HLB's "Lenvatinib Second-Line Liver Cancer Phase 3 Clinical Trial Results Published in World-Renowned Journal 'The Lancet'"

[Asia Economy Reporter Hyunseok Yoo] HL Biotech announced on the 11th that the Phase 3 clinical trial results of Lenvatinib (Chinese name Apatinib) for second-line liver cancer treatment were published on the 8th in the world-renowned medical journal, The Lancet.

Lenvatinib is a targeted anticancer drug that targets vascular endothelial growth factor receptor 2 (VEGFR-2). It was first marketed in China in 2014 as a third-line treatment for gastric cancer (brand name Aitan) and was approved in January this year as a second-line treatment for liver cancer. HL Biotech holds global rights and is currently conducting various global clinical trials, including NDA preparation for late-stage gastric cancer, first-line liver cancer, first-line salivary gland carcinoma, second-line gastric cancer, and third-line colorectal cancer.

The Phase 3 clinical trial, conducted on 400 patients at 31 hospitals in China, showed a median overall survival (mOS), the primary efficacy endpoint, of 8.7 months, demonstrating a significantly improved outcome compared to 6.8 months for the placebo group. Major side effects included hand-foot syndrome and thrombocytopenia, which were within manageable levels.

Liver cancer is the sixth most common cancer worldwide and ranks fourth in mortality. With a 5-year survival rate of 35.6%, which is only about half of the average cancer survival rate of 70.4%, the development of effective treatments is urgently needed.

Domestic bio company HL Biotech is conducting a global Phase 3 combination clinical trial of Lenvatinib and the immune checkpoint inhibitor Camrelizumab (PD-1 inhibitor) for first-line liver cancer treatment, with patient recruitment currently in the final stages. Both Lenvatinib and Camrelizumab are individually approved for liver cancer treatment in China, raising expectations for synergy between the two drugs.

Lenvatinib has been confirmed through research trials with Opdivo and Camrelizumab to enhance the efficacy of immune checkpoint inhibitors. It lowers the expression of the immune checkpoint PD-1 on cytotoxic T lymphocytes (CTLs) and promotes the secretion of immune-activating factors, thereby activating immunity within the tumor microenvironment and producing excellent effects when combined with immune checkpoint inhibitors.

Jang In-geun, Executive Director of Bio Planning and Strategy at HL Biotech, said, “Oral anticancer drug Lenvatinib is a differentiated treatment that improves patients’ quality of life with its convenience and superior efficacy. The published paper proves that Lenvatinib significantly improved patients’ overall survival, raising high expectations for the ongoing global Phase 1 liver cancer clinical trial.”

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