• Phase I study (N = 130) evaluating LDK378 in patients with advanced ALK-positive NSCLC
• ORR for crizotinib-naïve and resistant tumors: 60% and 57%
• Most common adverse events were nausea, diarrhea, vomiting and fatigue (mostly Grade 1 and 2)

This critically important presentation represents another important leap forward and significantly adds to the unprecedented recent progress made in managing NSCLC with ALK rearrangements. Most notably, these data reveal that the second-generation tyrosine kinase inhibitor LDK378 has extraordinary activity in patients with ALK-positive disease, including those who have not yet received crizotinib and those whose disease has progressed on crizotinib. Not surprisingly, Phase III trials are already being considered to evaluate how this potentially more potent and selective ALK inhibitor will stack up against crizotinib in untreated cases, but for now all oncologists should be aware of ongoing trials evaluating LDK378 in the event of disease progression in patients receiving targeted therapy.