FDA panel confirms Imfinzi benefit but queries study design

An advisory panel of the US Food and Drug Administration has questioned the design of a trial for AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab), while confirming that it met the primary efficacy goal.

The Phase III AEGEAN trial achieved the endpoint of event-free survival in treating resectable non-small cell lung cancer (NSCLC), showing an acceptable safety profile.

In the study, certain adults with resectable early-stage NSCLC were administered Imfinzi combined with neoadjuvant chemotherapy before surgery and as a standalone treatment after surgery.