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

Updated: Aug 21, 2019
  • Author: Maurie Markman, MD, MS; Chief Editor: Keith K Vaux, MD  more...
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Answer

Answer

In November 2017, the FDA approved alectinib (Alecensa) for the frontline treatment of patients with ALK-positive metastatic NSCLC, a TKI that targets ALK and RET. In addition to granting this new indication, the FDA has also converted alectinib’s accelerated approval for patients with ALK-positive NSCLC who have progressed on crizotinib to a full approval. It is indicated for anaplastic lymphoma kinase (ALK)-positive, metastatic NSCLC in patients whose disease has progressed on crizotinib or who are intolerant to crizotinib. The NCCN guidelines lists alectinib as the preferred first-line treatment in ALK-positive metastatic NSCLC. [1]

Approval was primarily based on findings from the phase III ALEX study. In the trial, treatment-naive 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 overall response rate (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%. [36]


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