Zanubrutinib Versus Bendamustine and Rituximab in Patients With Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Median 5-Year Follow-Up of SEQUOIA

作者：Mazyar Shadman, Talha Munir, Tadeusz Robak, Jennifer R. Brown, Brad S. Kahl, Paolo Ghia, Krzysztof Giannopoulos, Martin Šimkovič, Anders Österborg, Luca Laurenti, Patricia Walker, Stephen Opat, Hanna Ciepłuch, Richard Greil, Merit Hanna, Monica Tani, Marek Trněný, Danielle M. Brander, Ian W. Flinn, Sebastian Grosicki, Emma Verner, Alessandra Tedeschi, Sophie de Guibert, Gayane Tumyan, Kamel Laribi, José A. García-Marco, Jianyong Li, Tian Tian, Yu Liu, Roman Korolkiewicz, Andy H. Szeto, Constantine S. Tam, Wojciech Jurczak · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco-24-02265 · 被引用次数：60 · 研究领域：Chronic Lymphocytic Leukemia Research、Lymphoma Diagnosis and Treatment、Gastrointestinal Tumor Research and Treatment

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. SEQUOIA (ClinicalTrials.gov identifier: NCT03336333 ) is a phase III, randomized, open-label trial that compared the oral Bruton tyrosine kinase inhibitor zanubrutinib to bendamustine plus rituximab (BR) in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The initial prespecified analysis (median follow-up, 26.2 months) and subsequent analysis (43.7 months) found superior progression-free survival (PFS; the primary end point) in patients who received zanubrutinib compared with BR. At a median follow-up of 61.2 months, median PFS was not reached in zanubrutinib-treated patients; median PFS was 44.1 months in BR-treated patients (hazard ratio [HR], 0.29; one-sided P = .0001). Prolonged PFS was seen with zanubrutinib versus BR in patients with mutated immunoglobulin heavy-chain variable region (IGHV) genes (HR, 0.40; one-sided P = .0003) and unmutated IGHV genes (HR, 0.21 [95% CI, 0.14 to 0.33]; one-sided P < .0001). Median overall survival (OS) was not reached in either treatment arm; estimated 60-month OS rates ...