Clinical TrialMay 26, 2026, 06:04 AM
Kura Oncology darlifarnib trial shows 77% tumor shrinkage, high ORRs
AI Summary
Kura Oncology reported compelling first-in-human data from its FIT-001 clinical trial of darlifarnib in combination with adagrasib for KRAS G12C-mutated advanced solid tumors. The trial demonstrated 77% tumor shrinkage in response-evaluable patients, including those heavily pretreated and KRASi-experienced. Objective response rates were 67% in PDAC, 50% in NSCLC, and 29% in KRASi-naïve CRC patients, reinforcing darlifarnib's potential as a precision combination agent with a manageable safety profile. These results will be presented at the 2026 ASCO Annual Meeting, and the company will host a virtual investor event on June 3, 2026.
Key Highlights
- 77% (20/26) of response-evaluable patients achieved tumor shrinkage.
- 94% (15/16) of response-evaluable, KRASi-naïve patients achieved tumor shrinkage.
- Objective response rate (ORR) was 67% in PDAC patients.
- ORR was 50% in NSCLC patients.
- ORR was 29% in KRASi-naïve CRC patients.
- 37% of patients remained on study treatment at data cutoff (March 25, 2026).
- Kura Oncology will host a virtual investor event on June 3, 2026.
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