Kura Oncology, Inc. (KURA), a biopharmaceutical company focused on precision medicine for cancer treatment, announced on Tuesday that its lead investigational farnesyl transferase inhibitor (FTI), Darlifarnib, in combination with Adagrasib, reported positive results in heavily pre-treated patients with KRAS G12C-mutated advanced solid tumours from the FIT-001 clinical trial. Darlifarnib (KO-2806) Darlifarnib is a potent next-generation inhibitor of farnesyl transferase,specifically designed to overcome resistance to multiple targeted therapies by inhibiting RHEB farnesylation, thereby sustaining blockade of mTORC1 signalling and enhancing RAS-inhibitor anti-tumour activity. FIT-001 Trial FIT-001 Trial is a Phase 1 clinical trial evaluating the safety and efficacy of darlifarnib monotherapy and its combination with targeted therapies in advanced solid tumour patients. Patients received darlifarnib 3 mg, 5 mg, or 8 mg once daily on days 1-7 and 15-21 of each 28-day cycle, in combination with adagrasib 400 mg twice daily. Key Highlights In heavily pre-treated with prior exposure to KRAS inhibitor (KRASi) pancreatic ductal adenocarcinoma (PDAC), and non-small cell lung cancer (NSCLC), along with KRASi-naïve colorectal cancer (CRC) patients, the drug combination of darlifarnib-adagrasib demonstrated significant anti-tumour activity. Of the 26 response-evaluable patients, 77% achieved tumour shrinkage. In the 16 response-evaluable KRASi-naïve patients, 94% achieved tumour shrinkage. The objective response rate (ORR) across dose levels was 67% in PDAC, 50% in NSCLC, and 29% in KRASi-naïve CRC. In NSCLC, a partial response was confirmed, and an 84% reduction in the target lesion was observed in patients previously treated with a KRAS inhibitor. The median follow-up and range for PDAC were 6.7 (4.0-10.4) months; for NSCLC, 6.9 (3.2-11.8) months; and for CRC, 8.9 (1.2-13.2) months. The combination of drugs was well-tolerated with a manageable safety profile, according to the company. KURA has traded between $5.45 and $12.49 over the last year. The stock is currently trading at $11.31, up 0.53%
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