Fixed-duration ibrutinib plus venetoclax for first-line treatment of CLL: primary analysis of the CAPTIVATE FD cohort

威尼斯人 伊布替尼 医学 内科学 中性粒细胞减少症 临床终点 人口 发热性中性粒细胞减少症 慢性淋巴细胞白血病 胃肠病学 肿瘤科 化疗 临床试验 白血病 环境卫生
作者
Constantine S. Tam,John N. Allan,Tanya Siddiqi,Thomas J. Kipps,Ryan Jacobs,Stephen Opat,Paul M. Barr,Alessandra Tedeschi,Livio Trentin,Rajat Bannerji,Sharon Jackson,Bryone J. Kuss,Carol Moreno,Edith Szafer‐Glusman,Kristin Russell,Cathy Zhou,Joi Ninomoto,James P. Dean,William G. Wierda,Paolo Ghia
出处
期刊:Blood [Elsevier BV]
卷期号:139 (22): 3278-3289 被引量:149
标识
DOI:10.1182/blood.2021014488
摘要

CAPTIVATE (NCT02910583) is an international phase 2 study in patients aged ≤70 years with previously untreated chronic lymphocytic leukemia (CLL). Results from the cohort investigating fixed-duration (FD) treatment with ibrutinib plus venetoclax are reported. Patients received 3 cycles of ibrutinib lead-in then 12 cycles of ibrutinib plus venetoclax (oral ibrutinib [420 mg/d]; oral venetoclax [5-week ramp-up to 400 mg/d]). The primary endpoint was complete response (CR) rate. Hypothesis testing was performed for patients without del(17p) with prespecified analyses in all treated patients. Secondary endpoints included undetectable minimal residual disease (uMRD) rates, progression-free survival (PFS), overall survival (OS), and safety. Of the 159 patients enrolled and treated, 136 were without del(17p). The median time on study was 27.9 months, and 92% of patients completed all planned treatment. The primary endpoint was met, with a CR rate of 56% (95% confidence interval [CI], 48-64) in patients without del(17p), significantly higher than the prespecified 37% minimum rate (P < .0001). In the all-treated population, CR rate was 55% (95% CI, 48-63); best uMRD rates were 77% (peripheral blood [PB]) and 60% (bone marrow [BM]); 24-month PFS and OS rates were 95% and 98%, respectively. At baseline, 21% of patients were in the high tumor burden category for tumor lysis syndrome (TLS) risk; after ibrutinib lead-in, only 1% remained in this category. The most common grade ≥3 adverse events (AEs) were neutropenia (33%) and hypertension (6%). First-line ibrutinib plus venetoclax represents the first all-oral, once-daily, chemotherapy-free FD regimen for patients with CLL. FD ibrutinib plus venetoclax achieved deep, durable responses and promising PFS, including in patients with high-risk features.
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