In September 2024, OSE Immunotherapeutics announced the launch of an international Phase III clinical trial of its off-the-shelf neoepitope-based therapeutic cancer vaccine, Tedopi. The trial, named ‘Artemia’, will compare the efficacy and safety of Tedopi monotherapy with the standard of care in HLA-A2 positive patients with metastatic non-small cell lung cancer (NSCLC) with secondary resistance to immune checkpoint inhibitor (ICI). The primary endpoint is overall survival.
Tedopi and the Artemia trial
NSCLC accounts for 85% of all lung cancers, and the HLA-A2 phenotype represents around 45% of the population. The target population for Tedopi in second line is “considered as rare with high unmet medical needs”. This could be up to 46,000 patients a year across “seven major markets”.
Tedopi is a novel T-cell epitope-based cancer vaccine that targets five tumour-associated antigens. It is an activating and differentiated off-the-shelf immunotherapy expanding tumour specific T-lymphocytes in HLA-A2 cancer patients. It is being investigated in several Phase II trials as well as Artemia, a confirmatory Phase III clinical trial. This is intended to support the registration of Tedopi in second-line treatment of NSCLC in Europe and North America, alongside the companion diagnostic test for HLA-A2 positive patients.
Artemia is an international, randomised, open-label Phase III trial in the United States, Canada, Europe, and the United Kingdom. It is expected to include 363 patients.
Extending survival
Dr Silvia Comis, Head of Clinical Development and Regulatory Affairs at OSE Immunotherapeutics is “very pleased” that the last registration development step of the vaccine has started, supported by “positive and promising results” from the first Phase III in third-line treatment in NSCLC.
“These results demonstrated that re-arming the immune system with vaccine in metastatic patients can extend survival and preserve quality of life in the targeted population.”
Dr Nicolas Poirier, OSE Immunotherapeutics’ Chief Executive Officer looks forward to “confirming the therapeutic benefit of Tedopi for metastatic cancer patients”.
“Tedopi is the most advanced therapeutic cancer vaccine in clinical development and the first treatment option to address the high unmet medical need and large untapped market in advanced and metastatic second-line NSCLC.”
Dr Stephen Liu, associate professor and director of Thoracic Oncology at Georgetown University Lombardi Comprehensive Cancer Centre, is coordinating investigator for the United States and Steering Committee member. Dr Liu is “excited to see the Artemia trial activated in the US”.
“With an off-the shelf vaccine approach, we can offer a safer and more tolerable approach than chemotherapy for patients with advanced lung cancer. By properly engaging a patient’s own immune system, we hope to significantly extend survival.”
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