OSE Immunotherapeutics SA has announced the commencement of the Artemia Phase 3 clinical trial for its cancer vaccine, Tedopi®, targeting second-line treatment of metastatic non-small cell lung cancer (NSCLC). The international, randomized, open-label study will assess the efficacy and safety of Tedopi® monotherapy versus standard of care in HLA-A2 positive patients who have developed secondary resistance to immune checkpoint inhibitors (ICI). With regulatory authorizations secured in 14 countries across the United States, Canada, Europe, and the United Kingdom, the trial is a pivotal step toward the potential registration of Tedopi®.
The Artemia trial aims to enroll 363 patients and focuses on overall survival as the primary endpoint. Secondary endpoints include progression-free survival, objective response rate, and safety. The trial design supports the regulatory registration of Tedopi® for second-line NSCLC treatment in Europe and North America, addressing a significant unmet need in patients who have progressed after ICI therapy.
Expert Commentary
Dr. Stephen Liu, coordinating investigator for the United States and member of the Steering committee of the Artemia trial, presented a Trial in Progress poster at the 2024 World Conference on Lung Cancer. He stated, "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."
Addressing Unmet Needs in NSCLC
NSCLC accounts for approximately 85% of all lung cancer cases, with the HLA-A2 phenotype present in about 45% of the population. The target population for Tedopi® in second-line treatment, selected based on ICI failure data, represents a rare subset with substantial unmet medical needs. Estimates suggest that this population could include up to 46,000 patients per year across major markets in the US, Europe, and Japan.
Tedopi®: A Neoepitope-Based Cancer Vaccine
Tedopi® is an off-the-shelf, neoepitope-based therapeutic cancer vaccine designed to activate tumor-specific T-cells. It has shown promising results in a previous Phase 3 trial (Atalante 1) in third-line NSCLC patients with secondary resistance after checkpoint inhibitor failure. The Artemia trial seeks to confirm these findings in a second-line setting, potentially offering a new treatment option for patients with limited alternatives.
Trial Design and Endpoints
The Phase 3 Artemia trial is designed as an international, randomized, open-label study. Patients with metastatic NSCLC who are HLA-A2 positive and have experienced secondary resistance to ICI therapy are eligible for enrollment. The primary endpoint is overall survival, with secondary endpoints including progression-free survival, objective response rate, and safety. The trial aims to provide robust data supporting the regulatory approval of Tedopi® in second-line NSCLC.
