Eikon Reports Updated EIK1001 Data in Phase 2 NSCLC Trial

MILLBRAE, Calif. — October 26, 2026

TeLuRide-005 Evaluates Responses Across NSCLC Histologies

TeLuRide-005 enrolled 72 participants with previously untreated stage 4 NSCLC. The safety-evaluable population included 39 participants with non-squamous disease and 33 with squamous disease. Of these, 65 participants were included in the efficacy-evaluable population: 36 with non-squamous NSCLC and 29 with squamous NSCLC. Participants received intravenous EIK1001 once weekly alongside pembrolizumab and chemotherapy administered every three weeks. After eight cycles, EIK1001 administration was reduced to every three weeks. Treatment with EIK1001 in combination with pembrolizumab could continue for up to two years, or 35 cycles. For participants with non-squamous disease, pemetrexed could continue at the investigator’s discretion. At the efficacy data cutoff of October 1, 2026, the overall response findings showed activity across both major histological groups. The squamous cohort’s 72.4% ORR and 100% DCR indicated that all 29 efficacy-evaluable participants in this group had achieved a complete response, partial response or stable disease at the reported assessment, although the precise distribution among these response categories was not provided in the announcement. Median duration of response was 12.9 months, with several participants remaining in active follow-up. In the non-squamous cohort, the ORR was 55.6%, while the DCR was 80.6%. Median duration of response in this group was 11.2 months. These results suggest that responses were observed in both histological groups, but differences in follow-up duration and cohort size should be considered when interpreting the data. The company reported a median follow-up of 17.2 months for the pooled efficacy population, compared with 12.7 months for the squamous cohort and 17.9 months for the non-squamous cohort. The trial was open-label and evaluated EIK1001 as part of a combination regimen, so the contribution of EIK1001 to the observed outcomes cannot be isolated from these data alone.

Safety Profile Supports Outpatient Administration

At the safety data cutoff of July 13, 2026, the EIK1001 combination was generally well tolerated, with an adverse-event profile described by Eikon as similar to that expected with standard-of-care treatment. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 48.6% of participants, and 6.9% discontinued treatment because of TRAEs. The most common Grade 3 or higher TRAEs were neutropenia, reported in 30.6% of participants, anemia in 9.7%, and thrombocytopenia in 9.7%. These findings reflect the safety of the combination regimen and do not attribute every reported event specifically to EIK1001. Cytokine release syndrome (CRS) events were all low-grade: five participants experienced Grade 1 CRS and two experienced Grade 2 CRS. No Grade 3 or higher CRS events were reported, and no treatment-related adverse events led to death. Eikon said the observed tolerability profile supported systemic administration in an outpatient setting during the ongoing study. The company highlighted this as a potential practical distinction from some earlier TLR7/8-targeted therapies, although direct comparative evidence was not provided. EIK1001 is a systemically administered dual agonist of Toll-like receptors 7 and 8, designed to stimulate innate and adaptive immune responses. Toll-like receptors participate in immune signaling, and their activation may complement antitumor immune responses associated with PD-1 or PD-L1 checkpoint inhibition. Combining EIK1001 with pembrolizumab and chemotherapy is intended to explore whether immune stimulation can contribute to treatment activity alongside established cancer therapies. Eikon reported that EIK1001 had been studied in more than 600 participants across monotherapy and combination programs and had been generally well tolerated to date. The TeLuRide-005 results remain investigational, and additional controlled clinical data will be needed to characterize its benefit-risk profile.

Eikon Advances EIK1001 Toward Phase 2/3 Evaluation

Eikon is continuing development through TeLuRide-008, an adaptive Phase 2/3 registrational study evaluating EIK1001 with pembrolizumab and histology-appropriate chemotherapy in participants with stage 4 non-squamous or squamous NSCLC who have not received systemic therapy for their advanced disease. The trial is actively enrolling. An interim analysis to select the EIK1001 dose for the remainder of the study is anticipated in the second half of 2027. Dose selection will be an important step in determining the regimen to evaluate in the subsequent stages of the trial. The updated TeLuRide-005 data provide additional information about response rates, response durability and tolerability in a first-line advanced NSCLC population. However, the relatively small histology-specific groups, open-label design and absence of a randomized control arm limit conclusions about the incremental effect of EIK1001 beyond pembrolizumab and chemotherapy. The safety and efficacy data also use different cutoff dates: July 13, 2026, for safety and October 1, 2026, for efficacy. These distinctions are relevant when interpreting the reported outcomes. Eikon Therapeutics is a clinical-stage biopharmaceutical company focused initially on oncology and developing therapies for serious unmet medical needs. Its research approach combines biological investigation with advanced engineering technologies, including a proprietary single-molecule tracking system. The company’s ongoing EIK1001 program seeks to evaluate systemic TLR7/8 activation as part of combination treatment for advanced cancers. Further results from TeLuRide-008 will be important to assess dose selection, confirm clinical activity and better define the safety profile in a larger registrational study. Any future regulatory decisions will depend on the results of ongoing trials and the applicable review process.

Source:Eikon Therapeutic,Press release