Dr Ferrajoli on the Incidence of Hypertension in Patients With CLL Receiving Acalabrutinib

Alessandra Ferrajoli, MD, associate medical director, professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the rationale for, and findings from, a cumulative review of hypertension in patients with chronic lymphocytic leukemia (CLL) and other hematologic malignancies who received acalabrutinib (Calquence).

As the clinical use of BTK inhibitors increases, oncologists are learning more about their activity and unique toxicity profiles, Ferrajoli says. Information on the toxicities associated with these agents can help oncologists choose the optimal BTK inhibitors for individual patients, Ferrajoli explains.

CLL is associated with a high rate of comorbidities, such as cardiovascular disease, of which hypertension is the most common. Previous studies have demonstrated that hypertension can develop or worsen in patients with CLL who receive the BTK inhibitors ibrutinib (Imbruvica) and zanubrutinib (Brukinsa). However, the phase 3 ELEVATE-RR trial (NCT02477696) indicated that the selective, second-generation BTK inhibitor acalabrutinib induced a lower rate of hypertension vs ibrutinib at a median follow-up of 40.9 months in patients with previously treated CLL.

Ferrajoli and coinvestigators determined the incidence of new or worsening hypertension in patients from the acalabrutinib global development program and compared this rate with the prevalence of hypertension in a real-world population of patients with CLL who had yet to initiate treatment. Investigators obtained safety reports of new or worsening hypertension from 11 clinical trials evaluating the efficacy and safety of acalabrutinib monotherapy, including ELEVATE-RR and the phase 3 ELEVATE-TN (NCT02475681) and ASCEND (NCT02970318) trials. Furthermore, ibrutinib hypertension data were obtained from ELEVATE-RR, and hypertension data with other comparator agents were obtained from ELEVATE-TN and ASCEND.

This study confirmed that the prevalence of hypertension in patients with CLL who received acalabrutinib monotherapy across all 11 clinical trials was similar to that in patients with CLL who had not yet received treatment, Ferrajoli concludes.