Rosario Campelo, MD of University Hospital of A Coruña discusses ALUNBRIG (brigatinib) as a first-line treatment for ALK + non-small cell lung cancer.
ALUNBRIG's Phase 3 ALTA-1L (ALK in BrigAtinib's Lung Cancer Trial in 1st line) study in adults is a global, ongoing, randomized, open-label, comparative, multicenter study that enrolled 275 patients (ALUNBRIG, n=137, crizotinib, n=138) with ALK+ locally advanced or metastatic NSCLC who did not receive an ALK inhibitor prior care. Patients received either ALUNBRIG, 180 mg once daily at 90 mg once daily with seven-day lead-in, or crizotinib, 250 mg twice daily.
In the ALUNBRIG arm the median age was 58 years and in the crizotinib arm was 60. Twenty-nine per cent of patients in the ALUNBRIG arm had brain metastases at baseline against 30% in the crizotinib arm. Twenty-six per cent of patients received advanced or metastatic disease prior chemotherapy in the ALUNBRIG arm against 27 per cent in the crizotinib arm.
The primary endpoint was Blinded Independent Evaluation Committee (BIRC), assessed progression-free survival (PFS). Secondary endpoints included RECIST v1.1 objective response rate (ORR), intracranial ORR, intracranial PFS, overall survival (OS), safety, and tolerability.