
The approval is based on findings from the phase II ALTA trial, in which the confirmed objective response rate for brigatinib at 180 mg daily was 53% (95% CI, 43-62) and the median progression-free survival (PFS) was 13.8 months.
The ALTA trial enrolled 222 patients with ALK-positive NSCLC following progression on crizotinib. Patients were randomized to receive brigatinib at either 90 mg daily (n = 112) or 180 mg daily with a 7-day lead in period at 90 mg per day (n = 110). Sixty-nine percent of patients had brain metastases at the time of enrollment.
The median age of patients across the study was 54 years, and ECOG performance status (PS) was primarily 0 and 1 (93%), with 7% having an ECOG PS of 2. Sixty percent of patients did not have a smoking history prior to entering the trial and 74% had received prior chemotherapy. Sixty-five percent of patients had experienced a complete or partial response to crizotinib. Click here to read the full article at OncLive.com