Zanubrutinib monotherapy in relapsed/refractory indolent non-Hodgkin lymphoma
- Author(s)
- Phillips, T; Chan, H; Tam, CS; Tedeschi, A; Johnston, P; Oh, SY; Opat, S; Eom, HS; Allewelt, H; Stern, JC; Tan, Z; Novotny, W; Huang, J; Trotman, J;
- Details
- Publication Year 2022-06-14,Volume 6,Issue #11,Page 3472-3479
- Journal Title
- Blood Advances
- Publication Type
- Research article
- Abstract
- Outcomes for marginal zone lymphoma (MZL) and follicular lymphoma (FL) remain suboptimal, owing to the limited number of approved agents and the incurable nature of the diseases. BGB-3111-AU-003 was a phase 1/2, open-label, multicenter, single-agent study of the selective Bruton's tyrosine kinase inhibitor zanubrutinib in 385 patients with B-cell malignancies. Here, we present safety and efficacy outcomes for the 53 enrolled patients with relapsed/refractory MZL (n = 20) and relapsed/refractory FL (n = 33), all of whom were enrolled during the part 2 dose expansion, and therefore received zanubrutinib at the recommended phase 2 dose. Treatment with zanubrutinib was generally well tolerated, with most adverse events being </= grade 2. Atrial fibrillation/flutter was not reported. Two patients required dose reduction, and 4 patients discontinued treatment because of adverse events. Response was assessed by an independent review committee for MZL and the investigators for FL, per Lugano 2014 classification for non-Hodgkin lymphoma. In patients with MZL, the overall response rate (ORR) was 80%, and the complete response (CR) rate was 20%. With median follow-up of 33.8 months, median progression-free survival (PFS) was not reached. In patients with FL, the ORR was 36.4%, and the CR rate was 18.2%. After a median follow-up of 33.9 months, median PFS was 10.4 months. In conclusion, the results of this study suggest a favorable benefit-risk profile and support zanubrutinib as a potentially meaningful addition to available therapies for patients with relapsed/refractory MZL and FL. This trial was registered at www.clinicaltrials.gov as #NCT02343120.
- Keywords
- Humans; *Lymphoma, B-Cell, Marginal Zone/pathology; *Lymphoma, Follicular/drug therapy; Piperidines/adverse effects; Pyrazoles/adverse effects; Pyrimidines/adverse effects
- Department(s)
- Haematology
- PubMed ID
- 35390135
- Publisher's Version
- https://doi.org/10.1182/bloodadvances.2021006083
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2025-02-20 06:41:15
Last Modified: 2025-02-20 06:42:28