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."