Camrelizumab Plus Rivoceranib Shows Sustained Survival Benefit in Unresectable HCC

The combination of rivoceranib查看药品详情 and camrelizumab查看药品详情 continues to demonstrate a clinically significant survival advantage over sorafenib查看药品详情 in patients with advanced, unresectable hepatocellular carcinoma (搜索)搜索该疾病 (HCC (搜索)搜索该疾病). These findings, from the final analysis of the phase 3 CARES-310 trial, were presented at the 2024 ASCO Annual Meeting, reinforcing the potential of this combination as a first-line treatment option.

Sustained Overall Survival Benefit

At a median follow-up of 22.1 months in the combination arm and 14.9 months in the sorafenib查看药品详情 arm, the median overall survival (OS) was 23.8 months (95% CI, 20.6-27.2) for the camrelizumab查看药品详情 plus rivoceranib查看药品详情 group (n = 272) compared to 15.2 months (95% CI, 13.2-18.5) for the sorafenib group (n = 271). This translated to a hazard ratio of 0.64 (95% CI, 0.52-0.79; 1-sided P <.0001), indicating a significant reduction in the risk of death. Notably, the 24-month and 36-month OS rates were 49.0% and 37.7% for the combination, respectively, versus 32.6% and 24.8% for sorafenib.

Progression-Free Survival Improvement

The study also demonstrated a significant improvement in progression-free survival (PFS) with the combination therapy. The median PFS was 5.6 months (95% CI, 5.5-7.4) for the camrelizumab查看药品详情 plus rivoceranib查看药品详情 group compared to 3.7 months (95% CI, 3.1-3.7) for the sorafenib查看药品详情 group (HR, 0.54; 95% CI, 0.44-0.67; P <.0001).

Objective Response Rate and Safety

The objective response rate (ORR) was significantly higher in the combination arm, with 26.8% (95% CI, 21.7%-32.5%) of patients achieving a response compared to only 5.9% (95% CI, 3.4%-9.4%) in the sorafenib查看药品详情 arm. The median duration of response was 17.5 months (95% CI, 9.3-NR) for the combination group versus 9.2 months (95% CI, 5.3-NR) for the sorafenib group.

Safety data from the trial remained consistent with previous findings, with no new safety signals identified. Treatment-related adverse events (TRAEs) leading to discontinuation of camrelizumab查看药品详情 and rivoceranib查看药品详情 were 17.6% and 16.9%, respectively, in the combination group, with a 4.4% discontinuation rate for both agents. In the sorafenib查看药品详情 group, the discontinuation rate due to TRAEs was 4.8%.

Common TRAEs in the combination group included hypertension (69.5%), increased aspartate aminotransferase (AST; 54.8%), and proteinuria (49.6%). In the sorafenib查看药品详情 group, common TRAEs included palmar-plantar erythrodysesthesia (PPE) syndrome (61.0%) and diarrhea (39.4%).

Study Design and Patient Population

The CARES-310 trial was an international, randomized, open-label study that enrolled patients with unresectable or metastatic HCC (搜索)搜索该疾病, classified as Barcelona Clinic Liver Cancer (BCLC) stage B or C, who had not received prior systemic therapy. Patients were randomized 1:1 to receive either camrelizumab查看药品详情 (200 mg IV every 2 weeks) plus rivoceranib查看药品详情 (250 mg daily) or sorafenib查看药品详情 (400 mg twice daily).

The primary endpoints of the study were PFS and OS, with ORR as a key secondary endpoint. Key stratification factors included the presence of macrovascular invasion (MVI) or extrahepatic spread (EHS), geographic region, and baseline serum alpha-fetoprotein levels.

Expert Commentary

"The extended follow-up further confirmed the favorable benefit-to-risk profile of camrelizumab查看药品详情 plus rivoceranib查看药品详情, supporting it as a new first-line treatment option for unresectable HCC (搜索)搜索该疾病," said Arndt Vogel, MD, a professor of medicine at the University of Toronto and a clinician scientist at the Toronto Centre for Liver Disease.