ESMO 2020 — Osimertinib is highly effective in EGFR mutation-positive resectable NSCLC


  • Michael Simm
  • Oncology Conference reports
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Takeaway

  • Adjuvant osimertinib doubled the proportion of successfully resected patients with epidermal growth factor receptor (EGFR)-mutated NSCLC who were still alive after 2 years, in comparison to placebo.
  • Central nervous system (CNS) disease was absent in 98% of patients given osimertinib.

Why this matters

  • Approximately 30% of patients with NSCLC present with resectable disease, but rates of recurrence after surgery remain high.
  • For patients with EGFR-mutated NSCLC, tyrosine kinase inhibitors may have a role in this setting.
  • In the phase 3 ADAURA study, an improvement in DFS has been demonstrated for osimertinib.

Study design

  • ADAURA is a double-blind phase 3 trial including 682 patients with completely resected EGFR mutation-positive NSCLC who were randomly assigned to receive osimertinib (80 mg once daily) or placebo for 3 years.
  • Primary and secondary endpoints were DFS among patients with stage II to IIIA disease and stage IB to IIIA, respectively.
  • Funding: AstraZeneca.

Key results

  • Primary endpoint, at 24 months:
    • 90% with osimertinib vs 44% with placebo were alive and disease-free.
    • HR, 0.17 (99.06% CI, 0.11-0.26).
  • Secondary endpoint:
    • 89% osimertinib vs 52% placebo were alive and disease-free.
    • HR, 0.20 (99.12% CI, 0.14-0.30).
  • Also at 24 months, the proportion of patients alive without CNS disease:
    • 98% with osimertinib vs 
    • 85% with placebo,
    • HR, 0.18 (95% CI, 0.10-0.33).
  • Overall survival data were immature, but of 29 patients who died, 9 were in the osimertinib group and 20 were in the placebo group.

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