Takeda Pharmaceutical Company Limited announced that FDA approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the first-line setting.
ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations.
The approval is based on results from the Phase 3 ALTA 1L trial, which is evaluating the safety and efficacy of ALUNBRIG compared to crizotinib in adult patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor.
After more than two years of follow-up, results from the ALTA 1L trial showed ALUNBRIG demonstrated superiority over crizotinib, with significant anti-tumor activity observed, especially in patients with baseline brain metastases.
- ALUNBRIG reduced the risk of disease progression or death twofold compared with crizotinib (PFS hazard ratio = 0.49), with a 24-month median progression-free survival (PFS) as assessed by a blinded independent review committee (BIRC) versus 11 months for crizotinib.
- ALUNBRIG demonstrated a confirmed overall response rate (ORR) of 74% (95% CI: 66–81) for ALUNBRIG and 62% (95% CI: 53–70) for crizotinib as assessed by a BIRC.
- ALUNBRIG demonstrated a confirmed intracranial ORR for patients with measurable brain metastases at baseline of 78% (95% CI: 52–94) for patients treated with ALUNBRIG and 26% (95% CI: 10–48) for patients treated with crizotinib.