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Eisai and its partner Merck & Co have recently announced that they have submitted an application in Japan for the oral multi-receptor tyrosine kinase inhibitor Lenvima (Leweima, generic name: lenvatinib, lenvatinib).
This application is based on data from the key Phase 3 CLEAR study (KEYNOTE-581/Study 307).
CLEAR (NCT02811861) is a randomized, open-label phase 3 clinical trial that evaluated Keytruda+Lenvima, Lenvima+everolimus, and sunitinib as the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The results showed that Keytruda+Lenvima reached the primary endpoint (PFS) and key secondary endpoints (OS and ORR): In the intention-to-treat (ITT) study population, compared with the sunitinib group, the Keytruda+Lenvima treatment group was There were statistically significant and clinically significant improvements in PFS (HR=0.
The independent review was conducted according to the RECIST Version 1.
In the second experimental treatment group of the trial, the specific data are as follows: (1) In terms of PFS, the risk of disease progression or death in the Lenvima+ everolimus group was 35% lower than that in the sunitinib group (HR=0.
It is estimated that in 2020, the number of newly diagnosed kidney cancer cases worldwide will exceed 430,000, and the number of deaths from kidney cancer will be close to 180,000.
Lenvima+Keytruda combination therapy is part of the strategic cooperation between Merck and Eisai Oncology.
Lenvima is an oral multi-receptor tyrosine kinase (RTK) inhibitor with a novel binding mode.
Keytruda is an anti-PD-1 tumor immunotherapy that helps detect and fight tumor cells by improving the ability of the human immune system.
Currently, Merck and Eisai are conducting the LEAP (LEnvatinib and Pembrolizumab) clinical development project in 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-negative breast cancer) continue to study the Keytruda+Lenvima combination in 20 clinical trials.
Note: The original text has been deleted
Original source: appLICATION SUBMITTED FOR ADDITIONAL INDICATION OF ANTI CANCER AGENT LENVIMA? IN COMBINATION WITH KEYTRUDA AS A TREATMENT FOR ADVANCED RE
