UNASSIGNED: Patients ≥18 years of age with histologically confirmed R/R FL (grade 1-3a) and prior treatment with ≥2 systemic therapies received parsaclisib 20 mg once daily (QD) for 8 weeks then parsaclisib 20 mg once weekly (weekly dosing group [WG]) or parsaclisib 20 mg QD for 8 weeks then parsaclisib 2.5 mg QD (daily dosing group [DG]); DG was selected for further assessment. Primary endpoint was objective response rate (ORR).
UNASSIGNED: At data cut-off (January 15, 2021), 126 patients had been treated (WG: n = 23; DG: n = 103). ORR (95% confidence interval [CI]) was 77.7% (68.4-85.3) with a complete response rate (95% CI) of 19.4% (12.3-28.4) in DG; median (95% CI) duration of response was 14.7 months (10.4-not estimable [NE]), median progression-free survival was 15.8 months (11.0-NE), and median overall survival was not reached. The most common any-grade treatment-emergent adverse events (TEAEs) among all treated patients included diarrhoea (n = 48, 38.1%), nausea (n = 31, 24.6%), and cough (n = 28, 22.2%); the most common grade ≥3 TEAEs were diarrhoea (n = 15, 11.9%), neutropenia (n = 13, 10.3%), and colitis (n = 7, 5.6%). Dose interruption, reduction, and discontinuation from TEAEs occurred in 46.8% (n = 59), 17.5% (n = 22), and 23.8% (n = 30) of patients, respectively.
UNASSIGNED: Treatment with parsaclisib demonstrated rapid and durable responses, and a manageable safety profile in patients with R/R FL.
UNASSIGNED: Incyte Corporation.
■年龄≥18岁且经组织学证实为R/RFL(1-3a级)且先前接受≥2次全身疗法治疗的患者接受了帕萨利西布20mg每日一次(QD),持续8周,然后接受帕萨利西布20mg每周一次(每周给药组[WG])或帕萨利西布20mgQD持续8周,然后进一步评估。主要终点为客观缓解率(ORR)。
■在数据截止时(2021年1月15日),已治疗126例患者(WG:n=23;DG:n=103)。ORR(95%置信区间[CI])为77.7%(68.4-85.3),DG的完全缓解率(95%CI)为19.4%(12.3-28.4);中位(95%CI)缓解持续时间为14.7个月(10.4-不可估计[NE]),中位无进展生存期为15.8个月(11.0-NE),未达到中位总生存期.在所有接受治疗的患者中,最常见的任何级别治疗引起的不良事件(TEAE)包括腹泻(n=48,38.1%)。恶心(n=31,24.6%),咳嗽(n=28,22.2%);最常见的≥3级TEAE是腹泻(n=15,11.9%),中性粒细胞减少症(n=13,10.3%),和结肠炎(n=7,5.6%)。剂量中断,reduction,TEAE停药发生率为46.8%(n=59),17.5%(n=22),和23.8%(n=30)的患者,分别。
■用parsaclisib治疗表现出快速和持久的反应,以及R/RFL患者的可控安全性。
■Incyte公司。