MedPath

Belzutifan Yields Sustained Responses, PFS in Advanced Clear Cell RCC - Cancer Network

Final analysis of LITESPARK-005 showed belzutifan maintained PFS and ORR benefits over everolimus in advanced clear cell RCC, with durable responses lasting over 2 years, though no OS improvement. Belzutifan, an oral HIF-2a inhibitor, led to a higher ORR (22.7%) vs everolimus (3.5%) and longer median DOR (19.3 months vs 13.7 months). Despite longer treatment duration, belzutifan exhibited comparable or reduced toxicities. No new safety signals were observed.


Reference News

Belzutifan Yields Sustained Responses, PFS in Advanced Clear Cell RCC - Cancer Network

Final analysis of LITESPARK-005 showed belzutifan maintained PFS and ORR benefits over everolimus in advanced clear cell RCC, with durable responses lasting over 2 years, though no OS improvement. Belzutifan, an oral HIF-2a inhibitor, led to a higher ORR (22.7%) vs everolimus (3.5%) and longer median DOR (19.3 months vs 13.7 months). Despite longer treatment duration, belzutifan exhibited comparable or reduced toxicities. No new safety signals were observed.

Belzutifan Has Durable PFS, ORR in Previously Treated Advanced Clear Cell RCC

Belzutifan showed improved PFS and ORR vs everolimus in advanced clear cell RCC but did not outperform in OS, according to the phase 3 LITESPARK-005 trial. Median PFS was 5.6 months for both drugs, with belzutifan achieving higher 12- and 24-month PFS rates. Median OS was 21.4 months with belzutifan vs 18.2 months with everolimus, with no significant difference. Belzutifan led to a higher ORR of 22.7% vs 3.5% with everolimus, and more patients remained on belzutifan treatment. No new safety signals were observed, with comparable or reduced toxicities.

© Copyright 2025. All Rights Reserved by MedPath