The ALK inhibitor alectinib (Alecensa) appears to have superior efficacy and tolerability compared with crizotinib (Xalkori) and may represent a new standard of care for patients with treatment-naïve ALK-positive non-small cell lung cancer (NSCLC), according to data presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. 

New findings from a phase 3 clinical trial comparing the current standard of care with the newer ALK inhibitor, alectinib halted cancer growth for a median of 15 months longer and caused fewer severe adverse effects.

Study results showed that alectinib was especially beneficial in controlling and preventing brain metastases. Crizotinib, the first medicine to specifically target ALK, was approved by the FDA in 2011. Although the majority of patients initially benefit from crizotinib, the cancer typically starts growing again within a year. Alectinib is a more potent, next-generation inhibitor of ALK.

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In this open label clinical trial (ALEX), researchers randomly assigned 303 patients with stage IIIB or IV, ALK-positive NSCLC to receive alectinib or crizotinib. The patients had not received prior systemic therapy for advanced NSCLC.

The findings showed that alectinib reduced the risk of cancer progression or death by 53% compared with crizotinib. Based on independent review, alectinib extended the median time to progression by approximately 15 months (median progression-free survival was 25.7 months with alectinib and 10.4 months with crizotinib). At 12 months, the incidence of brain metastases was much lower with alectinib than with crizotinib (9% vs 41%, respectively).

Overall, severe adverse effects were less common with alectinib than with crizotinib, occurring in 41% vs 50% of patients, respectively.


1. Shaw AT, Peters S, Mok T, Shirish M, et al. Alectinib versus crizotinib in treatment-naive advanced ALK-positive non-small cell lung cancer (NSCLC): primary results of the global phase III ALEX study. J Clin Oncol. 2017;35(suppl):abstr LBA9008.