OSE Immunotherapeutics SA, a pioneering biotech company in the field of immuno-oncology and immuno-inflammation, has announced hopeful results from its 2:1 randomized phase III clinical trial, known as Atalante-1, involving the T-cell epitope cancer vaccine Tedopi®. The trial focused on patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had experienced secondary resistance to immune checkpoint inhibitors (ICIs).
Tedopi® is a novel T-cell epitope-based cancer vaccine designed to target five tumor-associated antigens, stimulating the expansion of tumor-specific T-cells in HLA-A2 positive cancer patients. According to the investigators, this innovative approach aims to enhance the body’s natural immune response against cancer cells.
The clinical trial, titled “Randomized Open-Label Controlled Study of Cancer Vaccine OSE2101 Versus Chemotherapy in HLA-A2-positive Patients with advanced Non-Small Cell Lung Cancer with Resistance to Immunotherapy: ATALANTE-1,” compared the efficacy and safety of Tedopi® to standard chemotherapy (docetaxel or pemetrexed) in patients who had progressed 12 weeks after receiving both chemotherapy and immune checkpoint inhibitors, with a primary endpoint of overall survival.
“Tedopi® is the first cancer vaccine to demonstrate positive results on survival in a randomized phase three trial in advanced and metastatic NSCLC cancer patients in the third line. A significant reduction of the risk of death by 41 percent was achieved with a better safety profile and a maintained quality of life,” said Benjamin Basse, PhD, director of clinical research at Gustave Roussy Institute (IGR, Villejuif, France), and principal investigator of the Atalante-1 clinical trial.
The results of the phase III trial, published in Annals of Oncology offer hope to patients who had experienced secondary resistance to immunotherapy, a challenging population to treat effectively. The vaccine demonstrated statistically significant improved overall survival with a 44.4 percent overall survival rate at one year, compared to 27.5 percent with chemotherapy.
“Tedopi® is the most advanced therapeutic cancer vaccine in clinical development. These phase three data, demonstrating the promising effects, have now been validated in the internationally recognized journal ‘Annals of Oncology,’ a major achievement for all involved … ,” said Nicolas Poirer, CEO of OSE Immunotherapeutics.
Tedopi® also led to significantly longer post-progression survival, with patients experiencing a median of 7.7 months versus 4.6 months in the chemotherapy group as well as demonstrating a superior safety profile, with fewer severe adverse events compared to chemotherapy. According to the investigators conducting the study, patients receiving the vaccine reported a better quality of life, as measured by various parameters, including global health status and role functioning.
”The clinical value of our results, re-activating specifically the anti-tumor immune responses, is particularly interesting in patients showing immune escape from checkpoint inhibitors. The confirmatory pivotal phase three trial in preparation is planned to support the regulatory registration of Tedopi® in secondary resistance to immune checkpoint inhibitors, this time in second line NSCLC treatment,” Poirer concluded in a press statement.