Brigatinib in Crizotinib-Refractory ALK-Positive Non–Small Cell Lung Cancer
The ALK inhibitor brigatinib showed activity, “robust” progression-free survival, and acceptable safety in patients with ALK-positive non–small cell lung cancer who had been previously treated with crizotinib, according to updated data from the randomized phase II ALTA trial published by Myung-Ju Ahn, MD, of Samsung Hospital, Seoul, South Korea, and colleagues, in the Journal of Clinical Oncology.
A total of 222 patients with crizotinib-refractory advanced ALK-positive NSCLC were stratified by the presence of brain metastases and best response to prior crizotinib. They were randomized 1:1 to receive brigatinib at 90 mg/day in arm A (n=112) or 180 mg/day with a 7-day lead-in at 90 mg in arm B (n=110).
As of May 31, 2016, the objective response rate was 45% in arm A and 55% in arm B. Median progression-free survival was 8.8 months in arm A and 15.6 months in arm B. In patients with measurable baseline brain metastases (A/B, n=26/n=18), confirmed intracranial objective response rate was 46% and 67% in arms A and B, respectively.
Brigatinib demonstrated efficacy in both arms of the study, but the 180-mg dose with the 90 mg lead-in was associated with an improvement in efficacy endpoints with no increase in early pulmonary adverse events, the investigators reported.