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.۱
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.
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%).