Kura Oncology, Inc. (KURA), a biopharmaceutical company focused on precision medicine for cancer treatment, on Tuesday announced positive results from a phase 1 trial of its next-generation farnesyl transferase inhibitor (FTI), darlifarnib, in combination with adagrasib in heavily pre-treated patients with KRAS G12C-mutated advanced solid tumors. Darlifarnib (KO-2806)
Darlifarnib is an investigational, potent next-generation inhibitor of farnesyl transferase, an enzyme. This drug is particularly designed to manage resistance across multiple targeted therapies by inhibiting RHEB farnesylation, resulting in the sustained blockade of mTORC1 signalling and enhancing RAS-inhibitors anti-tumor activity.
FIT-001 Trial
The phase 1 trial, dubbed FIT-001, is evaluating the safety and efficacy of darlifarnib monotherapy and in combination with targeted therapies in advanced solid tumor patients.
Escalation cohorts of patients with RAS-altered advanced solid tumors with dose escalation and dose optimization cohorts evaluating darlifarnib with cabozantinib in advanced renal cell carcinoma, and with adagrasib in KRASG12C-mutant advanced pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC) patients were included in the trial.
In the phase 1 study of each 28-day cycle, patients were administered 3mg, 5mg or 8mg darlifarnib once daily, on days 1-7 and 15-21 in combination with adagrasib 400mg, twice daily.
The company noted, darlifarnib 8mg dose will not advance for further evaluation in the darlifarnib and adagrasib combination.
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-tumor activity.
Out of the 26 response-evaluable patients, including heavily pre-treated and KRASi-exposed, 77% of the patients achieved tumor shrinkage.
In the 16 response-evaluable KRASi-naïve patients, 94% of the patients achieved tumor 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 84% reduction to target lesion was observed in patients with prior treatment with a KRAS inhibitor.
With a median follow-up range for PDAC 6.7 (4.0-10.4) months; NSCLC 6.9 (3.2-11.8) months, and CRC 8.9 (1.2-13.2) months, the clinical activity of patients with KRASi exposure and combination of drugs was well tolerated with a manageable safety profile.
As of March 25, 2026, data cut-off, 37% of the patients were retained in the study treatment.
The company stated these data provide clinical proof-of-mechanism for Kura's FTI platform for a precision combination that blocks RHEB-dependent mTORC1 signalling, which is a key resistance pathway shared across multiple targeted therapies.
The company is expected to present its phase 1 FIT-001 trial results at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting held on May 30, 2026, in Chicago, Illinois.
KURA is trading at $11.09, down 1.42%.
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