Kura Oncology Launches Darlifarnib Combination Platform Study

Kura Oncology highlighted new clinical and translational data supporting darlifarnib as a potential foundational combination platform for KRAS-mutant cancers and other targeted therapy settings. The data, presented at the 2026 American Society of Clinical Oncology Annual Meeting, support Kura's strategy to expand its next-generation farnesyl transferase inhibitor, or FTI, through a new platform study designed to efficiently evaluate multiple combinations and identify opportunities to improve the depth and durability of responses to targeted therapies. In preclinical models, translational data demonstrated that darlifarnib inhibits RHEB farnesylation and sustains suppression of mTORC1 signaling, a pathway implicated in adaptive resistance to KRAS inhibition. Preclinical studies further showed enhanced anti-tumor activity across multiple classes of RAS inhibitors, including mutant-selective and multi-selective RAS inhibitors, as well as pan-KRAS and pan-RAS approaches, and demonstrated tumor regressions in models previously exposed to KRAS inhibitor therapy. In the ongoing FIT-001 study, darlifarnib plus adagrasib demonstrated promising anti-tumor activity in heavily pretreated patients with KRAS G12C-mutated pancreatic ductal adenocarcinoma, non-small cell lung, and colorectal cancers. Among 26 response-evaluable patients, tumor shrinkage was observed in 77% of patients overall and in 94% of KRAS inhibitor-naive patients. Confirmed objective response rates included 67% in PDAC, 50% in NSCLC, and 29% in KRAS inhibitor-naive CRC. The ASCO findings represent the third clinical validation of Kura's FTI combination strategy, following previously reported activity in renal cell carcinoma and PIK3CA-mutated head and neck cancer. Kura believes the opportunity for darlifarnib extends beyond KRAS G12C. The Company plans to initiate a platform study designed to evaluate darlifarnib across multiple targeted therapy combinations and disease settings. The first planned combination in the new study will be darlifarnib plus daraxonrasib in 2L+ KRAS-mutant PDAC, which is expected to enter Phase 1a evaluation in early 2027.