ALTA-1 trial of brigatinib in ALK-adapted non-small cell lung cancer

Similar toThe ALEX study used a similar comparison group. Brigatinib/Brigatinib started at 90mg and then increased to 180mg, compared with crizotinib. An improvement in progression-free survival (PFS) was observed; the hazard ratio was 0.48 (95% CI, 0.35-0.66; P < .0001); the Kaplan-Meier curve was considered to be very similar to that of the ALEX trial.

If you look at brain metastases at baseline, this group of patients seemed to get a significant benefit from treatment with brigatinib versus crizotinib. If we look at intracranial PFS in those patients with brain metastases, the number of these patients is small, but the HR is 0.29 [95% CI, 0.17-0.51; P<.0001]. For those taking brigatinib and crizotinib, median PFS was 2 years [5.6 months, respectively]. So, essentially, if a patient treated with brigatinib has brain metastases at baseline, the brain metastases are controllable nearly 2 years before treatment.

The objective response rate (ORR) of brigatinib was 74%, while that of crizotinib was only 62% [OR, 1.73; 95% CI, 1.04-2.88; P=.0342]. The brain ORRs of brigatiniband crizotinib were 78% and 26% respectively [OR, 11.67; 95%CI, 2.15-63.27; P=.00014]. For brigatinibadverse events (AEs), some creatine phosphokinase elevations and liver function test (LFT) abnormalities were observed.