The efficacy and safety of ALECENSA were established in the head-to-head, global, open-label, randomized Phase 3 ALEX trial of 303 first-line patients with stage IIIB/IV ALK+ NSCLC vs crizotinib. The primary efficacy endpoint was PFS as determined by Investigator (HR=0.48 [95% CI: 0.35, 0.66]; P<0.0001) based on RECIST v1.1. Additional efficacy endpoints included PFS by IRC based on RECIST v1.1 (HR=0.53 [95% CI: 0.38, 0.73]; P<0.0001) and time to cause-specific CNS progression (HR=0.16 [95% CI: 0.10, 0.28]; P<0.0001). Time to cause-specific CNS progression was defined as CNS as the first site of progression alone or with concurrent systemic progression. Patients who first progressed systemically and patients with death prior to CNS or systemic progression were not included as events. 1-3

aWhen an ALK rearrangement is discovered prior to first-line systemic therapy.
bThe NCCN Guidelines for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques, but do not endorse any specific commercially available biomarker assays.

1L=first-line; CI=confidence interval; CNS=central nervous system; HR=hazard ratio; IRC=Independent Review Committee; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.

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