The Independent Data Monitoring Committee (IDMC) has approved the continuation of the Phase III clinical study into OSE Immunotherapeutics’ treatment for Non-Small Cell Lung Cancer (NSCLC) — Tedopi — after immune checkpoint inhibitor treatment.
approval
“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,” stated Alexis Peyroles, CEO of OSE Immunotherapeutics. “Our Tedopi neoepitope product is well positioned to benefit NSCLC patients experiencing treatmentfailure aftercheckpoint inhibitors, as there is currently no approved treatment for these patients.”
The Tedopi Phase III clinical trial — Atalante 1 — is evaluating the benefit of the treatment in HLA-A2 positive patients with NSCLC at invasive stage IIIB or metastatic stage IV who are in second or third line treatment following the failure of a checkpoint inhibitor. The treatment will be compared to the current standard chemotherapy treatments in this patient population with the primary endpoint being overall survival.
This international trial is being conducted at sites in the US, Europe and Israel.