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Frontline acalabrutinib, lenalidomide and rituximab for advanced stage follicular lymphoma with high tumor burden: phase II trial

P. Strati,Lei Feng,J. Westin,R. Nair,L. Fayad,M. Rodriguez,D. Chihara,L. Malpica,J. Henderson,M. Gallardo,M. Rivera,Iris Wang,Anastasiia A. Bolshakova,A. Radko,D. Kurtz,S. Alig,C. Flowers,A. Alizadeh,S. Neelapu

Published 2025 in Nature Communications

ABSTRACT

This phase II trial aims to determine the efficacy and safety of frontline acalabrutinib, lenalidomide and rituximab for patients with advanced stage follicular lymphoma (FL) and high tumor burden. The primary endpoint was best complete response (CR) rate; the secondary endpoints were overall response rate (ORR), duration of response measured as CR at 30 months (CR30), progression of disease at 24 months (POD24) rate, progression-free survival (PFS), overall survival and safety. Twenty-four patients with previously untreated FL were included in this phase 2 single arm study (NCT04404088). The most common grade 3-4 adverse events were neutropenia (58%) and liver function test elevation (17%). Best ORR was 100% and best CR rate was 92%. CR30 rate was 65% and POD24 rate was 17%. After a median follow-up of 43 months, median PFS and OS were not reached, 2-year PFS rate was 79% and 2-year OS rate was 92%. Here we show that the addition of acalabrutinib to R2 is a safe and effective frontline regimen for FL patients, and further exploration in larger clinical trials is needed. Bruton tyrosine kinase (BTK) inhibitors can interrupt the crosstalk between follicular lymphoma FL cells and macrophages thereby inducing downregulation of pro-survival pathways in FL cells. Here this group reports a phase 2 single-arm trial evaluating the regimen of acalabrutinib with lenalidomide plus rituximab on twenty four patients with previously untreated FL.

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