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Background

In the randomized, open-label, phase III LITESPARK-005 () study, belzutifan treatment showed superior progression-free survival (PFS; primary endpoint, HR 0.75, 95% CI 0.63–0.90, P<0.001) and overall response rate (ORR; key secondary endpoint, estimated percentage-point difference 18.4, 95% CI 14.0–23.2, P<0.00001) versus everolimus in patients with advanced/metastatic clear cell renal cell carcinoma (RCC) that progressed after prior immune checkpoint and anti-angiogenic therapies. We present patient-reported outcome (PRO) findings for belzutifan versus everolimus in LITESPARK-005.

Methods

PROs were evaluated by and questionnaires in all randomized patients with ≥1 dose study treatment and ≥1 completed PROs assessment, administered electronically on day 1 of weeks 1, 3, 5, and 9, and Q4W thereafter, at treatment discontinuation, and day 30 after last dose. Time to deterioration (TTD) and least square (LS) mean change from baseline as measured by FKSI-DRS and QLQ-C30 global health status/quality of life (GHS/QoL) and physical functioning (PF) scales were prespecified as secondary endpoints. PROs were not formally statistically tested and 95% CI and P-values were nominal and descriptive.

Results

As of June 13, 2023 (data cutoff date at second prespecified interim analysis), median (range) follow-up was 25.7 months (range of 16.8–39.1 months). Median (range) duration of treatment was 7.6 months (0.1–35.8) with belzutifan versus 3.9 months (0.0–33.2) with everolimus; 84 (22.6%) versus 18 (5.0%) patients remained on treatment. A total of 366 of 374 patients randomized to belzutifan and 354 of 372 randomized to everolimus were included in the PRO analysis population. Completion rates for FKSI-DRS and QLQ-C30 were >90% at baseline and >55% at week 17 (~4 months) in each arm. Meaningfully longer TTD in FKSI-DRS and QLQ-C30 GHS/QoL scores were observed for belzutifan versus everolimus. LS mean changes in FKSI-DRS and QLQ-C30 GHS/QoL scores suggested stability from baseline to week 17 with belzutifan versus worsening with everolimus, and a potential greater worsening in PF scores with everolimus versus belzutifan.

Conclusions

Belzutifan was associated with prolonged TTD in FKSI-DRS and EORTC QLQ-C30. Score changes from baseline to week 17 also favored belzutifan over everolimus. Overall, PRO results indicate better disease-specific symptoms and quality of life among patients treated with belzutifan compared with everolimus.

Read an interview about the study here and expert commentary about it here.