Impact of Age on Patient-Reported Outcomes with First-Line Camrelizumab plus Rivoceranib versus Sorafenib in Adults With Unresectable Hepatocellular Carcinoma: Post hoc Analyses of the CARES-310 Open-label, Randomized, Phase 3 Trial

Introduction: The CARES-310 randomized, open-label, international phase 3 trial reported improved overall survival and progression-free survival with camrelizumab–rivoceranib compared with sorafenib in adults with unresectable hepatocellular carcinoma (uHCC). Methods: We performed a post hoc analysis of data from CARES-310 to evaluate patient-reported outcomes (PROs), survival, and safety in adults <65 years and ≥65 years. PRO endpoints included time to deterioration with a ≥10-point decrease from baseline of health-related quality of life (HRQoL), physical functioning, role functioning, and symptoms. Results: PRO data for these age cohorts demonstrated clinically meaningful benefits with camrelizumab–rivoceranib versus sorafenib in key aspects of the patient experience such as HRQoL, functioning, pain and fatigue. Similarly, both age groups had a significant survival outcomes advantage on camrelizumab–rivoceranib versus sorafenib. Although patients treated with camrelizumab–rivoceranib had higher rates of treatment-related adverse events versus sorafenib, this did not adversely affect HRQoL as assessed by PROs. The most common ≥20% grade ≥3 treatment-related adverse events in the camrelizumab-rivoceranib arm were hypertension and increased AST versus palmar-plantar erythrodysesthesia syndrome in the sorafenib arm. Conclusion: These results support the favorable benefit-risk profile of camrelizumab–rivoceranib in patients <65 years and ≥65 years as a first-line therapy in patients with uHCC who have not received prior systemic therapy. ClinicalTrials.gov identifier: NCT03764293