Key clinical point: Acalabrutinib demonstrates favorable long-term efficacy and safety in patients with relapsed or refractory mantle cell lymphoma (MCL), including those with poor prognostic factors.
Major finding: The overall and complete response rates were 81.5% (95% CI 73.5%-87.9%) and 47.6% (95% CI 38.5%-56.7%), respectively. After a 38.1-month median follow-up, median duration of response and progression-free survival were 28.6 (95% CI 17.5-39.1) and 22.0 (95% CI 16.6-33.3) months, respectively. No new safety signals were observed.
Study details: The data represent the final results of the phase 2 ACE-LY-004 study of 124 adult patients with MCL, including those with poor prognostic factors, such as blastoid or pleomorphic morphology and Ki-67 index of >30%, who relapsed after or were refractory to ≤ 5 previous therapies and received acalabrutinib twice daily.
Disclosures: This study was funded by AstraZeneca. Some authors declared serving as consultants, advisors, or speakers for and receiving research funds or travel or accommodation expenses from various sources, including AstraZeneca. Two authors declared being employees or equity holders of AstraZeneca.
Source: Le Gouill S et al. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors. Haematologica. 2023 (Jul 20). doi: 10.3324/haematol.2022.282469