- 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.
- 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.
- 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).
- Time to worsening of global health status/QoL scores was longer with brigatinib: HR, 0.70 (P=.049).
- Open-label study.