Author : adminDate : 2020-08-13 10:24

HLB receives IND Approval for the Global Phase III of Primary Liver Cancer Treatment from KFDA

HLB announced that Hengrui Medicine and Elevar Therapeutics have been approved by the Korean Food and Drug Administration (KFDA) for IND for the global phase 3 clinical trial of the primary liver cancer treatment as a combination of Rivoceranib and Camrellizumab.


The clinical trials will be conducted on a total of 510 subjects, including those in China, the United States, Europe, and Taiwan, and Korea has been added this time. In Korea, the event will be held at 10 locations including Asan Medical Center, Samsung Medical Center, and Seoul National University Hospital.


The following test uses Overall Survival (OS) and Progressive-free Survival (PFS) of Camrelizumab and Rivoceranib as primary evaluation indicators and is conducted in a manner that contrasts with Sorafenib.


Camrelizumab is an immuno-cancer drug that suppresses Programmed cell Death-1 (PD-1), and Rivoceranib inhibits Vascular Endothelial Growth Factor Recorder-2 (VEGFR-2) to regulate neonatal inhibition, vascular normalization, and immune cell activity, so it is evaluated as an optimal combination of solid cancer treatment.


In particular, the results of this clinical trial are expected, as the complete limitation case of a liver cancer patient by a combination therapy drug was reported in Digestive and Liver Disease in October last year.


An HLB official said, "The overall patient registration rate was 23.5% in January this year and rapid patient registration has been shown with exceeding 50% of the current patient recruitment rate" and added, "With this IND approval in Korea, the progress will be accelerated."