Pooled Mutation Analysis For The Np28673 And Np28761 Studies Of Alectinib In Alk Plus Non-Small-Cell Lung Cancer (Nsclc).

9061Background: TheALK inhibitor alectinib is FDA-approved for the treatment of patients (pts) with ALK+ NSCLC who have progressed on, or are intolerant to, crizotinib, based on the NP28673 (NCT01801111) and NP28761 (NCT01871805) trials. Long-term effectiveness of ALK inhibitors can be limited by ALK resistance mutations that occur on treatment. This mutation analysis assessed the efficacy of alectinib on different ALK point mutations using pooled data from these two pivotal studies. Methods: The global NP28673 and North American NP28761 studies enrolled pts with ALK+ NSCLC who had progressed on crizotinib. All pts received 600 mg oral alectinib twice daily. Optional tissue and plasma samples were collected for exploratory ALK mutation analyses using next-generation sequencing methods including CAPP-Seq. Results: For most pts, tissue samples were available at baseline (after crizotinib, before alectinib), with only two tissue samples obtained after progression on alectinib. For NP28673, tissue was availab...