Belzutifan-lenvatinib keeps PFS and response edge over cabozantinib in RCC, OS not significant

Phase 3 RCT · Ann Oncol · 2026-10-26. Number 4 in the UrologyWatch Top 5 for October 26, 2026.

Final LITESPARK-011 analysis in previously treated advanced clear-cell RCC shows belzutifan plus lenvatinib maintained PFS (HR 0.74) and response rate benefits over cabozantinib, but mature OS (HR 0.85) did not cross the prespecified significance boundary.

Why it matters: Supports belzutifan-lenvatinib as an option after anti-PD-(L)1 therapy for PFS and response, though OS benefit remains unproven.

Limitation: OS analysis did not meet the prespecified statistical boundary despite a numerical difference favoring the combination.

Source: Ann Oncol · PubMed 42927855 · DOI 10.1016/j.annonc.2026.10.109

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