Summary of Research: Health-Related Quality-of-Life Profile and Clinical Outcomes in First-Line Advanced Renal Cell Carcinoma: A Modeling Analysis Based on the CheckMate 9ER Study

This is a summary of a post hoc analysis of the phase 3 CheckMate 9ER study. CheckMate 9ER demonstrated a significant improvement in progression-free survival and overall survival with first-line cabozantinib plus nivolumab (CaboNivo) versus sunitinib (SUN) in patients with advanced renal cell carcinoma. First-line CaboNivo also maintained or improved health-related quality of life (HRQoL) versus SUN. However, the relationship between clinical efficacy and patient treatment experience remains underexplored. This post hoc analysis investigated the relationship between changes in HRQoL and clinical outcomes, and used latent class analysis (LCA) to identify symptom-based profiles at week 13 predictive of disease course. Early worsening of bone pain [hazard ratio (HR) 1.45, p = 0.010] and sleep quality (HR 1.45, p = 0.007) were associated with increased risk of mortality. LCA identified three distinct patient profiles at week 13; those in the limited symptoms class were more likely to have received CaboNivo and to have a longer treatment duration, and were generally less likely to experience disease progression than patients in other symptom classes. This analysis demonstrated a link between early changes in patient-reported outcomes and efficacy in the CheckMate 9ER study, highlighting the importance of balancing efficacy, tolerability, and HRQoL to optimize treatment outcomes and support shared decision-making.Trial Registration NCT03141177.