#ESMO26 LITESPARK-011: Final Ph 3 analysis of belzutifan + lenvatinib vs cabozantinib after prior anti–PD-(L)1 in advanced ccRCC
(n=747)
🔹 PFS benefit maintained: 14.8 vs 10.8 mo; HR 0.74
🔹 ORR: 53.1% vs 40.2%
🔹 CR: 6.7% vs 1.3%
🔹 DOR: 22.0 vs 11.9 mo

🚨 Final OS numerically favored belz+len but not stat sig:
33.7 vs 28.6 mo; HR 0.85 (95% CI 0.70–1.03)
• 36-mo OS: 48.9% vs 40.6%
🔹 Benefit maintained after prior 1L IO+TKI and IO+IO
🔹 PFS2: 28.7 vs 23.4 mo; HR 0.80

Safety consistent with known profiles:
• Anemia: 70.8% vs 27%
• Hypoxia: 15.7% vs 0%
• Diarrhea/PPES more common with cabozantinib

🔑 Durable PFS + response benefit, with a numerical but non-significant OS advantage, continues to support belzutifan + lenvatinib after anti–PD-(L)1 therapy.

@urotoday