OSE Immunotherapeutics received US Institutional Review Boards approval to continue recruiting patients for the temporarily paused Phase III testing of Tedopi, their immunotherapy for advanced lung cancer.
OSE Immunotherapeutics, based in Nantes, develops immunotherapies to treat a variety of diseases. Its Phase III trial of Tedopi, a lung cancer vaccine, was temporarily paused in June 2017 to optimize the targeted patient group. OSE has received US approval to resume the trial only in patients who do not respond to checkpoint inhibitors.
Tedopi uses a patented combination of 10 antigens to activate specific white blood cells and target cancer cells expressing the antigens. The Atalante 1 trial’s goal is to compare the effectiveness of Tedopi to conventional chemotherapies in treating advanced to metastatic lung cancer.
Patient recruitment for the trial was temporarily paused in June 2017 to investigate how the patient profile relates to treatment efficacy in patients already enrolled in the study. Following the announcement, OSE stock prices plummeted and a recovery appears to be nowhere in sight. Given the crowded market for non-small lung cancer, these developments do not bear well for OSE.
OSE plans to resume patient recruitment under a revised protocol in the US by focusing on patients who have failed a previous treatment with PD-1/PD-L1 immune checkpoint inhibitors. It remains to be seen whether their new approach enjoys success.
Checkpoint inhibitors have changed our outlook in treating cancer. In lung cancer, they have been shown to improve the overall survival compared to standard chemotherapy in patients in which the disease is advanced. However, checkpoint inhibitors are not effective in every patient.
Lung cancer causes almost 1.6 million deaths globally each year. As with other cancers, there is variability in how lung cancer manifests itself on a molecular and cellular level. Along with the stage at which the cancer is detected, this influences the choice of treatment.
If the Atalante 1 trial results are positive, Tedopi could address the need of lung cancer patients who do not respond to combination therapies of a checkpoint inhibitor and chemotherapy.
Images by Sergey Nivens, David Litman/Shutterstock
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