Eisai and Merck's Lenvima plus Keytruda Approved in Japan for First-Line Treatment of Unresectable or Metastatic Renal Cell Carcinoma, Demonstrating Superiority Over Sunitinib

News on February 25, 2022 /BioValleyBIOON/ -- Eisai and its partner Merck & Co. recently announced jointly that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the oral multi-receptor tyrosine kinase inhibitor Lenvima (generic name: lenvatinib) in combination with the anti-PD-1 therapy Keytruda (generic name: pembrolizumab): for the treatment of patients with unresectable or metastatic renal cell carcinoma (RCC).

This approval marks the second approval of the regimen in Japan. In December 2021, the Lenvima+Keytruda regimen was approved for the treatment of patients with unresectable advanced or recurrent endometrial cancer (EC) whose disease has progressed after receiving anticancer chemotherapy.

This approval is based on the pivotal Phase 3Clinical TrialCLEAR (Study 307/KEYNOTE-581) data. The trial was conducted inFirst-line Advanced RCCThe combination therapy regimen was evaluated in adult patients. The results showed:Compared with the sunitinib treatment group, the Lenvima+Keytruda treatment group 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).

Renal Cell Carcinoma (RCC) is 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.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.

Lenvima is an orally administered multi-receptor tyrosine kinase (RTK) inhibitor with a novel binding mode, inhibiting not only factors involved in tumor angiogenesis and tumor progression but also...TumorIn addition to other pro-angiogenic and oncogenic signaling pathways related to immune-modified 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).

Keytruda is an anti-PD-1 tumor 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 impactful responses.TumorT lymphocytes of cells and healthy cells.

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 typesTumorShowed strong efficacy in China. (Bioon.com)

Source of the original text:LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) Approved in Japan for Radically Unresectable or Metastatic Renal Cell Carcinoma