OSE Immunotherapeutics: Positive Opinion for ARTEMIA Trial
OSE Immunotherapeutics announces the receipt of a second positive opinion from the Independent Data Monitoring Committee (IDMC) for its pivotal Phase 3 ARTEMIA trial, assessing Tedopi® in non-small cell lung cancer. The committee recommends continuing the study without any protocol modifications.
IDMC's Comprehensive Review
The IDMC, consisting of independent clinical experts and statisticians, analyzed the available data to assess patient safety, trial progression, and key efficacy indicators. Based on this analysis, the committee recommends the continuation of the ARTEMIA study without modifications, confirming the robustness of the proceedings to date. According to OSE Immunotherapeutics, 163 patients had been randomized as of the IDMC meeting date, and the first 152 patients were reviewed in the analysis. The company states that these figures are in line with its recruitment goals.
Details of the ARTEMIA Trial
Launched in 2024, the ARTEMIA trial compares Tedopi® to docetaxel in HLA-A2 positive patients with metastatic stage non-small cell lung cancer who have developed secondary resistance to immune checkpoint inhibitors. Participating centers are open in Europe, the United Kingdom, the United States, and Canada. The next IDMC review is scheduled for October 2026, and patient enrollment is expected to be completed by the end of 2026. An interim futility analysis is anticipated in the third quarter of 2026.
