On June 3, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported 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 (ASCO) (Free ASCO Whitepaper) Annual Meeting, support Kura’s strategy to expand its next-generation farnesyl transferase inhibitor (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.
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"Today’s data release and strategic update reinforce our belief that darlifarnib represents much more than a single combination opportunity," said Troy E. Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With FTI clinical proof-of-concept now demonstrated in three distinct targeted therapy settings, and translational data supporting applicability across the evolving RAS inhibitor landscape, we believe darlifarnib has the potential to become a foundational combination backbone for molecularly defined cancers. Our planned platform study is designed to accelerate development across multiple combinations and disease settings, beginning with darlifarnib plus daraxonrasib in KRAS-mutant pancreatic cancer."
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(ON) inhibitors, as well as pan-KRAS and pan-RAS approaches, and demonstrated tumor regressions in models previously exposed to KRAS inhibitor therapy.
FIT-001 ASCO (Free ASCO Whitepaper) Update
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 (PDAC), non-small cell lung (NSCLC), and colorectal (CRC) cancers. Among 26 response-evaluable patients, tumor shrinkage was observed in 77% of patients overall and in 94% of KRAS inhibitor-naïve patients. Confirmed objective response rates included 67% in PDAC, 50% in NSCLC, and 29% in KRAS inhibitor-naïve CRC. Clinical activity was also observed in patients previously treated with KRAS inhibitors.
Observed response rates compared favorably with historical adagrasib monotherapy benchmarks, supporting the hypothesis that darlifarnib may enhance the depth and durability of response when combined with KRAS-targeted therapies.
The ASCO (Free ASCO Whitepaper) 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.
Planned Platform Study
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 flexible design is intended to allow combinations with both approved and investigational targeted therapies, add new arms over time, and advance successful combinations into dedicated registrational studies.
Given the emerging clinical and translational data, Kura has seen growing interest in exploring darlifarnib across a variety of targeted therapy settings. The Company’s planned platform study is designed to provide a flexible framework that could support evaluation of additional combination opportunities over time. 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.
"The KRAS treatment landscape is evolving rapidly, with multiple next-generation mutant-selective and pan-RAS approaches advancing through clinical development," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Our data suggest darlifarnib may have broad applicability across this expanding class of therapies, creating the opportunity to improve outcomes for patients while establishing a flexible platform for future development and collaboration."
Virtual Investor Event
Kura will host a webcast and conference call on June 3, 2026, at 12:15 p.m. PT / 3:15 p.m. ET featuring management and David S. Hong, M.D., Deputy Chair of the Department of Investigational Cancer Therapeutics, The University of Texas M.D. Anderson Cancer Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.
(Press release, Kura Oncology, JUN 3, 2026, View Source [SID1234666408])