AstraZeneca's Imfinzi Combo Scores FDA Approval For Liver Cancer

AstraZeneca's Imfinzi Combo Scores FDA Approval For Liver Cancer
  • The FDA has approved AstraZeneca Plc's AZN Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
  • The novel dose and schedule of the combination includes a single dose of the anti-CTLA-4 antibody Imjudo 300mg added to the anti-PD-L1 antibody Imfinzi 1500mg, followed by Imfinzi every four weeks, dubbed the STRIDE regimen.
  • The approval was based on positive results from the HIMALAYA Phase 3 trial. 
  • In this trial, patients treated with the combination of Imjudo and Imfinzi experienced a 22% reduction in the risk of death versus sorafenib.
  • Results were also published in the New England Journal of Medicine Evidence showing that an estimated 31% of patients treated with the combination were still alive after three years, with 20% of patients treated with sorafenib.
  • The safety profiles of the combination of Imjudo added to Imfinzi and for Imfinzi alone were consistent with the known profiles of each medicine, and no new safety signals were identified.
  • Price Action: AZN shares are up 0.44% at $55.21 during the premarket session on the last check Monday.
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