Kura Oncology (NASDAQ: KURA) shares rose 9% after investigators unveiled preliminary data from the FIT-001 trial. The study evaluates darlifarnib combined with cabozantinib in patients with cabozantinib-refractory clear cell renal cell carcinoma (ccRCC), demonstrating notable tumor shrinkage.
Impressive Response Rates in Refractory Patients
Analysis of 16 ccRCC patients previously treated with cabozantinib revealed a 44% objective response rate and 94% disease control rate. Tumor reduction occurred in 75% of cases. Treatment durations ranged from eight weeks to 56 weeks, with six patients continuing therapy at the data cutoff.
These responses particularly involved patients who had shown stable disease on prior cabozantinib, highlighting darlifarnib’s potential to overcome resistance mechanisms.
Presentation at Key Symposium
Investigators presented the findings on April 17, 2026, at the International Kidney Cancer Symposium: Europe in Paris. The company emphasized a safety profile suitable for prolonged administration.
Study Design and Patient Criteria
The phase 1b expansion portion of FIT-001 administers darlifarnib at doses of 3 mg, 5 mg, or 8 mg once daily on a seven-days-on/seven-days-off schedule, alongside cabozantinib at 60 mg or 40 mg once daily. Enrolled patients required prior immunotherapy exposure.
