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