Baek Byung-yeul is a journalist at The Korea Times focused on cultural content, including films and cultural events in South Korea. You can contact him at baekby@koreatimes.co.kr to share your insights.
HLB's liver cancer treatment shows longest overall survival
Researchers from HLB Group conduct research work in this photo, Thursday. Courtesy of HLB
By Baek Byung-yeul
By Baek Byung-yeul
Local biotech company HLB said its liver cancer treatment candidate Rivoceranib showed over 22 months of overall survival in its Phase 3 clinical trials, the longest in any liver cancer treatment, the company said, Thursday.
The company said it plans to hold a meeting with the U.S. Food and Drug Administration (FDA) to apply for approval for new drugs, given the effectiveness of its treatment has been proved in the clinical trials.
“The clinical trial of treatment for liver cancer using Rivoceranib and immune-cancer drug Camrelizumab recorded 22.1 months of mOS in Phase 3 clinical trials,” a HLB spokesman said. MOS refers to median overall survival, meaning the time from the start of the treatment to the death of the patient.
The company said it will announce the results and more details at the opening session of the European Society for Medical Oncology (ESMO) on Sept. 10.
The Phase 3 clinical trials were conducted on 543 patients in 13 countries including the United States, China, Korea, and European countries after the company earned approval from the FDA and other regulatory agencies to begin clinical trials.
HLB applied for a pre-new drug application (NDA) meeting with the FDA, which the company expects will take place within mid-October at the latest. Given both Rivoceranib and Camrelizumab received orphan designations from the FDA, the procedure is expected to proceed quickly, the company added.