Alectinib showed clinical activity and was well tolerated in patients with anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC) who had progressed on crizotinib, a study published in The Lancet Oncology has shown.1

For the single-arm, multicenter, phase 2 study, researchers enrolled 87 patients with stage 3b to 4, ALK-positive NSCLC who had progressed after crizotinib. Patients received alectinib 600 mg orally twice daily until disease progression, withdrawal, or death.

Results showed that at a median follow-up of 4.8 months, the objective response rate was 48% (95% CI, 36 – 60) as assessed by an independent review committee.

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In terms of safety, the most common grade 1 to 2 adverse events were constipation, fatigue, myalgia, and peripheral edema. The most frequent grade 3 and 4 adverse events were laboratory value changes, such as increased creatinine phosphokinase, increased alanine aminotransferase, and increased aspartate aminotransferase. Two patients died while on treatment, of which 1 was caused by a hemorrhage related to alectinib.

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The findings suggest that alectinib could be a suitable treatment for patients with ALK-positive disease who have progressed on crizotinib and were the part of the basis for approval by the U.S. Food and Drug Administration (FDA).

Alectinib is a highly selective, CNS-active, kinase inhibitor recently approved by the FDA for the treatment of patients with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib.


  1. Shaw AT, Gandhi L, Gadgeel S, et al. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial [published online ahead of print December 18, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)-00488-X.