Brigatinib

(Alunbrig®)

Alunbrig®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 30 mg, 90 mg, 180 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

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Summary
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  • Alunbrig (brigatinib) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
  • This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-15]
  • Brigatinib showed significant improvement in overall PFS compared to crizotinib (HR: 0.48, 95% CI: 0.35 to 0.66) and ceritinib (HR: 0.38, 95% CI: 0.23 to 0.60) in first-line treatment settings and was comparable to other second-generation ALK inhibitors.
  • Brigatinib demonstrated robust intracranial PFS, with an iPFS of 19.26 months in patients with baseline brain metastases, indicating strong efficacy in treating brain metastases.
  • The overall survival benefit of brigatinib was observed in comparison to crizotinib (HR: 0.50, 95% CI: 0.28 to 0.87), but it showed no significant difference in OS when compared to other next-generation ALK inhibitors.
  • Brigatinib had a pooled ORR of 64% (95% CI 45%-83%) and a DCR of 88% (95% CI 80%-96%), demonstrating superior ORR to crizotinib and being comparable to other next-generation ALK inhibitors.
  • Brigatinib had a higher rate of grade 3-4 adverse events (63.7%) compared to alectinib (16.2%) but lower than lorlatinib (91.6%) and similar to ensartinib and ceritinib.
  • The most frequent adverse events associated with brigatinib included gastrointestinal reactions, hypertension, cough, headache, elevated ALT/AST levels, and increased creatine phosphokinase (CPK).
  • Brigatinib's incidence of serious adverse events was comparable to other next-generation ALK inhibitors except for alectinib, which had a notably lower rate.
  • Brigatinib was particularly effective in patients with baseline brain metastases, showing significant intracranial progression-free survival (iPFS), and demonstrated comparable efficacy in Asian populations, although ensartinib sometimes showed superior efficacy in this subgroup.

Product Monograph / Prescribing Information

Document TitleYearSource
Alunbrig (Brigatinib) Prescribing Information.2022Takeda Pharmaceutical Company Limited, Cambridge, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Identifying optimal ALK inhibitors in first- and second-line treatment of patients with advanced ALK-positive non-small-cell lung cancer: a systematic review and network meta-analysis.2024BMC Cancer
Comparative efficacy of ALK inhibitors for treatment-naïve ALK-positive advanced non-small cell lung cancer with central nervous system metastasis: a network meta-analysis.2023International Journal of Molecular Sciences
Efficacy and safety of first-line treatments for patients with advanced anaplastic lymphoma kinase mutated, non-small cell cancer: a systematic review and network meta-analysis.2023Cancer
Comparative safety of anaplastic lymphoma kinase tyrosine kinase inhibitors in advanced anaplastic lymphoma kinase-mutated non-small cell lung cancer: systematic review and network meta-analysis.2023Lung Cancer
A Bayesian network meta-analysis of ALK inhibitor treatments in patients with ALK-positive non-small cell lung cancer.2023Cancer Medicine
Alectinib for treating patients with metastatic ALK-positive NSCLC: systematic review and network metanalysis.2023Lung Cancer Management
Comparison of efficacy and safety of brigatinib in first-line treatments for patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer: a systematic review and indirect treatment comparison.2022Journal of Clinical Medicine
Targeted therapy for advanced anaplastic lymphoma kinase (ALK)‐rearranged non‐small cell lung cancer.2022The Cochrane Database of Systematic Reviews
Efficacy and safety of brigatinib in ALK-positive non-small cell lung cancer treatment: a systematic review and meta-analysis.2022Frontiers in Oncology
Comparative efficacy and safety of lorlatinib and alectinib for alk-rearrangement positive advanced non-small cell lung cancer in Asian and non-Asian patients: a systematic review and network meta-analysis.2021Cancers
Systematic review and network meta-analysis of anaplastic lymphoma kinase (ALK) inhibitors for treatment-naïve ALK-positive lung cancer.2021Cancers
First-line anaplastic lymphoma kinase (ALK) inhibitors for ALK-positive lung cancer in Asian populations: systematic review and network meta-analysis.2021Journal of Clinical Medicine
Comparative efficacy and safety of first-line treatments for advanced non-small cell lung cancer with ALK-rearranged: a meta-analysis of clinical trials.2021BMC Cancer
Brigatinib and alectinib for ALK rearrangement-positive advanced non-small cell lung cancer with or without central nervous system metastasis: a systematic review and network meta-analysis.2020Cancers
ALK inhibitors for non-small cell lung cancer: a systematic review and network meta-analysis.2020PLoS One

Clinical Practice Guidelines