CLL: acalabrutinib offers high response rate in ibrutinib-intolerant patients

  • Awan FT & al.
  • Blood Adv
  • 14 May 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Acalabrutinib, a novel Bruton tyrosine kinase inhibitor, demonstrated high-level tolerability and response in patients with chronic lymphocytic leukemia (CLL) who were intolerant to ibrutinib.

Why this matters

  • Ibrutinib has demonstrated excellent efficacy in this setting; however, 9%-23% of patients experience treatment-limiting adverse effects.

Study design

  • Study to investigate acalabrutinib monotherapy in 33 ibrutinib-intolerant patients with CLL.
  • 64 (range, 50-82) years median patient age.
  • Many patients had high-risk disease.
  • Patients had received a median of 4 (range, 2-13) prior therapies.
  • Funding: National Cancer Institute, National Institutes of Health, Acerta Pharma.

Key results

  • 75.8% (95% CI, 57.7%-88.9%) overall response rate (ORR; defined as partial response with lymphocytosis or better [≥PRL]).
  • 3.0% complete remission.
  • All patients achieved at least stable disease.
  • 1.9 (range, 1.6-19.2) months median time to ≥PRL.
  • Median duration of response (DOR) was not reached.
  • 82% (95% CI, 59%-93%) had DOR of ≥12 months.
  • 70% of patients remained on acalabrutinib at a median of 19.0 (range, 0.7-30.6) months.
  • No patients required acalabrutinib dose reductions.
  • Grade ≥3 adverse events (AEs) occurring in >3% of patients included neutropenia (12%) and thrombocytopenia (9%).
  • Only 3 patients discontinued acalabrutinib due to AEs.

Limitations

  • Limited sample size.

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