Chronic Lymphocytic Leukemia Coverage from Every Angle

EHA25 Virtual: Long-Term Results With Acalabrutinib in Treatment-Naive CLL

By: Sarah Campen, PharmD
Posted: Monday, June 22, 2020

Mature results from phase II ACE-CL-001 trial continue to support the use of the Bruton’s tyrosine kinase inhibitor acalabrutinib in treatment-naive and relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients who declined or were not eligible for standard chemotherapy. Presented during the virtual edition of the 25th European Hematology Association (EHA) Annual Congress (EHA25 Virtual, Abstract S163), these recent findings show durable responses with no new long-term safety issues, according to John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, Columbus, and colleagues.

Patients with treatment-naive, symptomatic CLL and SLL were eligible for the study if they had an Eastern Cooperative Oncology Group performance status of 0 to 2 and were inappropriate for, or declined, standard chemotherapy. A total of 99 patients received either acalabrutinib at 100 mg twice daily (n = 62) or 200 mg once daily (n = 37)—later switching to 100 mg twice daily—until disease progression or unacceptable toxicity.

At a median follow-up of 53 months, 86% of patients remained on acalabrutinib; progressive disease (n = 3) and adverse events (n = 6) were responsible for most treatment discontinuations. The overall response rate was 97%—with 7% complete responses and 90% partial responses—and the median time to response was 3.7 months. Response rates were similar across high-risk groups.

As for safety, the most common adverse events included diarrhea (52%), headache (45%), upper respiratory tract infection (44%), arthralgia (42%), and contusion (42%). Serious adverse events were reported in 38% of patients, including pneumonia and sepsis.

“Long-term data from ACE-CL-001 further support the favorable results with acalabrutinib in phase III studies,” concluded Dr. Byrd and colleagues.

Disclosure: The study authors’ disclosure information may be found at

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