articleJournal of Clinical OncologyOct 9, 2012BRONZE OA

Bruton Tyrosine Kinase Inhibitor Ibrutinib (PCI-32765) Has Significant Activity in Patients With Relapsed/Refractory B-Cell Malignancies

University of Vermont · The University of Texas MD Anderson Cancer Center · +8 more institutions

PubMed
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Abstract

Results

Fifty-six patients with a variety of B-cell malignancies were treated over seven cohorts. Most adverse events were grade 1 and 2 in severity and self-limited. Dose-limiting events were not observed, even with prolonged dosing. Full occupancy of the BTK active site occurred at 2.5 mg/kg per day, and dose escalation continued to 12.5 mg/kg per day without reaching MTD. Pharmacokinetic data indicated rapid absorption and elimination, yet BTK occupancy was maintained for at least 24 hours, consistent with the irreversible mechanism. Objective response rate in 50 evaluable patients was 60%, including complete response of 16%. Median progression-free survival in all patients was 13.6 months.

Conclusion

Ibrutinib, a novel BTK-targeting inhibitor, is well tolerated, with substantial activity across B-cell histologies.

Citation impact

1,115
total citations
FWCI
57.61
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100%
References
32
Citations per year

Authors

15

Topics & keywords

Keywords
  • Ibrutinib
  • Bruton's tyrosine kinase
  • Medicine
  • Dosing
  • Chronic lymphocytic leukemia
  • Pharmacology
  • Tyrosine-kinase inhibitor
  • Internal medicine
UN Sustainable Development Goals
  • Good health and well-being
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Funding