In a health-related quality-of-life (QOL) analysis reported in The Lancet Oncology, Powles et al found that belzutifan had better QOL on patient-reported outcomes vs everolimus in patients with advanced renal cell carcinoma in the phase III LITESPARK-005 trial.
Study Details
Belzutifan is approved for patients with advanced renal cell carcinoma previously treated with immune checkpoint and antiangiogenic therapy based on findings in LITESPARK-005. In the open-label trial, 746 patients from 12 countries/regions were randomly assigned between March 2020 and January 2022 to receive belzutifan at 120 mg once daily (n = 374) or everolimus at 10 mg once daily (n = 372).
Patient-reported outcomes from LITESPARK-005 were assessed using Functional Assessment of Cancer Therapy–Kidney Cancer Symptom Index: Disease Related Symptoms (FKSI-DRS) and the EORTC QOL Questionnaire Core 30 (EORTC QLQ-C30).
Key Findings
For belzutifan vs everolimus, the change from baseline to week 17 in FKSI-DRS score (difference in least-squares mean between groups = 1.5 [95% confidence interval (CI) = 0.7–2.2]) and in QLQ-C30 global health status QOL score (difference in least-squares mean = 6.4 (95% CI = 3.2–9.6) indicated stability on these measures with belzutifan vs worsening with everolimus.
Change from baseline to week 17 was similar between groups for QLQ-C30 physical functioning (difference in least-squares mean = 2.5, 95% CI = −0.6 to 5.5) and QLQ-C30 role functioning (difference in least-squares mean = 4.2, 95% CI = 0.1–8.4) subscale scores.
The time to deterioration in EORTC physical function was not significantly different in the belzutifan group vs the everolimus group (median = 19.3 months vs 13.8 months, hazard ratio [HR] = 0.93, 95% CI = 0.72–1.20), and no difference in the time to deterioration of role function was observed between the two groups (median = 12.0 vs 10.2 months; HR = 0.88, 0.69–1.11).
The investigators concluded: “Belzutifan for advanced renal cell carcinoma was associated with improved disease-specific symptoms and QOL compared with everolimus. Taken together with the efficacy and safety data from LITESPARK-005, belzutifan could offer a clinical benefit without compromising the QOL of patients in this setting.”
Thomas Powles, MD, of Barts Cancer Institute, Queen Mary University of London, is the corresponding author of The Lancet Oncology article.
Disclosure: The study was funded by Merck Sharp & Dohme, a subsidiary of Merck & Co. For full disclosures of the study authors, visit thelancet.com.
