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.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechLarge CapNewsHealth CareFDAMoversTrading IdeasGeneralBriefsEurasia
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!