Merck and Eisai have announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) plus Lenvima (lenvatinib) to treat patients with certain types of endometrial carcinoma.
Keytruda is Merck’s anti-PD-1 therapy, while Lenvima is the orally available kinase inhibitor discovered by Eisai.
Keytruda plus Lenvima has been approved for the treatment of patients with advanced endometrial carcinoma, which is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
Keytruda is a humanised monoclonal antibody, which blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2. It may affect both tumour cells and healthy cells.
Lenvima is a kinase inhibitor, which blocks the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4).
Eisai chief discovery officer and chief medicine creation vice president Dr Takashi Owa said: “At least 75% of endometrial cancer cases are not microsatellite instability-high or mismatch repair deficient, and these women have been in need of new treatment options.”
The approval was based on data from KEYNOTE-146/Study 111, which is a phase 2, multi-cohort, multicentre, open-label and single-arm trial that recruited 108 patients with metastatic endometrial carcinoma that had progressed following at least one prior systemic therapy in any setting.
The patients have been treated with Keytruda 200mg intravenously every three weeks in combination with Lenvima 20mgrally once daily until unacceptable toxicity or disease progression as determined by the investigator.
According to the company, the major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) by the independent radiologic review committee (IRC) using RECIST 1.1.
Merck Research Laboratories oncology clinical research vice president Dr Jonathan Cheng said: “Today’s approval of the KEYTRUDA plus LENVIMA combination for advanced endometrial carcinoma that has progressed following prior systemic therapy brings the first approved combination treatment to women with this type of cancer whose tumors are not MSI-H or dMMR and who are not candidates for curative surgery or radiation, and demonstrates the potential of our collaboration with Eisai.”