Kura Oncology (NASDAQ: KURA) has reported compelling first-in-human data from the FIT-001 clinical trial of its next-generation farnesyl transferase inhibitor (FTI) darlifarnib in combination with adagrasib in heavily pretreated patients with KRAS G12C-mutated advanced solid tumors.
According to Kura, the combination of darlifarnib plus adagrasib demonstrated meaningful antitumor activity in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) patients with prior KRAS inhibitor (KRASi) exposure, as well as KRASi-naïve colorectal cancer (CRC) patients. The results will be presented at the 2026 American Society of Clinical Oncology Annual Meeting on May 30, 2026.
In a statement, Troy Wilson, PhD, JD, president and CEO of Kura, commented, “These results are very encouraging for patients and represent a major milestone for the FTI field. Darlifarnib delivered robust tumor shrinkage and high objective response rates across KRAS G12C-mutated PDAC, NSCLC and CRC. These data compare favorably to adagrasib monotherapy benchmarks and demonstrate consistent, meaningful clinical activity in three difficult-to-treat tumor types. This marks “three-for-three” for targeting the mTORC1-RHEB pathway using an FTI approach to overcome resistance to targeted therapies, building on prior positive combinations with VEGFR tyrosine kinase inhibitors and PI3Kα inhibitors, and now KRAS inhibitors. With compelling clinical activity across multiple tumor types and a manageable safety profile, darlifarnib is well-positioned as a preferred combination partner for KRAS inhibitors and other precision therapies.”
