LITESPARK-005
Trial question
What is the role of belzutifan in patients with advanced renal cell carcinoma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 746
746 patients (165 female, 581 male)
Inclusion criteria: patients with advanced clear-cell renal cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies
Key exclusion criteria: previous everolimus therapy; additional malignancy that is progressing or has required active treatment within the past 3 years; CNS metastases and/or carcinomatous meningitis; clinically significant cardiac disease
Interventions
N=374 belzutifan (at an oral dose of 120 mg daily)
N=372 everolimus (at an oral dose of 10 mg daily)
Primary outcome
Progression-free survival at 18 months
24
8.3
24.0 %
18.0 %
12.0 %
6.0 %
0.0 %
Belzutifan
Everolimus
Significant
increase ▲
NNT = 6
Significant increase in progression-free survival at 18 months (24% vs. 8.3%; HR 1.33, 95% CI 1.11 to 1.59)
Secondary outcomes
No significant difference in median overall survival (21.4 months vs. 18.1 months; HR 1.14, 95% CI 0.93 to 1.37)
Significant increase in objective response rate (21.9% vs. 3.5%; AD 18.4%, 95% CI 14 to 23.2)
Safety outcomes
No significant difference in adverse events and treatment-related adverse events.
Conclusion
In patients with advanced clear-cell renal cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies, belzutifan was superior to everolimus with respect to a progression-free survival at 18 months.
Reference
Toni K Choueiri, Thomas Powles, Katriina Peltola et al. Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma. N Engl J Med. 2024 Aug 22;391(8):710-721.
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