Brigatinib (1) – Alunbrig®

• Clinical trials
  • The ALTA trial was a two-arm, open-label, phase II randomised controlled trial (RCT) that enrolled patients with crizotinib-pretreated, ALK-positive, locally advanced or metastatic NSCLC; prior treatment with chemotherapy was also permitted.
  • The ASCEND-5 trial is a two-arm, open-label, phase IIIRCT that enrolled patients with ALK-positive, locally advanced or metastatic NSCLC who, according to the inclusion criteria, had to have previously been treated with crizotinib and one or two courses of chemotherapy (including ≥ 1 platinum-based chemotherapy).
  • The AP26113-11-101 is a non-randomised, uncontrolled dose-finding study of brigatinib involving 137 adult patients with various tumour types, 25 of whom fall within the current therapeutic indication and who received brigatinib at the authorised dose.
  • The ALTA-1L study is an open-label RCT directly comparing brigatinib with crizotinib in patients with ALK-positive, locally advanced or metastatic NSCLC who had not previously been treated with a tyrosine kinase inhibitor.

a) Adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC) who have previously been treated with crizotinib

• The additional benefit is not proven.
• As there are no data available to enable an assessment of additional benefit, additional benefit is not proven for brigatinib as monotherapy in the treatment of adult patients with ALK-positive, advanced NSCLC who have previously been treated with crizotinib.

Courtesy translation only, please refer to the German original.