TY - JOUR
T1 - Zanubrutinib monotherapy in relapsed/refractory mantle cell lymphoma
T2 - a pooled analysis of two clinical trials
AU - Zhou, Keshu
AU - Zou, Dehui
AU - Zhou, Jianfeng
AU - Hu, Jianda
AU - Yang, Haiyan
AU - Zhang, Huilai
AU - Ji, Jie
AU - Xu, Wei
AU - Jin, Jie
AU - Lv, Fangfang
AU - Feng, Ru
AU - Gao, Sujun
AU - Zhou, Daobin
AU - Tam, Constantine S.
AU - Simpson, David
AU - Wang, Michael
AU - Phillips, Tycel J.
AU - Opat, Stephen
AU - Huang, Zhiyue
AU - Lu, Huafei
AU - Song, Yuqin
AU - Song, Yongping
N1 - Funding Information:
This study was sponsored by BeiGene.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/10/14
Y1 - 2021/10/14
N2 - Mantle cell lymphoma (MCL) is a mature B-cell neoplasm with a high initial response rate followed almost invariably by relapse. Here we report the pooled data from 2 studies, BGB-3111-AU-003 and BGB-3111-206, to explore the efficacy of zanubrutinib monotherapy in relapsed/refractory (R/R) MCL. A total of 112 patients were included. Median follow-up durations were 24.7 and 24.9 months for BGB-3111-AU-003 and BGB-3111-206, respectively. Overall response rate (ORR) and complete response (CR) rate were 84.8% and 62.5%, and median duration of response, progression-free survival (PFS) and overall survival (OS) were 24.9, 25.8 and 38.2 months, respectively. After weighting, the PFS (median: NE vs. 21.1 months, P = 0.235) and OS (median: NE vs. 38.2 months, P = 0.057) were similar but numerically better in the second-line than later-line group. Zanubrutinib was well-tolerated with treatment discontinuation and dose reduction for adverse events in 12.5% and 2.7% of patients, respectively. Hypertension, major hemorrhage and atrial fibrillation/flutter rates were 11.6%, 5.4% and 1.8%, respectively. Zanubrutinib is efficacious in R/R MCL, with a favorable safety profile.
AB - Mantle cell lymphoma (MCL) is a mature B-cell neoplasm with a high initial response rate followed almost invariably by relapse. Here we report the pooled data from 2 studies, BGB-3111-AU-003 and BGB-3111-206, to explore the efficacy of zanubrutinib monotherapy in relapsed/refractory (R/R) MCL. A total of 112 patients were included. Median follow-up durations were 24.7 and 24.9 months for BGB-3111-AU-003 and BGB-3111-206, respectively. Overall response rate (ORR) and complete response (CR) rate were 84.8% and 62.5%, and median duration of response, progression-free survival (PFS) and overall survival (OS) were 24.9, 25.8 and 38.2 months, respectively. After weighting, the PFS (median: NE vs. 21.1 months, P = 0.235) and OS (median: NE vs. 38.2 months, P = 0.057) were similar but numerically better in the second-line than later-line group. Zanubrutinib was well-tolerated with treatment discontinuation and dose reduction for adverse events in 12.5% and 2.7% of patients, respectively. Hypertension, major hemorrhage and atrial fibrillation/flutter rates were 11.6%, 5.4% and 1.8%, respectively. Zanubrutinib is efficacious in R/R MCL, with a favorable safety profile.
KW - Complete response rate
KW - Mantle cell lymphoma
KW - Progression-free survival
KW - Second-line therapy
KW - Zanubrutinib
UR - http://www.scopus.com/inward/record.url?scp=85117339844&partnerID=8YFLogxK
U2 - 10.1186/s13045-021-01174-3
DO - 10.1186/s13045-021-01174-3
M3 - Letter
C2 - 34649571
AN - SCOPUS:85117339844
SN - 1756-8722
VL - 14
JO - Journal of Hematology & Oncology
JF - Journal of Hematology & Oncology
IS - 1
M1 - 167
ER -
