- 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.
- 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.
- 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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