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EML4-ALK in non-small-cell lung cancer: the breathtaking progress from benchtop to Phase III clinical trial

Geoffrey Y Ku and Gilberto de Lima Lopes Jr

EML4-ALK is a fusion oncogene found in approximately 5% of patients with non-small-cell lung cancer. It was first discovered in 2007, and is found predominantly in those who never smoke or light smokers (≤10 pack/year tobacco history), younger patients and those with adenocarcinoma histology. It occurs almost exclusively in patients without mutations in K-ras or EGFR. Completed Phase I and II trials suggest significant clinical activity of an ALK kinase inhibitor, PF‑02341066 (crizotinib), in patients with advanced non-small-cell lung cancer who harbor an ALK translocation. A Phase III evaluation of crizotinib versus chemotherapy in the second-line setting is ongoing.