Eisai's Oral Multikinase Inhibitor Lenvima (Lenvatinib) Granted Orphan Drug Designation in Japan for Uterine Body Cancer

March 21, 2021 /Bio ValleyBIOON/ -- Eisai recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to the oral multi-receptor tyrosine kinase inhibitor Lenvima (generic name: lenvatinib), for the treatment of uterine corpus cancer.

In Japan, there are approximately 30,000 patients with uterine corpus cancer. It is estimated that in 2020, there were 17,000 new cases and 3,000 deaths. More than 90% of uterine corpus cancers are believed to originate in the endometrium. Patients with advanced-stage endometrial cancer face high mortality rates and limited treatment options following initial systemic therapy.

Endometrial Cancer (Image source: womenworking.com)

Recently, at the 52nd Annual Meeting of the American College of Obstetricians and Gynecologists in 2021TumorAt the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, Eisai and its partner Merck & Co. presented for the first time the data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial (NCT03517449). The trial evaluated the efficacy and safety of the anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Lenvima in patients with advanced, metastatic, or recurrent endometrial cancer who had experienced disease progression following platinum-based chemotherapy.

Notably, the results presented at the conference were from a Phase 3 study of combination therapy regimens, including immunotherapy, for advanced endometrial cancer.Clinical TrialsFirst results: Compared with chemotherapy, the Keytruda + Lenvima regimen demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and overall response rate (ORR).

Specific data are as follows: In the overall study population, compared with chemotherapy, the Keytruda + Lenvima regimen: (1) reduced the risk of death by 38%, significantly prolonging overall survival (median OS: 18.3 months vs. 11.4 months), regardless of mismatch repair status; (2) reduced the risk of disease progression or death by 44%, significantly prolonging progression-free survival (median PFS: 7.2 months vs. 3.8 months); and (3) significantly improved the overall response rate (ORR: 31.9% vs. 13.7%).

Based on the aforementioned research data, Eisai and Merck & Co. are preparing to submit applications for a new indication of Keytruda + Lenvima in the treatment of endometrial cancer to regulatory authorities in countries worldwide, including Japan.

The Keytruda + Lenvima combination therapy is part of the strategic oncology collaboration between Merck & Co. and Eisai. In March 2018, the two companies signed a collaboration agreement worth up to $5.8 billion to develop Lenvima as monotherapy and in combination with Keytruda for multiple typesTumortreatment.

Lenvima is an oral multi-receptor tyrosine kinase (RTK) inhibitor with a novel binding mode, inhibiting not only those involved in tumor angiogenesis and tumor progression, andTumorIn addition to other receptor tyrosine kinases (RTKs) involved in angiogenic and oncogenic signaling pathways associated with immune modulation, including platelet-derived growth factor (PDGF) receptors PDGFRα, KIT, and RET, it can also selectively inhibit the kinase activity of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3, FGFR4).

Keytruda is an anti-PD-1 tumor immunotherapy that helps detect and combat tumor cells by enhancing the capacity of the human immune system. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activatingTumorT lymphocytes of cells and healthy cells.

Currently, Merck & Co. and Eisai are conducting the LEAP (Lenvatinib and Pembrolizumab) clinical development program across 13 different types of tumors (endometrial cancer, hepatocellular carcinoma,Melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, urothelial carcinoma, cholangiocarcinoma, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, and triple-negativeBreast Cancer) 20 itemsClinical Trialcontinue to study the Keytruda + Lenvima combination, including the Phase 3 trial LEAP-001 evaluating first-line treatment in patients with advanced endometrial cancer. Data from this program show that the Keytruda + Lenvima combination has been used in various typesTumorDemonstrated robust efficacy! (Bioon.com)

Original Source: MINISTRY OF HEALTH, LABOUR AND WELFARE GRANTS ORPHAN DRUG DESIGNATION IN JAPAN TO ANTI-CANCER AGENT LENVIMA® (LENVATINIB) WITH PROSPECTIVE INDICATION FOR UTERINE BODY CANCER