LITESPARK-022
Adding the HIF-2α pill to a year of adjuvant pembrolizumab further reduced recurrence, and became the first adjuvant combination approved in kidney cancer.
First interim analysis presented at ASCO GU 2026 showed a statistically significant DFS improvement over pembrolizumab alone; OS immature. FDA approval Q2 2026 of belzutifan + pembrolizumab as adjuvant therapy. Raises the question of benefit versus harm in patients who would never have relapsed.
Setting
Clear-cell RCC at high risk after nephrectomy: adjuvant pembrolizumab + belzutifan vs pembrolizumab + placebo
Phase
Phase 3
Sponsor
Merck
Registry
Headline result
DFS significantly improved vs pembrolizumab (interim; HR presented ASCO GU 2026).
Reported
2026
Enrolled
1600
Replication
Builds on KEYNOTE-564; no independent replication yet.