FDA Approves AstraZeneca's Imfinzi/Imjudo Chemo Combo For Late Stage Lung Cancer

FDA Approves AstraZeneca's Imfinzi/Imjudo Chemo Combo For Late Stage Lung Cancer
  • The FDA has approved AstraZeneca plc’s AZN Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy for Stage IV (metastatic) non-small cell lung cancer (NSCLC).
  • The approval was based on the results from the POSEIDON Phase 3 trial. Patients treated with a limited course of five cycles of the anti-CTLA-4 antibody Imjudo added to Imfinzi plus four cycles of platinum-based chemotherapy experienced a 23% reduction in the risk of death versus a range of chemotherapy options.
  • An estimated 33% of patients were alive at two years versus 22% for chemotherapy. This treatment combination also reduced the risk of disease progression or death by 28% compared to chemotherapy alone.
  • Updated results from the POSEIDON Phase 3 trial after approximately four years of follow-up demonstrated sustained survival benefit, improving overall survival (OS) by 25% compared to chemotherapy alone. 
  • An estimated 25% of patients treated with the combination were alive at three years versus 13.6% for those treated with chemotherapy alone. 
  • Price Action: AZN shares are down 1.51% at $64.11 during the premarket session on the last check Friday.
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