HLB, Green Light for Pipeline Expansion After Liver Cancer Drug Approval

HLB announced on the 14th that the results of a combination therapy using Lenvatinib and drug-eluting beads transarterial chemoembolization (DEB-TACE) for patients with unresectable liver cancer were published in the medical science journal Nature.

Hepatocellular carcinoma (HCC) affects approximately 900,000 patients worldwide each year. Although drug development is actively progressing, there remains an urgent need for a broader range of treatment options. TACE therapy, which involves inserting a small catheter through the hepatic artery to deliver anticancer drugs and then blocking the blood vessels to kill cancer cells, continues to evolve as an effective treatment method.

The paper published in Nature introduced a large-scale investigator-initiated phase 3 clinical trial comparing a patient group (122 patients) treated with DEB-TACE containing Lenvatinib and cytotoxic chemotherapy agents to a patient group (121 patients) treated with DEB-TACE alone. When classified by liver cancer stage, 34% of the registered patients were BCLC-B, and 66% were BCLC-C.

Clinical results showed that the test group including Lenvatinib had a median progression-free survival (mPFS) of 7.1 months versus 5.2 months in the control group, a median overall survival (mOS) of 23.3 months versus 18.9 months, and an objective response rate (ORR) of 56.6% versus 38.8%. These results were statistically significant. Despite the high proportion (66%) of patients with more advanced tumors (BCLC-C), a clear improvement in survival prognosis was confirmed, indicating significant clinical importance.

The rates of metastasis to surrounding hepatic arteries or lungs after treatment were also much lower in the test group, at approximately 6% and 9%, respectively, compared to nearly 15% and 20% in the control group. Side effects associated with the addition of Lenvatinib were mild or manageable, including hypertension, hand-foot syndrome, and fatigue, which are commonly observed with anti-angiogenic agents.

Han Yonghae, CTO of HLB Group, stated, "Several small-scale clinical results have suggested that adding Lenvatinib or Lenvatinib plus Camrelizumab to TACE therapy improves patient survival prognosis. This clinical trial is a well-designed phase 3 study that comprehensively evaluated not only efficacy and safety but also the extent of metastasis, representing a high-quality research."