Kura Oncology presented data from the FIT‑001 study at the 2026 International Kidney Cancer Symposium in Paris on April 17 2026, showing that the combination of darlifarnib and cabozantinib produced robust activity in patients with clear‑cell renal cell carcinoma who had previously progressed on cabozantinib and received immunotherapy.
The study evaluated once‑daily darlifarnib at 3 mg, 5 mg, or 8 mg in a 7‑day on/off schedule together with cabozantinib at 60 mg or 40 mg once daily. Among the heavily pre‑treated cohort, the objective response rate was 44 %, the disease‑control rate 94 %, and 75 % of patients experienced tumor shrinkage, with reductions ranging from 32 % to 47 % among responders. Treatment durations ranged from 8 to 56 weeks, and six patients remained on therapy at the time of analysis.
Chief Medical Officer Mollie Leoni said, "These data highlight the potential of darlifarnib to overcome resistance to prior cabozantinib and enhance the activity of VEGF TKIs in patients with advanced RCC." She added, "We are highly encouraged by these results and are committed to advancing this combination to evaluate further its potential to deliver meaningful benefit for RCC patients." Assistant Professor Adanma Ayanambakkam noted, "Patients with advanced ccRCC whose disease progresses on cabozantinib have limited treatment options. The tumor shrinkage and high disease control rate observed with darlifarnib in combination with cabozantinib suggest this approach may offer meaningful clinical benefit in a refractory setting or in patients with disease progression after therapy."
The high objective response and disease‑control rates in a population with limited options suggest that darlifarnib could become a new therapeutic option for patients who have progressed on cabozantinib, strengthening Kura’s pipeline and potentially expanding its market share in the renal cell carcinoma space. The advancement of the study into Phase 1b dose‑expansion reflects continued investment and confidence in the combination’s potential.
Investors responded favorably to the data, with analysts citing the high ORR and DCR as key drivers of the positive market reaction. The results build on earlier encouraging data presented at the 2025 ESMO Congress, reinforcing the company’s trajectory in targeted oncology.
Kura is also developing ziftomenib, which received FDA approval for acute myeloid leukemia in late 2025, and its Q4 2025 financials showed a net loss of $81.0 million on revenue of $17.34 million. The company’s focus on targeted therapies positions it to capitalize on unmet needs in oncology.
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