On July 2, 2018 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) received approval from the Independent Data Monitoring Committee (IDMC) to continue Atalante 1, the Company’s international pivotal Phase 3 clinical study of Tedopi for the treatment of Non-Small Cell Lung Cancer (NSCLC) following immune checkpoint inhibitor treatment (Press release, OSE Immunotherapeutics, JUL 2, 2018, View Source [SID1234528562]).
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" While checkpoint inhibitors are now considered as the standard of care in first- and second-line treatment of advanced NSCLC, there is a strong clinical need for patients in immune escape after such treatment. Our Tedopi neoepitope product is well positioned to benefit NSCLC patients experiencing treatment failure after checkpoint inhibitors, as there is currently no approved treatment for these patients," said Alexis Peyroles, CEO of OSE Immunotherapeutics.
The Tedopi Phase 3 trial, Atalante 1, is evaluating the benefit of Tedopi in HLA-A2 positive patients with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following failure of a checkpoint inhibitor, compared to current standard chemotherapy treatments in this patient population. The primary endpoint of the trial is overall survival. This international trial is being conducted in the U.S., in Europe and in Israel.