Instant Report

Date: 27-Apr-2021

Eisai Merck Seek Japanese Approval For Additional Indication Of Lenvima In Combo With Keytruda To Treat Advanced Uterine Body Cancer

Eisai Co, Ltd and MSD K.K, a subsidiary of Merck & Co announced an application submission in Japan for the additional indication of Eisai’s in-house discovered and developed multiple receptor tyrosine kinase inhibitor, Lenvima (lenvatinib mesylate), in combination with Merck & Co’s Keytruda (pembrolizumab) as a treatment for patients with advanced uterine body cancer.

This application is based on the results of the pivotal phase 3 Study 309/KEYNOTE-775 for the treatment of patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen, which were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer in March 2021.

In this trial, Lenvima plus Keytruda demonstrated a statistically significant and clinically meaningful improvement in the primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS) as well as the secondary endpoint of Objective Response Rate (ORR) versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel). The safety profile of Lenvima plus Keytruda was consistent with previously reported studies.

Lenvima plus Keytruda has received orphan drug designation for a prospective indication for uterine body cancer by the Ministry of Health, Labour and Welfare, Japan (MHLW). Under this system, this application will be subject to priority review.

It is estimated that there were more than 417,000 new cases of uterine body cancer diagnosed worldwide and nearly 97,000 deaths from the disease in 2020. In Japan, there were more than 17,000 new cases and more than 3,000 deaths in 2020. Endometrial carcinoma is the most common type of uterine body cancer. It is considered that more than 90% of uterine body cancers occur in the endometrium. Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 17% for metastatic disease, the prognosis for these patients is poor.

Eisai and MSD have been collaborating through the provision of information on Lenvima in Japan since October 2018, and will work together to expedite the maximization of contribution by the Lenvima plus Keytruda combination therapy to patients with cancer.

Lenvima (lenvatinib mesylate)is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRa), KIT, and RET.

Keytruda (pembrolizumab) is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Study 309/KEYNOTE-775 is a multicenter, randomized, open-label, phase 3 trial (NCT03517449) evaluating Lenvima in combination with Keytruda in patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan) following at least one prior platinum-based regimen. The study met the dual primary endpoints of PFS, as assessed by BICR per RECIST v1.1, OS, as well as the secondary efficacy endpoint of ORR, as assessed by BICR per RECIST v1.1, in the all-comer population (pMMR and dMMR) and in the pMMR subgroup