LITESPARK-011 final analysis: belzutifan plus lenvatinib keeps its PFS edge over cabozantinib, but OS is not significant
Phase 3 RCT · OncoDaily · 2026-10-26. Number 2 in the UrologyWatch Top 5 for November 2, 2026.
In 747 patients with advanced RCC after anti-PD-(L)1 therapy (median follow-up 38.8 months), belzutifan plus lenvatinib versus cabozantinib gave median PFS of 14.8 vs 10.8 months (HR 0.74) and ORR of 53.1% vs 40.2%. Median OS was 33.7 vs 28.6 months (HR 0.85, 95% CI 0.70 to 1.03), which did not cross the prespecified significance boundary. Grade 3 or higher adverse events were 85.4% vs 83.0%.
Why it matters: Supports belzutifan plus lenvatinib as a post-immunotherapy option on PFS and response, without a proven overall survival gain.
Limitation: Open-label trial; OS endpoint not met.
Source: OncoDaily
Loading today's edition…