Eleva Introduces Phase 3 Clinical Trial Results for Liver Cancer at Symposium Attended by MFDS Commissioner

HLB's U.S. subsidiary Eleba presented the Phase 3 clinical trial results of rivoceranib for liver cancer at the Pharmaceutical Bio Trends Symposium co-hosted by the Ministry of Food and Drug Safety (MFDS) and the Korean American Society of Pharmaceutical Professionals (KASBP).

The event began with an opening address by MFDS Commissioner Oh Yu-kyung, who was visiting the United States, followed by congratulatory remarks from KASBP President Jung Seung-won. In the first part of the event, key policies of the MFDS, core brand projects, regulatory trends for medical products, and efforts for regulatory harmonization were introduced. Subsequently, three major companies presented in areas including new drug development, hemodialysis, and CDMO.

Regarding new drug development, a presentation was made on the efficacy and safety of the “rivoceranib + camrelizumab combination therapy,” which completed a global Phase 3 trial last May across 13 countries including the U.S., Europe, and Asia for the development of a first-line treatment for liver cancer, and is currently preparing a New Drug Application (NDA) to the U.S. FDA.

Dr. Jang Sung-hoon, Chief Operating Officer (COO) of Eleba, who delivered the presentation, introduced, “The CARES 310 clinical trial is the first clinical result confirming high efficacy by combining a TKI inhibitor that effectively inhibits neovascularization in liver cancer treatment with an immune checkpoint inhibitor.” He added, “The median overall survival (mOS) of all patients was 22.1 months, the longest ever recorded, and if approved by regulatory authorities in the U.S. and other countries, it is expected to become an innovative liver cancer treatment.”

The combination therapy of the two drugs met statistical significance (P<0.0001) in all measures including the primary endpoint mOS, as well as secondary endpoints such as median progression-free survival (mPFS), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR).

Rivoceranib is an anticancer new drug substance for which HLB holds global patent rights. HLB Life Science holds Korean distribution rights and partial revenue rights for Europe and Japan. Hansoh Pharmaceutical holds the Chinese distribution rights, while Eleba holds overseas distribution rights for other regions.

HLB Life Science completed a conditional product approval application to the Korean MFDS in early February based on Phase 2 clinical trial results in the U.S. and Korea for salivary gland malignancy, specifically adenoid cystic carcinoma (ACC), and the MFDS review is currently underway.

The Korean American Society of Pharmaceutical Professionals, co-host of the event, is a non-profit organization established in 2001 to facilitate academic information exchange on major issues in the life sciences field including new drug development and to strengthen networking among its members.

Han Yong-hae, former president of KASBP, currently Chief Technology Officer (CTO) of HLB Group and CEO of HLB Life Science, introduced, “KASBP is an organization established to support new drug research and development through close cooperation with Korean pharmaceutical professionals and government-funded research institutes active in the United States.”

This content was produced with the assistance of AI translation services.