OSE Immunotherapeutics Announces Global Launch of Artemia Phase 3 Registration Study for Cancer Vaccine Tedopi® in Second-Line Non-Small Cell Lung Cancer

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OSE Immunotherapeutics
OSE Immunotherapeutics

OSE Immunotherapeutics Announces Global Launch of Artemia Phase 3 Registration Study for Cancer Vaccine Tedopi® in
Second-Line Non-Small Cell Lung Cancer

  • Trial begins in the United States, Canada, Europe and United Kingdom after successful regulatory authorizations in 14 countries.

  • Trial in Progress presentation at the 2024 World Conference on Lung Cancer in San Diego and at the European Society for Medical Oncology congress 2024 in Barcelona.

Nantes, France – September 10, 2024 – 7:30 am CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced the launch of its international Phase 3 clinical trial named ‘Artemia’ of Tedopi®, the ‘off-the-shelf’ neoepitope-based therapeutic cancer vaccine, in second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC). This dossier, reviewed and accepted in 14 countries by international health agencies (US FDA, Canada, Europe and the United Kingdom) is a pivotal study supporting the registration of the product Tedopi®, in parallel with the companion diagnostic for HLA-A2 positive patients.

Artemia is an international, randomized, open-label Phase 3 trial comparing the efficacy and safety of Tedopi® monotherapy versus standard of care in HLA-A2 positive patients with metastatic NSCLC with secondary resistance* to immune checkpoint inhibitor (ICI). The primary endpoint is overall survival. This confirmatory pivotal trial will include 363 patients, and aims at supporting the regulatory registration of Tedopi® in second-line treatment of NSCLC in Europe and North America.

Silvia Comis, Head of Clinical development and Regulatory affairs of OSE Immunotherapeutics, comments: “We are very pleased to start the last registration development step of our cancer vaccine Tedopi® in monotherapy in second-line treatment, supported by the positive and promising results from our first Phase 3 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.“

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: “This international registration trial is now on track, and we look 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. “

NSCLC accounts for 85% of all lung cancers** and the HLA-A2 phenotype represents about 45% of the population. Based on selection of patients after ICI failure data, the targeted population for Tedopi® in second line is hence considered as rare with high unmet medical needs. Given the large use of anti-PD(L)1 and based on ICI failure data, the targeted population for Tedopi® in second line could be estimated up to 46,000 patients per year in seven major markets across the US, Europe and Japan.