Niklas Klümper, Senior Urology Consultant at the University Medical Center Bonn, shared on X:
“Important new option for advanced clear-cell RCC after PD-1 combination therapy – FDA approval on September 24
LITESPARK-011 (n=747) shows belzutifan + lenvatinib outperforming cabozantinib:
- PFS: 14.8 vs 10.7 months – HR 0.70
- Duration of response: 23.0 vs 12.3 months
The particularly striking part for me is the durability of response – almost twice as long among responders.
OS remains immature, with HR 0.85 and no significant difference at interim analysis, so longer follow-up will be important – Looking forward to the presentation of Daniel Heng at ESMO26.
This adds a new post-IO treatment option and further strengthens the role of HIF-2α inhibition in RCC.
The next question is increasingly about sequencing: which patients should receive belzutifan + lenvatinib, cabozantinib, or another VEGF-targeted strategy – and can biomarkers help us choose? ”
You can also read:
FDA Approved Belzutifan Plus Lenvatinib in Advanced ccRCC
