OT03 | BGB‐11417‐302, A PHASE 3, RANDOMIZED, DOUBLE‐BLIND STUDY OF SONROTOCLAX (BGB‐11417) + ZANUBRUTINIB VERSUS PLACEBO + ZANUBRUTINIB IN RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA

作者：M. Dreyling, Marc A. Hughes, Toby A. Eyre, Yuqin Song, Yanan Wang, Junhua Zhang, H. Alalade, Elena Maksimova, Xinyu Li, Zhiheng Xu, Chi Ho To, Limei Wang · 发表于：Hematological Oncology · 年份：2025 · DOI：10.1002/hon.70093_ot03 · 被引用次数：4 · 研究领域：Chronic Lymphocytic Leukemia Research、Lymphoma Diagnosis and Treatment、Cutaneous lymphoproliferative disorders research

Introduction: Mantle cell lymphoma (MCL) is an uncommon subtype of B-cell non-Hodgkin lymphoma that is typically aggressive. Despite treatment with approved therapies, most patients with MCL experience relapsed or refractory disease and require novel therapy options. Inhibition of B-cell lymphoma 2 (BCL2) and Bruton tyrosine kinase (BTK) with venetoclax + ibrutinib, respectively, has demonstrated efficacy in patients with relapsed or refractory MCL; however, use of this regimen can be limited by toxicity and development of treatment resistance. Sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, is a more selective and pharmacologically potent inhibitor of BCL2 than venetoclax. Zanubrutinib, a next-generation covalent BTK inhibitor, is approved as monotherapy for relapsed or refractory MCL in the US and China. In an ongoing phase 1 trial (NCT04277637), combination treatment with sonrotoclax + zanubrutinib has been generally well tolerated and has shown anti-lymphoma activity in patients with relapsed or refractory MCL. Based on these encouraging results, additional studies to evaluate sonrotoclax + zanubrutinib combination therapy in patients with relapsed or refractory MCL have been designed. Here, an ongoing phase 3 study that will compare the efficacy and safety of sonrotoclax + zanubrutinib versus sonrotoclax-matched placebo + zanubrutinib in adult patients with previously treated, BTK inhibitor–naive/intolerant, relapsed or refractory MCL is described. Methods: BG...