ALK+ NSCLC: brigatinib continues to outperform crizotinib

  • Camidge DR & al.
  • J Clin Oncol
  • 11 Aug 2020

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Patients with locally advanced anaplastic lymphoma kinase-positive (ALK+) NSCLC treated with first-line brigatinib had significantly better PFS in this phase 3 study than those who received crizotinib.
  • Intracranial objective response rate (ORR) was also better with brigatinib.

Why this matters

  • The findings are from the second interim analysis of the ALTA-1L phase 3 trial of brigatinib, which received FDA approval for metastatic ALK+ NSCLC earlier this year.

Study design

  • Randomized, international, phase 3 ALTA-1L study.
  • 275 patients with previously untreated locally advanced metastatic ALK+ NSCLC were treated with brigatinib (n=137) or crizotinib (n=138).
  • Median follow-ups of 24.9 months for the brigatinib group and 15.2 months for the crizotinib group.
  • Funding: ARIAD Pharmaceuticals.

Key results

  • PFS was significantly better with brigatinib vs crizotinib:
    • 48% vs 26%.
    • HR, 0.49 (P<.0001>
  • ORR was better with brigatinib: 74% vs 62%.
  • PFS was significantly better with brigatinib in patients:
    • With baseline brain metastases: HR, 0.25 (P<.0001>
    • Without: HR, 0.65 (P=.030).
  • In patients with measurable brain metastases, intracranial ORR was 78% with brigatinib vs 26% with crizotinib.
    • Time to worsening of global health status/QoL scores was longer with brigatinib: HR, 0.70 (P=.049).
  • No significant difference between groups in 2-year OS.
  • No new safety events.

Limitations

  • Open-label study.