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 outcome 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.