OSE Immunotherapeutics - Tedopi registrational study commences

OSE Immunotherapeutics has announced the initiation of its Phase III registrational study (Artemia) for lead cancer vaccine Tedopi, with the trial launching in the US, Canada, Europe and the UK. Artemia is a confirmatory pivotal trial designed to assess the efficacy and safety of Tedopi as a monotherapy versus the standard of care (SoC) in HLA-A2 positive patients with metastatic non-small cell lung cancer (NSCLC) and secondary (acquired) resistance to immune checkpoint inhibitors (ICIs). The primary endpoint is overall survival (OS) and we expect top-line results in 2027. If the data are positive, this should support a regulatory registration in the second-line setting in Europe and North America.