Lenvima Plus Keytruda Approved in Taiwan as First-Line Treatment for Advanced Renal Cell Carcinoma

News on February 16, 2022 /BioValleyBIOON/ -- Eisai recently announced that the combination therapy of Lenvima (generic name: lenvatinib) and Keytruda (generic name: pembrolizumab) has been approved in Taiwan, China: for the first-line treatment of patients with advanced renal cell carcinoma (RCC).This approval marks the first approval of the regimen in the Asian region.. In this regimen, Lenvima is an orally administered multi-receptor tyrosine kinase inhibitor developed by Eisai, and Keytruda is an anti-PD-1 therapy developed by MSD.TumorImmunotherapy.

Lenvima+Keytruda is a"Targeted + Immunotherapy" Combination Therapy, which received approval from U.S. and EU regulatory agencies in August and November 2021, respectively, for the first-line treatment of adult patients with advanced RCC.

This approval is based on the pivotal Phase 3Clinical TrialCLEAR (Study 307/KEYNOTE-581) data. This trial evaluated the combination therapy in adult patients with advanced RCC. The results showed:Compared with Sunitinib, Keytruda + Lenvima showed statistically significant improvements in multiple efficacy endpoints (Overall Survival [OS], Progression-Free Survival [PFS], Objective Response Rate [ORR]).: (1) The risk of death was reduced by 34% (HR=0.66 [95% CI: 0.49-0.88]; p=0.0049); (2) The risk of disease progression or death was reduced by 61% (HR=0.39 [95% CI: 0.32-0.49]; p<0.0001), with a significant extension in PFS (median: 23.9 months vs 9.2 months); (3) ORR was significantly improved (71% vs 36%; p<0.001).

It is estimated that in 2020, there were over 430,000 newly diagnosed cases of kidney cancer globally, with more than 180,000 deaths. In 2018, Taiwan, China reported over 1,400 new cases and more than 600 deaths. Renal cell carcinoma (RCC) is by far the most common type of kidney cancer; approximately 90% of kidney cancer diagnoses are RCC. Most RCC cases are incidentally discovered during imaging tests for other abdominal conditions. About 30% of RCC patients present with metastatic disease at diagnosis, and up to 40% of patients will develop metastases after primary surgical treatment for localized RCC. The prognosis for these patients is poor, as survival rates heavily depend on the stage at diagnosis, which...DiagnosisFor patients with metastatic disease, the 5-year survival rate is only 12%.

The Lenvima+Keytruda combination therapy is part of the oncology strategic collaboration between Eisai and MSD. In March 2018, the two parties signed a cooperation agreement totaling up to 5.8 billion US dollars to develop Lenvima as a monotherapy and in combination with Keytruda for various types.TumorTreatment.

Keytruda is an anti-PD-1 cancer immunotherapy that helps detect and combat tumor cells by enhancing the ability 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 activating potentially impactfulTumorT lymphocytes of cells and healthy cells.

Lenvima is an orally administered multi-receptor tyrosine kinase (RTK) inhibitor with a novel binding mode, inhibiting not only factors involved in tumor angiogenesis but also those related to tumor progression andTumorIn addition to other pro-angiogenic and oncogenic signaling pathways related to immune-modified receptor tyrosine kinases (RTKs), including platelet-derived growth factor (PDGF) receptors PDGFRα, KIT, and RET, it can 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).

Currently, Eisai and MSD are conducting the LEAP (LEnvatinib And Pembrolizumab) clinical development program across more than 10 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, Pancreatic Cancer, and Triple-NegativeBreast Cancer) More than 20 itemsClinical TrialChina continues to study the Lenvima+Keytruda combination. Data from this program shows that the Lenvima+Keytruda combination has been used in various typesTumorDemonstrated strong efficacy in China. (Bioon.com)

Source of the original text:LENVIMA®（LENVATINIB）IN COMBINATION WITH KEYTRUDA®（PEMBROLIZUMAB）APPROVED IN TAIWAN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA