Safety and efficacy of zanubrutinib in relapsed/refractory marginal zone lymphoma: final analysis of the MAGNOLIA study

Stephen Opat, Alessandra Tedeschi, Bei Hu, Kim M. Linton, Pamela McKay, Sophie Leitch, Morton Coleman, Pier Luigi Zinzani, Jie Jin, Mingyuan Sun, Magdalena Sobieraj-Teague, Peter Browett, Xiaoyan Ke, Catherine Thieblemont, Kirit Ardeshna, Fontanet Bijou, Patricia Walker, Eliza A. Hawkes, Shir Jing Ho, Keshu ZhouZhiyu Liang, Jianfeng Xu, Chris Tankersley, Richard Delarue, Melannie Co, Judith Trotman

Research output: Contribution to journalArticlepeer-review

Abstract

The primary analysis of MAGNOLIA, an open-label, single-arm, multicenter, phase 2 study, demonstrated that the next-generation Bruton tyrosine kinase (BTK) inhibitor zanubrutinib provided a high overall response rate (ORR) in patients with relapsed/refractory marginal zone lymphoma (R/R MZL), with a favorable safety/tolerability profile. Presented here, is the final analysis of MAGNOLIA, performed to characterize the durability of response and longer-term safety and tolerability. Zanubrutinib (160 mg twice daily) was evaluated in 68 patients with R/R MZL who had received at least 1 anti-CD20–directed regimen. The primary end point was independent review committee (IRC)-assessed ORR. Secondary end points included investigator-assessed ORR, duration of response (DOR), progression-free survival (PFS), overall survival (OS), health-related quality of life, safety, and tolerability. With a median follow-up of 27.4 months, the IRC-assessed ORR was 68.2% (95% confidence interval [CI], 55.6-79.1), with a 24-month DOR event-free rate of 72.9% (95% CI, 54.4-84.9). PFS and OS at 24 months were 70.9% (95% CI, 57.2-81.0) and 85.9% (95% CI, 74.7-92.4), respectively. The zanubrutinib safety profile was consistent with the primary analysis, with no new safety signals observed. Atrial fibrillation/flutter (n = 2 [2.9%]) and hypertension (n = 3 [4.4%]) were uncommon. Neutropenia (n = 8 [11.8%]) was the most common grade ≥3 adverse event. In this final analysis of MAGNOLIA, zanubrutinib demonstrated sustained clinical responses beyond 2 years, with 73% of responders alive and progression free. Zanubrutinib continued to demonstrate a favorable safety/tolerability profile with the additional time on treatment.

Original languageEnglish
Pages (from-to)6801-6811
Number of pages11
JournalBlood Advances
Volume7
Issue number22
DOIs
Publication statusPublished - 2023

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