The following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

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 (ClinicalTrials.gov 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).

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.”

Read more of Cancer Therapy Advisor‘s coverage of the American Society of Hematology (ASH) 2017 meeting by visiting the conference page.

Reference

  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.