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The B-cell receptor signaling pathway is integral to the pathogenesis of most B-cell malignancies, including chronic lymphocytic leukemia (CLL). One potential target in that pathway is Bruton tyrosine kinase (BTK). Acalabrutinib (ACP-196), an irreversible BTK inhibitor, lacks much of the “off-target” binding of the first-in-class agent, ibrutinib.
Investigators conducted a manufacturer-funded, uncontrolled trial of oral acalabrutinib in 61 patients (median age, 62 years) with relapsed or refractory CLL (median of three previous CLL treatments). Once-daily dose escalation (100–400 mg; phase I) was followed by an expansion (phase II) using 100 mg twice daily.
All but one patient experienced a rapid decrease in lymphadenopathy; most patients (61…