HLB Confirms Consistent Treatment Efficacy Across Age Groups in Liver Cancer Drug Analysis

HLB announced that the combination therapy of the new liver cancer drug "Rivoceranib + Camrelizumab" demonstrated consistent treatment efficacy regardless of age.

According to HLB on September 1, its U.S. subsidiary Elevar Therapeutics will present a poster featuring the post-hoc age subgroup analysis results of the global Phase 3 trial "CARES-310" for patients with unresectable hepatocellular carcinoma (uHCC) at the annual conference of the International Liver Cancer Association (ILCA 2026), which will be held from September 3 to 5 (local time) at the Le Plaza Hotel in Brussels, Belgium.

The results by age group showed that in patients under 50, the median overall survival (mOS) was 21.5 months, which is longer compared to 15.2 months in the sorafenib group, and the median progression-free survival (mPFS) was 5.5 months, an improvement over 2.7 months in the sorafenib group. In patients aged 50 and older, the mOS was 23.9 months versus 15.2 months, and the mPFS was 6.2 months versus 3.7 months, also demonstrating the efficacy of the combination therapy.

A similar trend was observed even among the younger patient group under the age of 40. The mOS for the combination group was 24.2 months, longer than the sorafenib group at 15.2 months, and the mPFS was 5.5 months, an improvement compared to 2.2 months in the sorafenib group.

No significant differences in safety were observed based on age. Treatment-related adverse events (TRAEs) were similar across all age groups. The most common grade 3 or 4 treatment-related adverse event in the combination group was hypertension, while in the sorafenib group it was hand-foot syndrome.

Arndt Vogel, Professor of Oncology at Princess Margaret Cancer Centre, University Health Network, University of Toronto, and corresponding author of this study, explained, "This age subgroup analysis provides additional evidence that the combination of camrelizumab and rivoceranib may improve treatment outcomes for liver cancer patients across a variety of age groups."

In July, Elevar received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the combination of rivoceranib and camrelizumab as a first-line treatment for liver cancer, due to cGMP-related matters at its manufacturing facility. The company is currently working with its partners to proceed with the resubmission process to the FDA.

Kim Donggeon, CEO of Elevar, stated, "The clinical data accumulated through CARES-310 consistently support the survival improvement potential of the combination therapy with rivoceranib and camrelizumab. Through this additional analysis, we have reaffirmed the treatment potential in a broad patient population, and we will do our utmost to provide new treatment options for patients with hepatocellular carcinoma through FDA approval."

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