Zanubrutinib monotherapy in relapsed/refractory mantle cell lymphoma: a pooled analysis of two clinical trials

J Hematol Oncol. 2021 Oct 14;14(1):167. doi: 10.1186/s13045-021-01174-3.


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.

Keywords: Complete response rate; Mantle cell lymphoma; Progression-free survival; Second-line therapy; Zanubrutinib.

Publication types

  • Clinical Trial
  • Letter
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Agents / therapeutic use*
  • Female
  • Humans
  • Lymphoma, Mantle-Cell / drug therapy*
  • Male
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Piperidines / therapeutic use*
  • Pyrazoles / therapeutic use*
  • Pyrimidines / therapeutic use*
  • Survival Analysis


  • Antineoplastic Agents
  • Piperidines
  • Pyrazoles
  • Pyrimidines
  • zanubrutinib