34 Belzutifan Plus Lenvatinib Versus Cabozantinib in Post–PD-(L)1 Renal Cell Carcinoma: Health-Related Quality-of-Life Outcomes in the Phase 3 LITESPARK-011 Study

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Abstract Background Belzutifan plus lenvatinib significantly improved progression-free survival and objective response rate versus cabozantinib, and had manageable safety, in participants with advanced renal cell carcinoma (RCC) that progressed on or after anti-programmed cell death protein 1 and anti-programmed cell death ligand 1 (anti–PD-[L]1) therapy in the phase 3 LITESPARK-011 study (NCT04586231). We report health-related quality of life (HRQoL) outcomes from LITESPARK-011. Methods Participants ≥18 years of age with advanced RCC that progressed on or after anti–PD-(L)1 therapy as the immediate prior treatment were randomly assigned 1:1 to receive belzutifan 120 mg plus lenvatinib 20 mg by mouth once daily or cabozantinib 60 mg by mouth once daily. HRQoL was evaluated in participants who received ≥1 dose of study treatment and completed ≥1 patient-reported outcome (PRO). Prespecified exploratory end points included time to deterioration (TTD) and least squares mean (LSM) change from baseline in Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index-Disease Related Symptoms (FKSI-DRS), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status/quality of life (GHS/QoL), physical functioning, and role functioning subscales. Questionnaires were completed electronically on day 1 of week 1, 3, 5, and 9, every 4 weeks thereafter, at treatment discontinuation, and 30 days after last dose. The analysis timepoint was week 45 (last timepoint where completion and compliance rates of ∼60% and ≥80%, respectively, were observed). PROs were not formally statistically tested. Results The PRO analysis population included 731 participants (n = 365, belzutifan plus lenvatinib; n = 366, cabozantinib). At data cutoff (Apr 9, 2025), median study follow-up was 29.0 months (range, 19.3-49.2). Completion rates for FKSI-DRS and QLQ-C30 were >85% at baseline (compliance >86%) and >55% at week 45 (compliance >89%) in each arm. TTD and LSM change from baseline in FKSI-DRS, QLQ-C30 GHS/QoL, physical functioning, and role functioning scores were similar between arms (Table). Conclusions Belzutifan plus lenvatinib had similar TTD for FKSI-DRS, and GHS/QoL, physical functioning, and role functioning versus cabozantinib. LSM changes in HRQoL and disease-specific symptoms from baseline to week 45 were also similar for both arms. Combined with efficacy and safety data, results support belzutifan plus lenvatinib as a new treatment option for advanced RCC that progressed after anti–PD-(L)1 therapy. 2026 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2026 ASCO Annual Meeting. All rights reserved.

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