HLB Presents Drug-Drug Pharmacokinetic Interaction Results at American College of Clinical Pharmacology

HLB announced on the 17th that it will present the pharmacokinetic results of drug interactions, including its targeted anticancer drug Rivoceranib, in the form of a poster at the American Society for Clinical Pharmacology and Therapeutics (ASCPT).

ASCPT is a society established to promote the social therapeutic benefits for patients and the advancement of clinical pharmacology and translational medicine. More than 2,000 experts participate annually to share knowledge and opinions in the field. This year, the event will be held in Atlanta, USA, from March 22 to 24.

The research paper, classified as a Late-Breaking abstract, involved Dr. Seonghoon Jang, Chief Operating Officer (COO) of HLB’s US subsidiary Elevar Therapeutics, along with Jeff Heckman and Bill Strickland as co-authors. The study was conducted to evaluate the potential risks of drug-drug interactions (DDI) related to ‘CYP3A4,’ the most important drug-metabolizing enzyme in the human liver, when Rivoceranib is taken together with other drugs.

HLB explained that this is part of the NDA preparation. Among the extensive application documents, data on interactions with various drug groups must be included for the labeling of the new drug. Since Rivoceranib is primarily metabolized by CYP3A4, the study investigated the extent of impact when taken with other drugs that inhibit CYP3A4’s metabolic activity. Individual results for concomitant drugs will be recorded in the labeling and are expected to serve as a guideline for dosing methods when Rivoceranib is taken with various drugs.

Last May, HLB completed a Phase 3 clinical trial of Rivoceranib combined with Camrelizumab for first-line treatment of liver cancer, involving 543 patients across 12 countries including the US, Europe, and Asia, and presented the results at ESMO 2022. The clinical results showed a median overall survival (mOS) of 22.1 months, demonstrating the highest efficacy to date and meeting the primary efficacy endpoint. Subsequently, a data cut-off was conducted again at the end of November last year, and preparations for the NDA submission in May are reportedly underway.

Seonghoon Jang, Vice President of Elevar, stated, "As announced by Hansoh Pharmaceutical, Elevar and Hansoh Pharmaceutical have formed a joint team to prepare the submission documents without delay, aiming for NDA submission in May." He added, "At the same time, we are communicating with numerous frontline medical professionals to establish sales strategies for rapid commercialization." He further said, "We will do our best to make the launch of the liver cancer treatment a catalyst for the revival of the Korean bio industry."