PDF(Pubmed)
Abstract：
UNASSIGNED: Parsaclisib, a potent and highly selective PI3Kδ inhibitor, has shown clinical benefit in patients with relapsed or refractory (R/R) B-cell malignancies. This phase 2 study (CITADEL-203; NCT03126019, EudraCT 2017-001624-22) assessed efficacy and safety of parsaclisib monotherapy in patients with R/R follicular lymphoma (FL).
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.
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.
摘要：
■Parsaclisib，一种有效和高度选择性的PI3Kδ抑制剂，已在复发或难治性（R/R）B细胞恶性肿瘤患者中显示出临床益处。这项2期研究（CITADEL-203;NCT03126019，EudraCT2017-001624-22）评估了Parsaclisib单一疗法在R/R滤泡性淋巴瘤（FL）患者中的疗效和安全性。
■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。
■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。
