Market reaction
Kura Oncology shares (NASDAQ:KURA) jumped 9% on Friday following the release of preliminary clinical data indicating the company's drug combination produced measurable activity in patients with clear cell renal cell carcinoma (ccRCC) who had previously been treated with cabozantinib.
Trial findings
The results came from a subset analysis of the FIT-001 study testing darlifarnib administered in combination with cabozantinib. In the cohort of interest, the analysis reported a 44% objective response rate and a 94% disease control rate. Additionally, tumor shrinkage was documented in 75% of the patients included in the subset.
The subset comprised 16 ccRCC patients who had prior exposure to cabozantinib. Reported treatment durations ranged from 8 to 56 weeks, and six patients remained on therapy at the time the data were cut off. The company noted that responses were observed even in heavily pretreated patients, including those who had achieved only stable disease on their prior cabozantinib regimen.
Presentation and safety
The findings were presented on April 17, 2026, at the 2026 International Kidney Cancer Symposium: Europe held in Paris. Kura Oncology stated that across multiple dose levels the combination demonstrated a manageable safety profile.
Study design and status
The FIT-001 study is evaluating once-daily darlifarnib at doses of 3 mg, 5 mg or 8 mg given on an alternating schedule of 7 days on and 7 days off, combined with once-daily cabozantinib at doses of 60 mg or 40 mg. An eligibility criterion for enrollment is prior receipt of immunotherapy. According to the company, the trial has advanced into a Phase 1b dose expansion.
Implications
The reported data are preliminary and come from a small, defined subset within an early-stage study. Nonetheless, the combination produced objective responses and a high disease control rate in a population previously treated with cabozantinib. The company highlights a manageable safety profile as the investigation proceeds into dose expansion.
Note: The article reports only the information disclosed by the company and presented at the conference; it does not add independent clinical interpretation beyond those disclosures.