Pooled analysis of safety data from clinical trials evaluating acalabrutinib monotherapy in mature B-cell malignancies

BTK inhibition is an effective therapy for many B-cell malignancies. Acalabrutinib is a next-generation, potent, highly selective, covalent BTK inhibitor. Pooled analysis of safety data from nine clinical trials (1040 patients) evaluating acalabrutinib monotherapy for mature B-cell malignancies found that serious adverse events occurred in 39% of patients; pneumonia (6%) was the only SAE that occurred in more than 2%. Fatal AEs occurred in 5%, and AEs leading to treatment discontinuation in 9%. The authors conclude that the analysis confirms acalabrutinib’s tolerability and supports acalabrutinib as long-term treatment for mature B-cell malignancies.