Regulatory update provided on the clinical development plan of Tedopi® in Ph 3 in monotherapy in advanced or mNSCLC after checkpoint inhibitor failure
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are pleased with the positive outcomes from the US Food & Drug Administration (FDA) Type C Meeting following the supportive European Medicines Agency (EMA) advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi®. Leveraging on the positive data on efficacy, safety and quality of life from the initial phase 3 randomized trial in third line post-chemotherapy followed by an immune checkpoint inhibitor (ICI), we are committed in advancing the clinical development for Tedopi® as a potential new standard of care in monotherapy in second line for advanced or metastatic lung cancer patients in secondary resistance to ICI now used in first line. No therapeutic options have yet been approved to date in this patient population with high unmet medical needs.”
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