Kura Reports Durable Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve ccRCC at KCRS 2026

Kura Oncology presented updated Phase 1a results from the FIT-001 trial (NCT06026410) at KCRS 2026, showing durable clinical activity of darlifarnib plus cabozantinib in cabozantinib-naïve clear cell RCC patients, with ORR up to 50%, median PFS of 13 months, and a safety profile consistent with the known profiles of the individual agents, supporting continued development in later-line ccRCC and upcoming randomized Phase 1b enrollment in the US and EU to select a recommended Phase 3 dose.

The combination demonstrated robust antitumor activity in heavily pretreated, cabozantinib-naïve patients, exceeding historical benchmarks for TKI and HIF‑2α monotherapies, with durable benefit and more than half of patients remaining on treatment at data cut‑off, and Kura plans a registrational Phase 3 study in 2028.

Analysis of cabozantinib‑exposed ccRCC patients (n=16) showed an ORR of 44% and disease control rate of 94%, underscoring potential to overcome or delay resistance to VEGFR‑targeted therapies, with manageable toxicity primarily managed by dose interruption or reduction.