Purpose: Marginal zone lymphoma (MZL) is an uncommon non–Hodgkin lymphoma with malignant cells that exhibit a consistent dependency on B-cell receptor signaling. We evaluated the efficacy and safety of zanubrutinib, a next-generation selective Bruton tyrosine kinase inhibitor, in patients with relapsed/refractory (R/R) MZL. Patients and Methods: Patients with R/R MZL were enrolled in the phase II MAGNOLIA (BGB-3111–214) study. The primary endpoint was overall response rate (ORR) as determined by an independent review committee (IRC) based on the Lugano 2014 classification. Results: Sixty-eight patients were enrolled. After a median follow-up of 15.7 months (range, 1.6 to 21.9 months), the IRC-assessed ORR was 68.2% and complete response (CR) was 25.8%. The ORR by investigator assessment was 74.2%, and the CR rate was 25.8%. The median duration of response (DOR) and median progression-free survival (PFS) by independent review was not reached. The IRC-assessed DOR rate at 12 months was 93.0%, and IRC-assessed PFS rate was 82.5% at both 12 and 15 months. Treatment was well tolerated with the majority of adverse events (AE) being grade 1 or 2. The most common AEs were diarrhea (22.1%), contusion (20.6%), and constipation (14.7%). Atrial fibrillation/flutter was reported in 2 patients; 1 patient had grade 3 hypertension. No patient experienced major hemorrhage. In total, 4 patients discontinued treatment due to AEs, none of which were considered treatment-related by the investigators. Conclusions: Zanubrutinib demonstrated high ORR and CR rate with durable disease control and a favorable safety profile in patients with R/R MZL. This article is featured in Highlights of This Issue, [p. 6279][1] [1]: /lookup/volpage/27/6279?iss=23

中文翻译：

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MAGNOLIA 试验：新一代布鲁顿酪氨酸激酶抑制剂 Zanubrutinib 在复发/难治性边缘区淋巴瘤中显示出安全性和有效性

目的：边缘区淋巴瘤 (MZL) 是一种罕见的非霍奇金淋巴瘤，其恶性细胞表现出对 B 细胞受体信号传导的一致依赖性。我们评估了下一代选择性布鲁顿酪氨酸激酶抑制剂 zanubrutinib 在复发/难治性 (R/R) MZL 患者中的疗效和安全性。患者和方法：R/R MZL 患者被纳入 II 期 MAGNOLIA (BGB-3111–214) 研究。主要终点是由独立审查委员会 (IRC) 根据 Lugano 2014 分类确定的总体缓解率 (ORR)。结果：68 名患者入组。中位随访 15.7 个月（范围 1.6 至 21.9 个月）后，IRC 评估的 ORR 为 68.2%，完全缓解 (CR) 为 25.8%。研究者评估的 ORR 为 74.2%，CR 率为 25.8%。独立审查未达到中位反应持续时间 (DOR) 和中位无进展生存期 (PFS)。IRC 评估的 12 个月 DOR 率为 93.0%，IRC 评估的 PFS 率为 12 个月和 15 个月时的 82.5%。治疗耐受性良好，大多数不良事件 (AE) 为 1 级或 2 级。最常见的 AE 为腹泻 (22.1%)、挫伤 (20.6%) 和便秘 (14.7%)。2 例患者报告心房颤动/扑动；1 例患者有 3 级高血压。没有患者出现大出血。总共有 4 名患者因 AE 停止治疗，研究人员认为没有一例与治疗相关。结论：Zanubrutinib 在 R/R MZL 患者中表现出高 ORR 和 CR 率以及持久的疾病控制和良好的安全性。这篇文章刊登在本期要闻中，[p。6279][1] [1]: /lookup/volpage/27/6279?iss=23