31May

Takeda published brigatinib data from J-ALTA study to supprt its approval in Japanese patients

Brigatinib in Japanese ALK positive NSCLC patients previously treated with ALK tyrosine kinase inhibitors: J-ALTA


Abstract No : 9537

Abstract Type : Poster Session

Indication : ALK positive NSCLC

Intervention : Brigatinib

Company : Takeda Pharmaceutical Company

Technology : Small molecule


Results:

A total of 72 patients were enrolled in 28 sites, including a cohort of 47 patients with prior alectinib, with/without crizotinib between January 2018 and September 2019. The primary analysis of brigatinib in this cohort (data cut-off date 26 September 2019) demonstrated an IRC-assessed, confirmed ORR of 30% and a median DoR of 6.1 months. The median PFS was 7.3 months. Clinically meaningful intracranial efficacy was also observed (see table). Grade $3 TEAEs included blood creatine phosphokinase increase (18.1%), lipase increase (13.9%), hypertension (11.1%), amylase increase (4.2%), and pneumonitis (1.4%). Brigatinib also showed anti-tumor activity in patients with refractory secondary mutations in the ALK kinase domain, including G1202R, I1171N, V1180L, and L1196M.


Conclusion:

Brigatinib showed clinically meaningful efficacy in Japanese patients refractory to prior alectinib (first line or post crizotinib), regardless of prior chemotherapy. The safety profile of brigatinib was consistent with prior studies and no new safety findings were identified.


Commentary:

Brigatinib showed clinically meaningful efficacy in Japanese patients refractory to prior alectinib (first line or post crizotinib), regardless of prior chemotherapy. Takeda submitted a new drug application in Japan for its ALK inhibitor brigatinib for the treatment of ALK-positive non-small cell lung cancer (NSCLC).


Refer to ALK positive NSCLC Market report for detailed Insights.