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.

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