Dr Ayanambakkam on Efficacy Outcomes With Darlifarnib Plus Cabozantinib in ccRCC

“Our objective response rate was 44% even in this heavily patient population that had [prior] cabazantinib.”

Adanma Ayanambakkam, MD, MS, the associate program director of hematology oncology fellowship and the director of infusion services at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, discussed efficacy data with darlifarnib (KO-2806) in combination with cabozantinib (Cabometyx) in patients with clear cell renal cell carcinoma (ccRCC).

Findings from the phase 1a/1b FIT-001 trial (NCT06026410), a first-in-human study evaluating darlifarnib alone and in combination with cabozantinib in adult patients with advanced solid tumors were presented during the 2026 International Kidney Cancer Symposium: Europe. In this study, patients with ccRCC who received prior cabozantinib (n = 16) experienced an overall response rate (ORR) of 44% (95% CI, 19.8%-70.1%), Ayanambakkam said. Notably, most patients received cabozantinib at a dose of 40 mg (n = 13), he added. The disease control rate was 94% (95% CI, 69.8%-99.8%), he noted.

Importantly, 56% of patients included in the efficacy population received cabozantinib as their immediate prior line of therapy, Ayanambakkam explained. All patients experienced disease progression on cabozantinib prior to enrollment, he added.

Additional findings from FIT-001 revealed that patients with cabozantinib-exposed ccRCC who received darlifarnib at 3 mg and cabozantinib at 40 mg (n = 5) experienced an ORR of 40% (95% CI, 5.3%-85.3%) and a DCR of 100% (95% CI, 47.8%-100%). Those treated with darlifarnib at 5 mg and cabozantinib at 40 mg (n = 6) experienced an ORR and DCR of 33% (95% CI, 4.3%-77.7%) and 100% (95% CI, 54.1%-100%), respectively. The ORR and DCR were both 50% (95% CI, 1.3%-98.7%) among patients who received darlifarnib at 8 mg and cabozantinib at 40 mg (n = 2). Patients who received darlifarnib at 3 mg and cabozantinib at 60 mg (n = 3) achieved an ORR of 67% (95% CI, 9.4%-99.2%) and a DCR of 100% (95% CI, 29.2%-100%).

Disclosures: Ayanambakkam reported consulting or advisory roles with AVEO, Pfizer/Astellas, Johnson & Johnson, and Kura Oncology. He received travel, accommodations, and/or expenses from Kura Oncology and research funding from Regeneron.