NICE recommends lorlatinib for metastatic ALK-positive NSCLC

  • National Institute for Health and Care Excellence

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • The National Institutes for Health and Care Excellence (NICE) has recommended lorlatinib (Pfizer) as first-line treatment for previously treated anaplastic lymphoma kinase (ALK)-positive advanced NSCLC.
  • The recommendation is for patients experiencing disease progression after treatment with alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) or crizotinib and at least 1 other ALK TKI.

Why this matters

  • There is no cure for metastatic ALK-positive NSCLC, leaving an unmet treatment need.

Key points

  • Indirect analyses comparing lorlatinib with platinum doublet chemotherapy (PDC) or atezolizumab with bevacizumab, carboplatin, and paclitaxel (ABCP) suggest that patients who receive lorlatinib have longer PFS and may have better OS than those who receive PDC or ABCP.
  • The recommendation is based on a single-group, open-label, international, multicenter phase 1/2 trial in 139 adults with metastatic ALK-positive NSCLC:
    • Objective response rate: 40.3% (95% CI, 32.1%-48.9%) with lorlatinib.
    • PFS: 6.9 (95% CI, 5.4-8.2) months.
    • Median OS: 20.4 months (95% CI, 16.1 months-not reached).
  • More than 50% of patients with ALK-positive NSCLC develop brain metastases, and lorlatinib can penetrate the blood-brain barrier.
  • Lorlatinib is recommended only if the manufacturer provides the drug according to the commercial arrangement, which makes it available to the National Health Service with a discount.