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 drug extends survival to 23.8 months
Chong Sae-ho, left, CEO of HLB’s U.S. subsidiary Elevar Therapeutics, poses with Arndt Vogel, professor at the University of Toronto’s Institute of Medical Science, during their meeting at Elevar Therapeutics’ booth at the American Society of Clinical Oncology annual meeting in Chicago, Saturday (local time). Courtesy of HLB
By Baek Byung-yeul
HLB revealed the Phase 3 clinical trial in the United States, saying the median overall survival (mOS) for patients treated with its liver cancer drug has been extended to 23.8 months from 22.1 months, the company said Tuesday.
HLB aims for U.S. Food and Drug Administration (FDA) approval for combination therapy of its Rivoceranib and Camrelizumab drugs from China's Jiangsu Hengrui Medicine.
At the American Society of Clinical Oncology's (ASCO) annual meeting, which took place from Friday to Tuesday in Chicago, the Korean bio company's U.S. subsidiary, Elevar Therapeutics, announced the clinical trial result.
HLB said that the new clinical results show the time from the start of the treatment to the patient's death has increased to 23.8 months, making a strong impression on the effectiveness of its new drug to doctors from various countries attending the event.
During the event, Chong Sae-ho, CEO of Elevar Therapeutics, discussed the Phase 3 results of the Rivoceranib combination therapy with researchers who conducted various detailed studies, including Arndt Vogel, a professor at the University of Toronto's Institute of Medical Science.
American liver cancer doctors predicted that the Rivoceranib combination therapy, given its conclusive results in terms of efficacy and safety, is likely to receive approval soon after completing the necessary supplementary items, HLB said.
Last month, the FDA rejected HLB's application for approval of the combination therapy. HLB attributed the rejection to issues related to chemistry, manufacturing and control at its partner company, China's Jiangsu Hengrui Medicine.
The company plans to meet with the FDA in July to identify and address the deficiencies and submit the necessary supplementary documents to obtain approval as a first-line treatment for liver cancer quickly.
"This updated result will be submitted to the FDA, and we expect it to significantly increase the authority's confidence in the drug's efficacy, which makes it very meaningful," a company spokesperson said.