LITESPARK-012: adding belzutifan or quavonlimab to pembrolizumab plus lenvatinib does not improve first-line RCC outcomes

Phase 3 RCT · OncoDaily · 2026-10-25. Number 1 in the UrologyWatch Top 5 for November 2, 2026.

In first-line advanced RCC, neither pembrolizumab plus lenvatinib plus belzutifan nor MK-1308A (quavonlimab plus pembrolizumab) plus lenvatinib beat pembrolizumab plus lenvatinib. Median PFS was 20.8 and 20.7 vs 23.7 months (HR 1.08 and 1.07), and OS HRs were 1.04 and 1.12. ORR was 69.1% and 69.0% vs 76.3%.

Why it matters: Pembrolizumab plus lenvatinib remains a first-line standard; adding a HIF-2 alpha inhibitor or a CTLA-4 antibody did not help.

Limitation: Results from a meeting presentation; full publication pending.

Source: OncoDaily

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