Activity and safety of brigatinib (BRG) in patients (pts) with ALK+ non-small cell lung cancer (NSCLC): Phase (ph) 1/2 trial results.

9057Background: BRG, an investigational oral tyrosine kinase inhibitor, has preclinical activity against ALK-rearranged NSCLC and mutants resistant to crizotinib (CRZ). Methods: Pts with advanced malignancies, including ALK+ NSCLC, received oral BRG (30–300 mg total daily) in an ongoing ph 1/2, single-arm, open-label, multicenter trial (NCT01449461). Activity (by RECIST v1.1) and safety are reported in ALK+ NSCLC pts and all treated pts, respectively. Results: 137 pts were enrolled. Among 79 ALK+ NSCLC pts, median age was 54 y, 49% were female, and 90% received prior CRZ. As of 15 Jun 2015, 39/79 (49%) ALK+ NSCLC pts remained on study; median duration of treatment was 15.4 mo (1 d–39.4 mo). Among ALK+ NSCLC pts with prior CRZ exposure, the objective response rate (ORR) was 72% (95% CI 60–82%; 51/71, including 44 confirmed responses); for CRZ-treated pts who received dosing regimens explored in ph 2, 90 mg qd, 90 mg qd for 7 d followed by 180 mg qd (90→180 mg qd), and 180 mg total daily, the ORR was 77% (9...