OSE Immunotherapeutics Receives Second Positive IDMC Recommendation for Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

Core Insights - OSE Immunotherapeutics announced a second positive recommendation from the Independent Data Monitoring Committee (IDMC) for the Phase 3 ARTEMIA trial evaluating Tedopi® in advanced non-small cell lung cancer (NSCLC) [1][2] Group 1: Trial Progress and Recommendations - The IDMC conducted a comprehensive assessment of patient safety, trial conduct, and key efficacy indicators, recommending that the study continue without modifications, confirming the robustness of the trial's conduct to date [2] - As of the IDMC meeting, a total of 163 patients had been randomized, with 152 included in the analysis reviewed by the IDMC, aligning with recruitment objectives [3] Group 2: Trial Design and Objectives - The ARTEMIA trial, initiated in 2024, compares Tedopi® monotherapy with standard docetaxel in HLA-A2–positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors [3] - The trial is enrolling across sites in Europe, the UK, the US, and Canada, designed to generate confirmatory data to support potential regulatory filings [3] Group 3: Future Milestones - The next IDMC review is scheduled for October 2026, with study enrollment expected to conclude by year-end 2026 [4] - An interim futility analysis for the Tedopi® NSCLC pivotal Phase 3 trial is expected in Q3 2026, with overall survival primary endpoint results anticipated in Q1 2028 [4]