Eikon Therapeutics启动EIK1001非小细胞肺癌注册性2/3期试验首例给药

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MILLBRAE, Calif. - Eikon Therapeutics Inc. (NASDAQ:EIKN) announced today that the first patient has been dosed in TeLuRide-008, a Phase 2/3 study evaluating EIK1001 in combination with pembrolizumab and chemotherapy for treatment-naïve patients with stage 4 Non-Small Cell Lung Cancer.
The global, multicenter, double-blind, placebo-controlled study will evaluate EIK1001 administered intravenously in combination with pembrolizumab and histology-appropriate chemotherapy for systemic therapy-naïve participants with stage 4 non-squamous or squamous NSCLC, according to a press release statement. The study will be conducted in two phases and analyzed in three parts: dose optimization, dose expansion and confirmatory hypothesis testing.
For non-squamous histology, the specific chemotherapy is pemetrexed plus either carboplatin or cisplatin. For squamous histology, it is carboplatin plus paclitaxel or nab-paclitaxel.
TeLuRide-008 is the second registrational Phase 2/3 trial for EIK1001. The company initiated TeLuRide-006, which is enrolling patients with advanced malignant melanoma, in May 2025.
EIK1001 is an investigational, systemically administered dual-agonist of Toll-like receptors 7 and 8. The drug candidate has been studied in over 500 patients and has been observed to be well-tolerated as a monotherapy and in combination with PD-(L)1-specific antibody-based therapy, the company stated.
Lung cancer is one of the most common cancers globally, with NSCLC accounting for 80 to 85 percent of all lung cancer cases. The disease is often diagnosed at advanced stages when treatment options are more limited.
Eikon Therapeutics is a late-stage clinical biopharmaceutical company focused on oncology. The company is advancing a pipeline of drug candidates targeting areas of high unmet need.
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