Global Phase 3 Study Launches for Second-Line Non-Small Cell Lung Cancer Vaccine

OSE Immunotherapeutics SA today announced the launch of its international Phase 3 clinical trial (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).

Tedopi® (immunotherapy activating tumor-specific T-cells, off-the-shelf, neoepitope-based) is the most advanced therapeutic cancer vaccine in development.

This pivotal study, accepted in 14 countries by international health agencies (Canada, Europe, U.K., U.S.), supports the registration of the product Tedopi® in parallel with the companion diagnostic for HLA-A2 positive patients.

Nicolas Poirier, CEO of OSE Immunotherapeutics, said in a press release on September 10, 2024, “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 largely 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.

Each year, more people die of lung cancer in the U.S. than of colon, breast, and prostate cancers combined. Lung cancer accounts for about 20% of all cancer deaths.

The American Cancer Society (ACS) estimates for lung cancer cases for 2024 are:

• About 234,580 new cases of lung cancer (116,310 in men and 118,270 in women),
• About 125,070 deaths from lung cancer (65,790 in men and 59,280 in women).

On a positive note, the ACS says the number of deaths from lung cancer continues to decrease due to fewer people smoking and advances in early detection and treatment.