Eikon Therapeutics Presents Updated EIK1001 Data from TeLuRide-005 at the European Society for Medical Oncology Congress

The combination supported outpatient administration during the ongoing trial, while treatment-related adverse events caused discontinuation in 6.9%.

Rhea-AI Summary

Eikon Therapeutics (EIKN) presented updated TeLuRide-005 results evaluating EIK1001 with pembrolizumab and chemotherapy in previously untreated stage 4 lung cancer. The open-label trial enrolled 72 participants with non-small cell lung cancer. Among 65 efficacy-evaluable participants, the objective response rate, measuring tumor shrinkage, was 63.1%; disease control was 89.2% after median follow-up of 17.2 months.

The squamous cohort had a 72% response rate, 100% disease control and median response duration of 12.9 months. The non-squamous cohort had 55.6% response and 80.6% disease control. Among 72 safety-evaluable participants, Grade 3 or higher treatment-related adverse events occurred in 48.6%, and treatment-related events caused discontinuation in 6.9%; none caused death. TeLuRide-008, a Phase 2/3 trial, is enrolling; Eikon expects its dose-selection interim analysis in second-half 2027.

8 points · 0 major

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0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPooled efficacy in 65 participants: 63.1% response and 89.2% disease control after median 17.2-month follow-up.
• Moderate point. Forward-looking: it has not happened yet and may not happen.TeLuRide-008 Phase 2/3 trial is actively enrolling; Eikon expects a dose-selection interim analysis in second-half 2027.
• Minor pointSquamous cohort: 72% response, 100% disease control and 12.9-month median response duration after median 12.7-month follow-up.
• Minor pointNon-squamous cohort: 55.6% response, 80.6% disease control and 11.2-month median response duration after median 17.9-month follow-up.
• Minor pointObjective responses occurred across all PD-L1 tumor proportion score subgroups.

3 minor points

• Minor pointCytokine release syndrome was limited to five Grade 1 and two Grade 2 events; none were Grade 3 or higher.
• Minor pointTreatment-related adverse events caused no deaths among 72 safety-evaluable participants.
• Minor pointThe combination's tolerability supported outpatient administration during the ongoing trial.

Negative

• Moderate pointGrade 3 or higher treatment-related adverse events affected 48.6% of 72 safety-evaluable participants.
• Minor pointTreatment-related adverse events caused treatment discontinuation in 6.9% of participants.
• Minor pointGrade 3 or higher treatment-related neutropenia affected 30.6%, anemia 9.7% and thrombocytopenia 9.7%.

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Key Figures

Pooled objective response rate: 63.1% Pooled disease control rate: 89.2% Squamous objective response rate: 72.4% +4 more

Pooled objective response rate

63.1%

TeLuRide-005; median follow-up of 17.2 months

Pooled disease control rate

89.2%

TeLuRide-005; median follow-up of 17.2 months

Squamous objective response rate

72.4%

TeLuRide-005 squamous cohort

Squamous disease control rate

100%

TeLuRide-005 squamous cohort

Squamous median duration of response

12.9 months

TeLuRide-005 squamous cohort

Grade 3 or higher treatment-related adverse events

48.6%

TeLuRide-005 safety-evaluable population

Treatment-related adverse events leading to discontinuation

6.9%

TeLuRide-005 safety-evaluable population

Key Terms

tlr7/8 dual-agonist, nsclc, objective response rate (orr), disease control rate (dcr), +1 more

5 terms

tlr7/8 dual-agonist medical

"TLR7/8 dual-agonist EIK1001"

A tlr7/8 dual-agonist is a drug or molecule that binds to and activates both Toll‑like receptor 7 (TLR7) and Toll‑like receptor 8 (TLR8), which are immune-system sensors that detect certain RNA patterns. Activating these receptors triggers innate immune signaling in cells such as dendritic cells and macrophages, causing production of interferons and other cytokines; because that response can be strong, dual‑agonists are used to boost immune activity (for example as vaccine adjuvants or in cancer and antiviral therapies) and require careful dosing or targeted delivery to limit systemic inflammation.

nsclc medical

"participants with advanced NSCLC"

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

objective response rate (orr) medical

"objective response rate (ORR) and 89.2% disease control rate"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors shrink by a pre-set amount for a minimum time, counting both complete disappearance and meaningful partial shrinkage. Investors watch ORR because it gives an early, quantitative signal that a treatment is having a direct effect on disease—like the percent of people whose fever drops after taking a medicine—which can influence expectations for later trial success, regulatory approval, and market potential.

disease control rate (dcr) medical

"63.1% objective response rate (ORR) and 89.2% disease control rate (DCR)"

The disease control rate (DCR) is the share of patients in a clinical trial whose cancer either shrinks, disappears, or does not get worse for a predefined period after treatment. For investors, DCR is a practical measure of a drug’s ability to halt disease progression — akin to counting how many cars in a fleet are kept running or fixed after a repair — and can influence a therapy’s regulatory prospects, market potential, and perceived risk.

treatment-related adverse events (traes) medical

"Grade 3 or higher treatment-related adverse events (TRAEs)"

Treatment-related adverse events (TRAEs) are unwanted symptoms or medical problems that patients experience and clinicians determine are likely caused by a drug, device, or medical procedure. Investors care because TRAEs influence a treatment’s safety profile, regulatory approval, labeling, market acceptance and potential legal or cost implications—similar to customer complaints for a product that can limit sales, trigger warnings or require fixes.

