HLB said on the 13th that a phase 3 clinical trial of the combination therapy of rivoceranib and camrelizumab, which is being developed as a liver cancer treatment, confirmed prolonged survival even in a group of patients with unresectable hepatocellular carcinoma. The company applied in May last year to the U.S. Food and Drug Administration (FDA) for approval of the combination as a first-line treatment for liver cancer.
The results will be presented by Elevar Therapeutics, HLB's U.S. subsidiary, at the European Society for Medical Oncology (ESMO 2025) to be held in Berlin, Germany, on the 17th (local time).
According to the released phase 3 post-hoc analysis abstract, the combination of HLB's rivoceranib and Jiangsu Hengrui Pharmaceuticals' camrelizumab extended both overall survival (mOS) and progression-free survival (mPFS), which refers to the average period the disease does not worsen, even in high-risk groups with extrahepatic metastasis and major vascular invasion.
In particular, among patients with extrahepatic metastasis, the mOS with the combination therapy was 23.5 months versus 13.0 months with sorafenib, the existing standard therapy, an extension of about 10 months. mPFS also showed a statistically significant difference, at 5.6 months for the combination and 3.6 months for sorafenib. In patients with major vascular invasion, the combination increased mPFS from 3.0 months to 5.5 months compared with sorafenib, confirming efficacy in high-risk patients.
In general, extrahepatic metastasis indicates a poor prognosis for advanced hepatocellular carcinoma, and major vascular invasion is closely associated with increased risk of recurrence and reduced overall survival. Adverse events were similar regardless of extrahepatic metastasis or major vascular invasion. The most common grade 3–4 adverse event with the combination was elevated liver enzyme (AST), while in the sorafenib group it was hand-foot syndrome.
Han Yong-hae, HLB Group chief technology officer (CTO), said, "The rivoceranib–camrelizumab combination has demonstrated meaningful survival extension while maintaining safety even in high-risk patients," adding, "These results provide evidence for its applicability as a first-line treatment across diverse clinical spectra of advanced liver cancer and hold important implications for future treatment guideline expansion and regulatory review."