Safety and Efficacy of Rocbrutinib in Patients with Relapsed/Refractory Marginal Zone Lymphoma

作者：Yuqin Song, Qingqing Cai, Keshu Zhou, Ming Jiang, Zhengming Jin, Lei Zhang, Xiuhua Sun, Haiyan Yang, Lanfang Li, Kaiyang Ding, Junyuan Qi, Hongmei Jing, Wei Yang, Min Zhou, Jun Ma, Zhigang Peng, Wei Xu, Hui Zhou, Yu Li, Yuankai Shi, Guohui Cui, Zheng Wang, Nawei Liu, Yejiang Lou, Yue Shen, Yi Chen, Fenlai Tan, Jun Zhu · 发表于：Blood · 年份：2024 · DOI：10.1182/blood-2024-194572 · 被引用次数：2 · 研究领域：Chronic Lymphocytic Leukemia Research、Lymphoma Diagnosis and Treatment、Viral-associated cancers and disorders

Background: Marginal zone lymphoma (MZL) comprises approximately 8% to 12% of non-Hodgkin lymphomas (NHL), characterized by malignant cells that consistently rely on B-cell receptor signaling. Covalent Bruton's tyrosine kinase inhibitors (cBTKis) have shown activity in relapsed or refractory (R/R) MZL, achieving an overall response rate (ORR) of 40-60%. Rocbrutinib, a new-generation BTKi, is highly selective with excellent bioavailability and a unique dual binding mechanism: covalent binding, otherwise non-covalent with C481 mutation. Here, we present the efficacy and safety outcomes of rocbrutinib in patients with R/R MZL enrolled in an ongoing phase 1 study (NCT04993690) in B-cell malignancies. Methods: Patients with R/R MZL who received ≥1 line of prior therapies, including an anti-CD20 antibody-containing regimen, were enrolled. Adverse events (AEs) were graded per CTCAE v5.0 and disease responses were assessed per Lugano 2014 response criteria. Results: Between 30 July 2021 and 31 May 2024, 30 R/R MZL patients were enrolled and received treatment of rocbrutinib at 100mg (n=3), 150mg (n=21) and 200mg (n=6) QD respectively, till disease progression or unacceptable toxicities. The median age was 65 (range, 32 to 79) years. 22 were with extra-nodal MZL (73.3%), and 5 nodal MZL (16.7%). Most patients (90%) were with advanced-stage disease; 46.7% had intermediate to high-risk disease per International Prognostic Index (IPI). All 30 patients received at least one prior line of ...