Kura Oncology combination shrinks solid tumors in 77% of trial patients

Kura Oncology (NASDAQ:KURA) reported preliminary Phase 1a data from its FIT-001 clinical trial, showing that a combination of its next-generation farnesyl transferase inhibitor darlifarnib and adagrasib induced tumor shrinkage in 77% of evaluable patients with advanced solid tumors.

The San Diego-based biopharmaceutical company announced Tuesday that the first-in-human trial evaluated the combination regimen in heavily pretreated and refractory patients harboring KRAS G12C mutations.

The data will be formally presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on May 30.

The treatment group demonstrated marked efficacy among patients who had not previously received a KRAS inhibitor (KRASi-naïve), with 94% (15 out of 16) of these individuals experiencing tumor reduction.

Segmented by tumor type, the objective response rate (ORR) stood at 67% in pancreatic ductal adenocarcinoma (PDAC) and 50% in non-small cell lung cancer (NSCLC).

In KRASi-naïve colorectal cancer (CRC) patients, the combination yielded an ORR of 29%.

Clinical activity was recorded across multiple dose cohorts, including patients who had relapsed on prior KRAS targeting mechanisms.

At the March 25, 2026 data cutoff, 37% of the total enrolled patient base remained on the study treatment, indicating favorable durability trends.

The combination was described as well-tolerated with a manageable safety profile, aligning with earlier expectations for darlifarnib’s optimized design.

Following dose-escalation evaluations, investigators confirmed that the highest tested dose of darlifarnib (8 mg) will not be advanced further in development, as lower doses achieved optimal therapeutic thresholds.

Kura Oncology has scheduled a virtual investor event for June 3, 2026, to discuss the comprehensive trial outcomes, safety metrics, and subsequent clinical development plans for the combination asset.