Camrelizumab Plus Rivoceranib Boosts Survival Rates Over Sorafenib in uHCC

A final overall survival (OS) analysis of the phase 3 CARES-310 study demonstrated the efficacy of camrelizumab with rivoceranib for the treatment of unresectable hepatocellular carcinoma (uHCC). Arndt Vogel, MD, presented the data at the 2024 American Society of Clinical Oncology Annual Meeting.  

The trial is the first to demonstrate notable progression-free survival (PFS) and OS benefits through the use of immunotherapy paired with antiangiogenic tyrosine kinase inhibitors (TKIs) over standard TKIs as a first-line treatment for uHCC.

Initial results of CARES-310 showed significant improvements with camrelizumab plus rivoceranib in the study’s primary PFS and interim OS analyses.

The international, randomized, open-label trial involved 543 patients with uHCC who did not receive previous systemic treatment. Each patient was randomized to receive intravenous camrelizumab 200 mg every 2 weeks plus oral rivoceranib 250 mg once daily or oral sorafenib 400 mg twice daily. As of June 2023, 351 (65%) deaths occurred, and a protocol-specified final analysis was performed with an additional follow-up of 16 months.

Camrelizumab with rivoceranib was administered to 272 patients, while 271 patients received camrelizumab with sorafenib. At the data cutoff at final analysis, the median follow-up was 22.1 months in the camrelizumab plus rivoceranib arm and 14.9 months in the sorafenib arm.

Subsequent targeted therapy was administered to 36% of patients in the camrelizumab plus rivoceranib arm and 42% of patients in the sorafenib arm after the conclusion of study treatment; 17% and 36% of patients, respectively, received immunotherapy.

Camrelizumab plus rivoceranib was found to significantly prolong median OS rates over sorafenib (23.8 months [95% CI, 20.6-27.2] vs 15.2 months [95% CI, 13.2-18.5]; hazard ratio, 0.64 [95% CI, 0.52-0.79]; 1-sided P<.0001).

The OS rate with camrelizumab plus rivoceranib was 49.0% at 24 months versus 36.2% with sorafenib, and it was 37.7% versus 24.8% at 36 months. The OS benefit provided by camrelizumab plus rivoceranib was generally consistent across subgroups, regardless of geographical region, race, and etiology.

Benefits in PFS, objective response rate, and duration of response with camrelizumab plus rivoceranib were also sustained after prolonged follow-up. Safety data were consistent with the interim OS analysis, and no new signals were noted.

At final analysis, camrelizumab plus rivoceranib continued to show a manageable safety profile and clinically meaningful improvement in survival rates compared with sorafenib. Results remained consistent in the extended follow-up, supporting the treatment combination as a potential new first-line treatment option for uHCC.