What is the role of alectinib in the treatment of non–small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
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Answer

In November 2017, the FDA approved alectinib (Alecensa), a TKI that targets ALK and RET, for the frontline treatment of patients with ALK-positive metastatic NSCLC. In addition to granting this new indication, the FDA also converted alectinib’s indication for patients with ALK-positive NSCLC who have progressed on crizotinib from accelerated approval to full approval. Alectinib is indicated for ALK-positive, metastatic NSCLC in patients whose disease has progressed on crizotinib or who are intolerant to crizotinib.

Approval was primarily based on findings from the phase III ALEX study. In the trial, treatment-naïve patients were randomly assigned to alectinib 600 mg PO BID or crizotinib 250 mg PO BID. Median PFS, as determined by an independent review committee, was 25.7 months in the alectinib arm versus 10.4 months in the crizotinib arm. The ORR with alectinib was 79% versus 72% with crizotinib. The complete response rates were 13% versus 6%, respectively, and the partial response rate was 66% in both arms. Eighty-two percent of patients receiving alectinib had a response duration ≥6 months, with 64% and 37%, having response durations ≥12 months and ≥18 months, respectively. The corresponding rates in the crizotinib arm were 57%, 36%, and 14%. [186]


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