Eikon Therapeutics, Inc. announced updated data from its TeLuRide-005 clinical trial of EIK1001 at the 2026 European Society for Medical Oncology (ESMO) Congress on October 26, 2026. The trial evaluates EIK1001, a TLR7/8 dual-agonist, in combination with pembrolizumab and histology-appropriate chemotherapy for participants with advanced non-small cell lung cancer (NSCLC).
The open-label study enrolled 72 participants with previously untreated stage 4 NSCLC. Treatment involved intravenous EIK1001 administered once weekly for the first eight cycles, followed by once every third week, combined with standard-of-care pembrolizumab and chemotherapy.
Regarding safety, the combination was generally well tolerated with an adverse event profile similar to standard care alone. At the July 13, 2026, safety data cutoff, 48.6% of participants experienced Grade 3 or higher treatment-related adverse events (TRAEs), with neutropenia being the most common (30.6%). Notably, cytokine release syndrome events were all low-grade, and no Grade 3 or higher events occurred. This profile supported administration in an outpatient setting.
Efficacy data, evaluated at an October 1, 2026, cutoff, showed an objective response rate (ORR) of 63.1% and a disease control rate (DCR) of 89.2% across the pooled population. In the squamous cohort, the ORR was 72.4% and the DCR was 100%, with a median duration of response of 12.9 months. In the non-squamous cohort, the ORR was 55.6% and the DCR was 80.6%, with a median duration of response of 11.2 months.
Separately, the company is conducting a Phase 2/3 registrational trial, TeLuRide-008 (NCT07365319), and expects to conduct a first interim analysis in the second half of 2027 to select the single dose of EIK1001 for the remainder of the study.
