(Seoul=News1) Reporter Moon Da-hyun – HLB (028300) announced on the 21st that the clinical results of its liver cancer drug under development have been published in the recent medical journal ‘The Lancet’.
In this clinical trial, the combination therapy of Rivoceranib and Camrelizumab was used perioperatively (before and after surgery) in patients with resectable hepatocellular carcinoma (HCC), resulting in more than double the period of survival without cancer recurrence or progression compared to surgery alone.
This clinical trial is the first to prove the effectiveness of the Rivo+Camrel combination therapy in early and mid-stage resectable hepatocellular carcinoma patients.
The company sees significant implications in these results, suggesting that the combination could expand as a treatment strategy applicable to all stages of liver cancer, beyond just the first-line treatment for advanced liver cancer.
The clinical trial, named CARES-009, was a multi-center, randomized Phase 2/3 study led by HLB’s Chinese partner Hansoh Pharma, targeting 294 patients with resectable hepatocellular carcinoma at moderate or higher risk of recurrence across 16 hospitals in China.
Patients were randomly assigned to either a surgery-alone group or a perioperative treatment group that received the Rivo+Camrel combination therapy before and after surgery.
As a result, the median Event-Free Survival (EFS), which was the primary endpoint, for the perioperative treatment group was 42.1 months, more than double that of the surgery-alone group at 19.4 months (HR 0.59, 95% CI 0.41-0.85; p=0.0040).
Moreover, the Major Pathological Response (MPR), a secondary endpoint, was found to be over four times higher in the perioperative treatment group at 35% compared to 8% in the surgery-alone group.
Grade 3 or higher treatment-related adverse events occurred in 38% of the perioperative treatment group, but this is a commonly reported type in combination therapies involving targeted therapy plus immunotherapy. The overall safety profile matched the level observed in previous studies.
The paper was particularly recognized for its clinical importance and academic value, being published early in the ‘Online First’ section of The Lancet’s website.
Yong-hae Han, HLB Group’s Chief Technology Officer (CTO), stated, “CARES-009 presents a new treatment option that surpasses the existing surgery-alone treatment in the field of liver cancer,” and added, “If the Rivo+Camrel combination therapy is extended for perioperative use, it can expand the market scope more than tenfold, serving as crucial evidence for future new drug approvals and global clinical strategy formulation.”
<Glossary>
■ MPR
The ratio of patients in whom less than half of the live cancer cells remain in the resected tissue, evaluated as a key indicator demonstrating the actual anti-tumor effect of pre-surgery treatment.