Eikon Therapeutics, Inc. presented updated results for its experimental drug EIK1001 at the 2026 European Society for Medical Oncology Congress in Madrid, Spain. The data from the TeLuRide-005 trial suggests the TLR7/8 dual-agonist can be combined with standard-of-care pembrolizumab and chemotherapy for stage 4 non-small cell lung cancer, raising questions about its potential to extend treatment duration in an outpatient setting.
Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon, stated that the updated squamous cohort results build on prior non-squamous data presented at ASCO. He noted that the observed response and disease control rates, alongside a 12.9-month median duration of response, are encouraging and support continued evaluation for patients with advanced non-small cell lung cancer.
In the TeLuRide-005 open-label trial, 72 participants with previously untreated stage 4 non-small cell lung cancer received intravenous EIK1001 once-weekly, combined with pembrolizumab and histology-appropriate chemotherapy every three weeks. After eight cycles, EIK1001 administration was reduced to every three weeks. The maximum treatment duration is two years, or up to 35 cycles.
Efficacy data from an evaluable population of 65 participants, with a pooled median follow-up of 17.2 months, showed a 63.1% objective response rate and an 89.2% disease control rate at the October 1, 2026, data cutoff. Responses were observed across all PD-L1 tumor proportion score subgroups.
Specifically, the squamous cohort of 29 participants demonstrated a 72.4% objective response rate and a 100% disease control rate. With a median follow-up of 12.7 months, the median duration of response for this group was 12.9 months. The non-squamous cohort of 36 participants showed a 55.6% objective response rate and an 80.6% disease control rate, with a median duration of response of 11.2 months at a median follow-up of 17.9 months.
Safety data from a cutoff on July 13, 2026, indicated the combination was generally well tolerated in the safety-evaluable population of 72 participants. Grade 3 or higher treatment-related adverse events occurred in 48.6% of participants, leading to treatment discontinuation in 6.9%. The most common severe treatment-related adverse events were neutropenia at 30.6%, anemia at 9.7%, and thrombocytopenia at 9.7%. Cytokine release syndrome events were all low-grade, with no Grade 3 or higher events or deaths attributed to treatment-related adverse events.
Eikon is currently conducting TeLuRide-008, an adaptive Phase 2/3 registrational trial of EIK1001 in combination with pembrolizumab and chemotherapy in therapy-naive participants with stage 4 non-small cell lung cancer. The company expects to conduct a first interim analysis to select a single dose for the remainder of the trial in the second half of 2027.