy designation has been granted based on the results of the interim results from a phase 1b trial, called KEYNOTE-524/Study 116.
Merck Research Laboratories oncology clinical research vice president Jonathan Cheng said: “As part of our ongoing collaboration with Eisai, we are committed to evaluating the potential of Keytruda plus Lenvima across a number of different types of cancer.
“With this Breakthrough Therapy designation from the FDA, we look forward to working with Eisai to potentially build upon our existing indications for this difficult-to-treat cancer, so that we can help patients through a combination approach.”