Lung Cancer Vaccine Gains Agency Support
OSE Immunotherapeutics SA today provided a regulatory update on the clinical development plan of Tedopi®, a immunotherapy activating tumor-specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (ICI).
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, commented in a press release on February 15, 2023, “We are pleased with the positive outcomes from the US Food & Drug Administration Type C Meeting following the supportive European Medicines Agency advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi®."
Both Agencies supported the continuation of the clinical development for Tedopi® through a new confirmatory phase 3 clinical trial versus standard of care in second-line treatment for HLA-A2+ patients in advanced in NSCLC.
Tedopi® is the first cancer vaccine to show positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in the third line with secondary resistance to ICI in advanced or metastatic NSCLC.