SEQUOIA 5-year follow-up in arm C: Frontline zanubrutinib monotherapy in patients with del(17p) and treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

作者：Constantine S. Tam, Paolo Ghia, Mazyar Shadman, Talha Munir, Stephen Opat, Patricia Walker, Masa Lasica, Ian W. Flinn, Tian Tian, Stephanie Agresti, Jamie Hirata, Jennifer R. Brown · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.7011 · 被引用次数：5 · 研究领域：Chronic Lymphocytic Leukemia Research、Chronic Myeloid Leukemia Treatments、Lymphoma Diagnosis and Treatment

7011 Background: Zanubrutinib (zanu) is a next-generation Bruton tyrosine kinase inhibitor that is approved for 5 indications, including CLL/SLL. Initial results from the SEQUOIA study (NCT03336333), at a median follow-up of 26.2 mo, demonstrated superior progression-free survival (PFS) by independent review with zanu vs bendamustine + rituximab (arms A and B) in patients (pts) with treatment-naive (TN) CLL/SLL without del(17p) as well as high overall response rate (ORR) and PFS benefit in pts with del(17p) (arm C). Additionally, the 5-y follow-up in arm A demonstrated durable PFS benefit, with estimated 54- and 60-mo PFS rates of 80% and 76%, respectively. Here we report updated results in SEQUOIA arm C, in pts with del(17p), after approximately 5 y of follow-up (data cutoff: Apr 30, 2024). Methods: Arm C is a nonrandomized cohort of SEQUOIA pts with del(17p) that received zanu monotherapy. Investigator-assessed PFS, overall survival (OS), ORR, and safety/tolerability were evaluated. Adverse events (AEs) were recorded until disease progression or start of next-line therapy. Results: Between Feb 2018 and Mar 2019, 111 TN ptswith del(17p) were enrolled to receive zanu. The median age was 71 y (range, 42-87 y), 79 (71%) were male, 67 (60%) were IGHV unmutated, and 47 (42%) had both del(17p) and TP53 mutation. At a median follow-up of 65.8 mo (range, 5-75 mo), median PFS was not reached. The estimated 60-mo PFS rate was 72.2% (62.4%-79.8%), or 73.0% (63.3%-80.6%) when adjusted f...