First-line osimertinib boosts OS in EGFR-mutated NSCLC

  • Ramalingam SS & al.
  • N Engl J Med
  • 21 Nov 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Osimertinib yielded longer OS than comparable epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in patents with locally advanced or metastatic untreated NSCLC.

Why this matters

  • Earlier results from this trial indicated a longer PFS with osimertinib, but mature OS data had not yet been reported.

Study design

  • Randomized, double-blind, phase 3 FLAURA trial.
  • 556 patients with EGFR-mutated, untreated locally advanced or metastatic NSCLC received first-line treatment with osimertinib (n=279) or a comparable TKI (n=277).
  • Median follow-up was 35.8 months in the osimertinib group and 27.0 months in the comparator group.
  • Funding: AstraZeneca.

Key results

  • Median OS was significantly longer with osimertinib (38.6 vs 31.8 months; HR for death, 0.80; P=.046).
  • Patients in the osimertinib group were more likely to continue treatment at 12 months (70% vs 47%), 24 months (42% vs 16%), and 36 months (28% vs 9%).
  • OS boost with osimertinib was consistent across most subgroups and was largest in non-Asians (HR for death, 0.54; 95% CI, 0.38-0.77) and patients with exon 19 deletion (HR for death, 0.68; 95% CI, 0.51-0.90).
  • 31% of the comparator group discontinued their treatment and began therapy with osimertinib.
  • Incidence of grade ≥3 adverse events was similar between groups.

Limitations

  • None listed.