2024 World Conference on Lung Cancer (WCLC) - Posters-P4.11D.12 Phase 3 Trial of OSE2101 Versus Docetaxel in Patients with Non-Small Cell Lung Cancer & Secondary Resistance to Immunotherapy

P4.11D.12 Phase 3 Trial of OSE2101 Versus Docetaxel in Patients with Non-Small Cell Lung Cancer & Secondary Resistance to Immunotherapy

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The document describes a Phase 3 clinical trial comparing OSE2101 (TEDOPI), a therapeutic cancer vaccine, with docetaxel in patients with Non-Small Cell Lung Cancer (NSCLC) who have developed secondary resistance to immunotherapy. OSE2101 targets Tumor-Associated Antigens (TAAs) and is particularly aimed at patients with the HLA-A2 genotype. Prior Phase 2 trials indicated that a higher T-cell immune response triggered by OSE2101 was linked to improved overall survival in heavily pre-treated advanced NSCLC patients.<br /><br />In the ARTEMIA study, the current Phase 3 trial aims to evaluate the overall survival (OS) as the primary endpoint for all randomized and treated patients. Approximately 363 patients will be enrolled to ensure reaching 269 events, targeting a hazard ratio (HR) of 0.70 with 80% power, and includes an interim analysis for futility. Secondary and exploratory endpoints include safety assessments, quality of life measures, efficacy based on RECIST 1.1 criteria, and biomarkers, such as peripheral blood mononuclear cells, circulating tumor DNA, and analysis of cytokines/chemokines.<br /><br />Preliminary outcomes show that OSE2101 improves median OS to 11.1 months compared to 7.5 months with standard care, with a hazard ratio of 0.57. The 1-year OS rate with OSE2101 is also higher at 44% versus 28% with standard care.<br /><br />The trial is conducted under the ClinicalTrials.gov ID: NCT06472245 and EU CT Number: 2023-509340-10-00. Key contacts include Dr. Stephen V. Liu from Georgetown University, who serves as a principal investigator. The study is sponsored by OSE Immunotherapeutics, with collaboration from various international research centers.

Asset Subtitle

Stephen LIU

Meta Tag

Speaker Stephen LIU

Topic Metastatic NSCLC – Immunotherapy

Keywords

Phase 3 clinical trial

OSE2101

TEDOPI

Non-Small Cell Lung Cancer

NSCLC

immunotherapy resistance

HLA-A2 genotype

overall survival

ARTEMIA study

OSE Immunotherapeutics