Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non–small cell lung cancer (NSCLC): Efficacy updates and exploratory analysis of CNS ORR and overall ORR by baseline (BL) brain lesion status.

Abstract

9061Background: ALTA (NCT02094573) evaluated 2 doses of the ALK inhibitor BRG post-CRZ. Overall ORR contains both CNS and extra-CNS target lesion data. Methods: In ALTA, stratification included BL CNS disease (+/−). Pts were randomized to BRG 90 mg qd (arm A) or 180 mg qd with a 7-day lead-in at 90 mg (arm B). To differentiate CNS and extra-CNS efficacy we compared CNS ORR with overall ORR by BL CNS status. Results: 222 pts were randomized (n = 112/110, arm A/B); 71%/67% had BL CNS lesions. Of 247/204 total target lesions in A/B, 38 (15%) and 32 (16%), respectively, were in the CNS; 28 (25%) pts in A and 23 (21%) in B had ≥1 target CNS lesion. Median follow-up was 19.6/24.3 mo. Per independent review, CNS ORR in pts with measurable BL CNS lesions (n = 26/18, A/B) was 50%/67%; in pts with any BL CNS lesions (n = 81/74, A/B), median intracranial PFS (iPFS) was 12.8/18.4 mo. Table shows long-term overall efficacy updates by BL CNS status. Dose reductions or discontinuations due to AEs (A/B): 7%/29% and 4%/11...