Kura Oncology Reports Darlifarnib Clinical Trial Data

Kura Oncology reported compelling first-in-human data from the FIT-001 clinical trial of its next-generation farnesyl transferase inhibitor, or FTI, darlifarnib in combination with adagrasib in heavily pretreated patients with KRAS G12C-mutated advanced solid tumors. The results will be presented at the 2026 American Society of Clinical Oncology, or ASCO, Annual Meeting on May 30. The combination of darlifarnib plus adagrasib demonstrated meaningful antitumor activity in heavily pretreated pancreatic ductal adenocarcinoma, or PDAC, and non-small cell lung cancer, or NSCLC, patients with prior KRAS inhibitor, or KRASi, exposure, as well as KRASi-naive colorectal cancer, or CRC, patients. These data provide clinical proof-of-mechanism for Kura's FTI platform as a precision combination that blocks RHEB-dependent mTORC1 signaling, a key resistance pathway shared across multiple targeted therapy classes. Key Highlights in Phase 1a, N=30; 26 response evaluable, are: 77% of response-evaluable patients achieved tumor shrinkage, including 94% of response-evaluable, KRASi-naive patients; Objective response rate, or ORR,: 67% in PDAC, 50% in NSCLC, and 29% in KRASi-naive CRC; Responses were observed across dose levels and tumor types; Clinical activity observed in heavily pre-treated patients, including those with prior KRASi exposure In NSCLC, confirmed partial response and 84% target lesion reduction observed in a patient previously treated with a KRAS inhibitor; Median follow-up time: PDAC 6.7 months; NSCLC 6.9 months; CRC 8.9 months; 37% of patients remained on study treatment at time of data cutoff.; Combination was well tolerated with a manageable safety profile; Best Percent Change in Target Lesion Size: PDAC, NSCLC and CRC; Best Percent Change in Target Lesion Size: PDAC, NSCLC and CRC. The waterfall plot shows best percent change from baseline in target lesion size among response-evaluable patients. Objective responses were observed across all three tumor types and dose levels. Bars that extend below the -30% horizontal line indicate target lesion reductions meeting the RECIST threshold for response, and all PRs represent confirmed partial responses.