AstraZeneca Drug Imfinzi Fails As Monotherapy In Metastatic Lung Cancer Setting

AstraZeneca Plc AZN announced topline data from the PEARL Phase 3 trial of Imfinzi (durvalumab) monotherapy versus platinum-based chemotherapy (investigator's choice) as a 1st-line treatment in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).
The study did not achieve statistical significance for the primary endpoints of improving overall survival (OS) versus platinum-based chemotherapy as a monotherapy treatment for metastatic NSCLC whose tumor cells express high levels of PD-L1 or in a subgroup of patients at low risk of early mortality.
Related: FDA Approves AstraZeneca's Imfinzi/Imjudo Chemo Combo For Late Stage Lung Cancer.
There was an improvement in OS with Imfinzi monotherapy, which was clinically meaningful in the subset of patients with PD-L1 tumor expression greater than 50%, a secondary endpoint.
The trial was conducted primarily in Asia.
The safety and tolerability profile for Imfinzi was broadly consistent with the known profile of the medicine, and no new safety signals were identified.
Price Action: AZN shares closed lower by 2.58% at $67.94 on Friday.