ALK-positive NSCLC: positive phase 2 results with ensartinib

  • Lancet Respir Med

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • Ensartinib yielded good response rates in a phase 2 trial of patients with locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive NSCLC who progressed after taking crizotinib, with an acceptable safety profile.

Why this matters

  • A randomized phase 2 trial of ensartinib vs crizotinib in patients with NSCLC who have not received treatment with ALK tyrosine kinase inhibitors.

Study design

  • International, multicenter phase 2 trial.
  • 156 patients with stage IIIb or IV ALK-positive NSCLC received ensartinib.
  • Median follow-up, 294 days.
  • Funding: Betta Pharmaceuticals.

Key results

  • 52% had an objective response, 93% had disease control, and 82% had a reduced tumor burden from baseline.
  • Median PFS was 9.6 (95% CI, 7.4-11.6) months; median OS was not reached.
  • 62% had disease progression or died.
  • Among patients with baseline brain metastases, 41% had an objective response, 70% had an objective intracranial response, and 98% had intracranial disease control.
  • At data cutoff, 23% of patients had central nervous system disease progression.
  • 91% of patients had ≥1 treatment-related adverse event (AE), 23% had grade 3 treatment-related AEs, and 26% had serious AEs.
  • Most common AEs were rash, increased alanine aminotransferase concentrations, and increased aspartate aminotransferase concentrations.

Limitations

  • Single-group, open-label study with short follow-up.