AstraZeneca, Merck Lynparza Earns Win in Early Breast Cancer, Showing Potential in Post-Surgery Setting

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  • AstraZeneca Plc AZN and Merck & Co Inc MRK have announced the first presentation of data from the Phase 3 OlympiA trial evaluating Lynparza (olaparib) in a subset of early breast cancer patients.
  • Results will be presented at the 2021 American Society of Clinical Oncology Annual Meeting and published in the New England Journal of Medicine.
  • Using Lynparza after surgery in high-risk, HER2-negative early breast cancer reduced the risk of disease recurrence or death by 42% over placebo.
  • The results from the phase 3 trial were for patients whose tumors bear BRCA 1/2 mutations.
  • About 85.9% of Lynparza patients were still alive without invasive breast cancer at three years, compared with 77.1% in the placebo group.
  • Lynparza also showed it could reduce the risk of distant tumor recurrence or death by 43%.
  • OS was still too early to determine, with 59 deaths in the Lynparza arm at three years compared with 86 on placebo, but the survival curve was trending in Lynparza’s favor with a 32% reduction in the risk of death.
  • The study remains ongoing to read out the overall survival data.
  • Lynparza posted a similar safety profile to other studies, AstraZeneca said, with 57% of patients on the drug reporting nausea and 40% fatigue — the most common side effects. 9% of patients reported grade 3 or higher anemia, and 5% reported serious neutropenia.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: MRK shares closed at $73.91 on Thursday, while AZN shares are down 0.04% at $56.23 during the premarket session on the last check Friday.
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Posted In: BiotechNewsHealth CareFDAGeneralbreast cancerBriefs
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