Dr. Furman on the Safety of Acalabrutinib in Hematologic Malignancies

Richard R. Furman, MD, a member of the Lymphoma/Myeloma Service in the Division of Hematology/Oncology and director of the CLL Research Center at Weill Cornell Medical College, and attending physician at New York-Presbyterian Hospital, discusses the safety of acalabrutinib (Calquence) as a monotherapy in hematologic malignancies.

Results from a pooled analysis, which spans across several hematologic malignancies, showed that the second-generation BTK inhibitor demonstrated favorable long-term tolerability in patients with B-cell malignancies. This analysis included 1040 patients, a large number of whom had chronic lymphocytic leukemia (CLL). The study also included a large number of patients with multiple myeloma and aggressive lymphoma, all of whom experienced very different adverse events (AEs).

Most of those AEs are likely tumor-related, not drug related, says Furman. This was a heterogeneous population that included patients who were sicker than what might be expected in just the CLL population, as well as populations of patients where acalabrutinib is not as efficacious as it is in CLL. Many AEs were unrelated to the drug, which makes the agent's profile look “messier,” says Furman.

It is important to keep that in mind when looking at these data compared with what might be expected from a pure CLL population, explains Furman. In this study, investigators pooled patients who received single-agent acalabrutinib on 9 different studies to look at the aggregated data. The median follow-up was approximately 52 months and results showed that acalabrutinib was well tolerated. Investigators reported that the tolerability that was seen early on with acalabrutinib monotherapy was maintained with longer follow-up, concludes Furman.