EIK1001 Clinical Update:
Updated data from the open-label TeLuRide-005 trial evaluating TLR7/8 dual-agonist EIK1001 in combination with both pembrolizumab and histology-appropriate chemotherapy in participants with advanced NSCLC demonstrates potentially durable effect of EIK1001 in combination with standard of care, as well as a tolerability profile supportive of systemic administration in an outpatient setting, a potential key differentiator of EIK1001 from previous TLR7/8 targeted therapies.
In TeLuRide-005, 72 participants with previously untreated stage 4 NSCLC received intravenous EIK1001 once-weekly (QW) combined with standard of care pembrolizumab plus histology-appropriate chemotherapy once every third week (Q3W). After 8 cycles, EIK1001 administration was reduced to Q3W. The maximum treatment duration is 2 years (up to 35 cycles) for EIK1001 in combination with pembrolizumab, with pemetrexed continued at the discretion of the Investigator for non-squamous participants.
At the July 13, 2026, safety data cutoff, among the safety evaluable population (n=72: 39 non-squamous; 33 squamous), the combination of EIK1001 with pembrolizumab and chemotherapy was generally well tolerated, with an adverse event (AE) profile similar to standard-of-care alone. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 48.6% of participants, and TRAEs led to treatment discontinuation in 6.9%. The most common Grade 3 or higher TRAEs were neutropenia (30.6%), anemia (9.7%), and thrombocytopenia (9.7%). Cytokine release syndrome events were all low-grade (Grade 1, n=5; Grade 2, n=2), and there were no Grade 3 or higher events. There were no TRAEs that led to death. This profile was sufficient to support administration in an outpatient setting during the ongoing trial.
Among the efficacy-evaluable population (n=65: 36 non-squamous; 29 squamous), EIK1001 treatment in combination with pembrolizumab and chemotherapy pooled data with a median follow-up of 17.2 months resulted in a 63.1% objective response rate (ORR) and 89.2% disease control rate (DCR) at the efficacy data cutoff of October 1, 2026. Objective responses were observed across all PD-L1 tumor proportion score (TPS) subgroups. Among participants in the squamous cohort, an ORR of 72.4% and a DCR of 100% were observed, respectively, with a median follow-up of 12.7 months and a median duration of response (DOR) of 12.9 months at the efficacy data cutoff. Among participants in the non-squamous cohort, an ORR of 55.6% and a DCR of 80.6% were observed, respectively, with a median follow-up of 17.9 months. The median DOR in the non-squamous cohort was 11.2 months at the efficacy data cutoff.
In addition to the TeLuRide-005 data presented at ESMO, Eikon is currently conducting a Phase 2/3 registrational trial of EIK1001 in combination with pembrolizumab and histology-appropriate chemotherapy in systemic therapy-naïve participants with stage 4 non-squamous or squamous NSCLC, also known as TeLuRide-008 (NCT07365319). Eikon expects to conduct a first interim analysis to select the single dose of EIK1001 to take forward for the remainder of this trial in the second half of 2027.