A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
Summary
The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.
Timeline
- Start
- 2020-02-27
- Primary completion
- 2024-04-15
- Completion
- 2026-09-17
Outcome
Mixed primary results
registry analysis (superiority test); Belzutifan vs Everolimus; p = 0.00031; Hazard Ratio (HR) 0.74 (95% CI 0.63 to 0.88); Log Rank NCT04195750 ↗
registry analysis (superiority test); Belzutifan vs Everolimus; p = 0.17644; Hazard Ratio (HR) 0.92 (95% CI 0.77 to 1.10); Log Rank NCT04195750 ↗
release “First positive Phase 3 results for WELIREG from LITESPARK-005 showed statistically significant improvements in PFS versus everolimus” merck.com ↗
release “overall survival (OS), the trial’s dual primary endpoint, favored WELIREG versus everolimus” merck.com ↗
release “however, this result did not reach statistical significance.” merck.com ↗
Publications
- Results Choueiri TK, Powles T, Peltola K, de Velasco G, Burotto M, Suarez C, Ghatalia P, Iacovelli R, Lam ET, Verzoni E, Gumus M, Stadler WM, Kollmannsberger C, Melichar B, Venugopal B, Gross-Goupil M, Poprach A, De Santis M, Schutz FA, Park SH, Nosov DA, Porta C, Lee JL, Garcia-Del-Muro X, Biscaldi E, Manneh Kopp R, Oya M, He L, Wang A, Perini RF, Vickery D, Albiges L, Rini B; LITESPARK-005 Investigators. Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma. N Engl J Med. 2024 Aug 22;391(8):710-721. doi: 10.1056/NEJMoa2313906.
- Powles T, Choueiri TK, Albiges L, Peltola K, de Velasco G, Burotto M, Suarez C, Ghatalia P, Iacovelli R, Lam ET, Verzoni E, Gumus M, Stadler WM, Kollmannsberger C, Melichar B, Venugopal B, Gross-Goupil M, Poprach A, De Santis M, Rizzo M, Shinde R, Saretsky TL, He L, Perini RF, Vickery D, Rini B. Health-related quality of life with belzutifan versus everolimus for advanced renal cell carcinoma (LITESPARK-005): patient-reported outcomes from a randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Apr;26(4):491-502. doi: 10.1016/S1470-2045(25)00032-4. Epub 2025 Mar 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belzutifan | Small molecule | 120 mg | Oral |
| Comparator | Everolimus | Small molecule | 10 mg | Oral |