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• TLR7/8 dual-agonist EIK1001 plus pembrolizumab and chemotherapy in first-line, stage 4 non-small cell lung cancer (NSCLC) demonstrates durable effect in combination with standard-of-care, and a tolerability profile supportive of systemic administration in an outpatient setting
• With median follow-up of 12.7 months, objective response rate (ORR) for the squamous cohort was 72% and disease control rate (DCR) was 100%, with a median duration of response of 12.9 months and multiple participants continuing in active follow-up
• TeLuRide-008, an ongoing adaptive Phase 2/3 trial of EIK1001 in NSCLC, actively enrolling, with a prespecified interim analysis for dose selection anticipated in 2H 2027
  

MILLBRAE, Calif., Oct. 26, 2026 (GLOBE NEWSWIRE) -- Eikon Therapeutics, Inc. (Nasdaq: EIKN) (“Eikon”), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, today announced the presentation of updated data for EIK1001 at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain.

“These updated results presented at ESMO from the squamous NSCLC cohort build on the mature non-squamous cohort data presented at ASCO and further support the potential of adding EIK1001 to pembrolizumab and chemotherapy,” said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon. “The observed response and disease control rates, as well as a 12.9-month median duration of response, are encouraging, with several patients remaining in active follow-up. These findings support continued evaluation of this combination for patients with advanced NSCLC.”

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.

About Eikon Therapeutics
Eikon is a late-stage clinical biopharmaceutical company dedicated to building a global, fully integrated organization developing innovative medicines to address serious unmet medical needs. Eikon’s initial focus is oncology, where it is advancing a pipeline of drug candidates targeting areas of high unmet need that could eventually become critical medicines for the treatment of various cancers. Eikon deploys its technology platform, including its proprietary single molecule tracking system, to develop internally derived novel therapies, while also leveraging the deep expertise of its management team to in-license promising assets. Eikon’s vision is to become a generational leader by purposefully integrating traditional biology research with advanced engineering to develop better medicines faster. For more information, visit www.eikontx.com.

About NSCLC
Lung cancer is one of the most common cancers globally, with NSCLC making up 80% to 85% of all lung cancer cases. NSCLC is often diagnosed at advanced stages when treatment options are more limited and there remains significant unmet medical need in this patient population. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The current standard of care for stage 4 NSCLC, combining immune checkpoint inhibitors (ICIs) (e.g., pembrolizumab) plus histology-appropriate chemotherapy confers significant clinical benefit over chemotherapy alone, yet many patients progress nonetheless, highlighting the large unmet medical need in the management of this disease.

About EIK1001
EIK1001 is an investigational, systemically administered dual-agonist of Toll-like receptors 7 and 8, designed to stimulate both innate and adaptive immune responses. In Phase 1 trials of EIK1001, single-agent activity was observed in patients with advanced malignancy. This mechanism may complement the anti-tumor immune response engendered by PD-(L)1 blockade. EIK1001 has been studied in over 600 participants and observed to be well-tolerated to date, both as a monotherapy and in combination with PD-(L)1-specific antibody-based therapy.

About TeLuRide-005
TeLuRide-005 (NCT06246110) is a multicenter, open-label trial of once-weekly (QW) systemically administered EIK1001 in combination with standard of care, once every third week (Q3W) pembrolizumab and histology-appropriate chemotherapy in first-line, treatment-naïve participants with stage 4 NSCLC. Enrollment completed in the first quarter of 2026.

Forward-Looking/Safe Harbor Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical facts are hereby identified as forward-looking statements for this purpose. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the therapeutic potential, safety, and efficacy of Eikon’s product candidates; the potential to further develop Eikon’s product candidates; the timing for anticipated data readouts; expected milestones and business objectives, including Eikon’s anticipated presentations at the 2026 ESMO Congress; and other statements regarding Eikon’s future operations, financial performance, financial position, prospects, objectives, strategies and other future events.

These forward-looking statements are based upon management’s current expectations and assumptions, and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: our limited operating history; our significant net losses incurred since inception and the likelihood of incurring additional losses for the foreseeable future; our need for substantial additional funding; the early stage of development of many of our product candidates and the possibility that our product candidates may fail in development; our dependence on the success of our current product candidates; our ability to leverage our technology platform to enable more informed drug research and development; legal and regulatory risks; intellectual property-related risks; and those risks, uncertainties and other factors discussed under the caption “Risk Factors” and elsewhere in Eikon’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission (“SEC”) on August 13, 2026, and in other public filings with the SEC in the future.

As a result, you should not place undue reliance on any forward-looking statements. The forward-looking statements made in this press release speak only as of the date of this press release, and Eikon undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law.

Contacts:

Investors
Alfred “Freddie” Bowie, Ph.D., CFO
ir@eikontx.com

Media
Colin Sanford
colin@bioscribe.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Eikon's EIK1001 TeLuRide-005 lung cancer trial show?

EIK1001 combined with pembrolizumab and chemotherapy produced a 63.1% objective response rate and 89.2% disease control rate among 65 efficacy-evaluable participants. Median follow-up was 17.2 months at the October 1, 2026 efficacy cutoff. The trial evaluated previously untreated stage 4 non-small cell lung cancer.

When does Eikon expect the EIK1001 TeLuRide-008 interim analysis?

Eikon expects the first interim analysis in the second half of 2027 to select a single EIK1001 dose for the remainder of TeLuRide-008. The Phase 2/3 trial is actively enrolling participants with previously untreated stage 4 squamous or non-squamous non-small cell lung cancer.

How was EIK1001 administered in Eikon's TeLuRide-005 trial?

Participants received intravenous EIK1001 once weekly, reduced to once every third week after 8 cycles. Pembrolizumab and chemotherapy were administered once every third week. Maximum treatment duration for EIK1001 with pembrolizumab is 2 years, up to 35 cycles; pemetrexed may continue at the investigator's discretion for non-squamous participants.