Acalabrutinib monotherapy yields high and durable overall response (ORR) and complete response (CR) rates among patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), according to findings presented at the American Society of Hematology (ASH) 59th Annual Meeting & Exposition in Atlanta, Georgia.1

Previous studies demonstrated that patients with MCL respond well to ibrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor. Acalabrutinib is a highly selective and potent inhibitor of BTK.

For the phase 2 ACE-LY-004 study ( Identifier: NCT02213926), researchers enrolled 124 patients with R/R MCL to receive acalabrutinib 100 mg twice daily.

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At the time of analysis, the median time on study was 15.2 months. The investigator-assessed ORR was 81% (95% CI, 73-87%) with 40% (95% CI, 31-49%) of patients having a CR. The ORR and CR rate were consistent across all pre-specified subgroups (age, tumor bulk of 10 cm or greater, and number/type of prior treatments).

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The median time to response (TRR) was 1.9 months. The median duration of response (DoR) was not reached, though the 12-month DoR rate was 72% (95% CI, 62-80%).

Median progression-free survival (PFS) and overall survival (OS) were not reached, though the 12-month PFS rate was 67% (95% CI, 58-75%) and the 12-month OS rate was 87% (95% CI, 79-92%).

The most frequently reported grade 1 to 2 adverse events (AE) included headache, diarrhea, fatigue, myalgia, cough, nausea, and pyrexia. Grade 3 to 4 AEs included neutropenia, anemia, and pneumonia.

The study’s presenter concluded that acalabrutinib “demonstrated compelling efficacy and a differentiated safety profile, thus providing an alternative therapeutic option for patients with R/R MCL.”


  1. Wang M, Rule S, Zinzani PL, et al. Efficacy and safety of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma in the phase 2 ACE-LY-004 study. Oral presentation at: American Society of Hematology (ASH) 59th Annual Meeting & Exposition; December 9-12, 2016; Atlanta, GA.

This article originally appeared on Cancer Therapy Advisor