Final phase 2 study results of acalabrutinib in treatment-naive and relapsed/refractory chronic lymphocytic leukemia - PubMed

6 hours ago

Acalabrutinib is a selective covalent Bruton tyrosine kinase inhibitor approved for chronic lymphocytic leukemia/small lymphocytic lymphoma.
Final phase 1/2 study results included 99 treatment-naive and 134 relapsed/refractory patients, with median follow-ups of 73.7 and 52.6 months.
At final cutoff, 71% of treatment-naive and 31% of relapsed/refractory patients remained on acalabrutinib treatment.
Key adverse events (any grade) included atrial fibrillation (6.1% TN, 9.0% R/R), hypertension (29.3% TN, 23.1% R/R), other malignancies (14.1% TN, 17.2% R/R), and major bleeding (8.1% TN, 8.2% R/R), with incidence decreasing over time.
Overall response rates were 97.0% in treatment-naive and 94.8% in relapsed/refractory cohorts, with similar responses across genomic risk groups.
In treatment-naive patients, median progression-free survival was not reached, and the 72-month rate was 86.7%.
In relapsed/refractory patients, median progression-free survival was 66.1 months, and the 72-month rate was 45.1%.
The analysis confirms long-term efficacy and safety, with no new safety signals and tolerability of acalabrutinib monotherapy in CLL/SLL.

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