OSE Immunotherapeutics - FDA support received for Tedopi Phase III trial

OSE has announced that it has received positive recommendations from its ‘type C’ meeting with the FDA for the planned confirmatory Phase III trial design for Tedopi (neoepitope cancer vaccine), as a second-line treatment in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure. This follows similar advice from the European Medicines Agency (EMA). The company will now undertake the pivotal trial as monotherapy (against standard of care) under this protocol, for patients with HLA-A2+ tumours (c 45% of total population). As a reminder, OSE reported positive data from the previous Phase III ATALANTE-1 trial as second/third-line treatment, although enrolment had to be terminated prematurely due to the COVID-19 pandemic.