Acalabrutinib Shows Promise in Relapsed/Refractory Mantle Cell Lymphoma
The Bruton tyrosine kinase inhibitor acalabrutinib (Calquence) was recently approved in the United States for adults with relapsed or refractory mantle cell lymphoma (MCL). In ACE-LY-004, a single-arm, open-label phase 2 trial, 124 patients received oral acalabrutinib 100 mg twice daily until disease progression or unacceptable toxicity. At median follow-up of 15 months, the overall response rate was 81%, which included a complete response rate of 40%. Although median duration of progression-free survival and overall survival were not reached at data cut-off, the 12-month rates were 67% (95% CI, 58%-75%) and 87% (95% CI, 79%-92%), respectively. Median duration of treatment was 13.8 months. The most common grade 3 or higher adverse events were neutropenia (10%), anemia (9%), and pneumonia (5%).
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Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2.