未经授权:奥列拉布替尼是一种小说,小分子,选择性不可逆布鲁顿酪氨酸激酶抑制剂。本研究的目的是评估奥列拉布替尼治疗复发性或难治性Waldenström巨球蛋白血症(R/RWM)患者的疗效和安全性。
未经批准:这是一个潜在的,奥列拉布替尼在至少接受过一次先前治疗的WM患者中的多中心研究。奥列拉布替尼以150mg的日剂量口服给药直至疾病进展或不可接受的毒性。主要终点是独立审查委员会(IRC)根据IWWM-6评估的主要反应率(MRR)。这项研究在ClinicalTrials.gov注册,NCT04440059。该试验也在药物评价中心注册(www.chinadrugtrials.org.cn)2019年3月,与CTR2019036号。
未经评估:在2019年8月至2020年12月之间,对66名R/RWM患者进行了资格评估。在中位随访16.4个月(四分位距:12.5,19.5)时,对47名符合条件的患者进行了疗效评估。根据IRC的评估,MRR为80.9%,总有效率为89.4%。达到至少轻微反应的中位时间为1.9个月。12个月PFS率为89.4%。对于MYD88L265P/CXCR4NEG患者,MYD88L265P/CXCR4S338X,和MYD88NEG/CXCR4NEG突变,MRR为84.6%,100%,和25.0%。大多数不良事件为1级或2级(91.0%)。常见的3级或更高的不良事件发生为中性粒细胞减少症(10.6%),血小板减少症(6.4%),和肺炎(4.3%)。严重不良事件(SAE)有10例(21.3%)。报告了一例与治疗相关的死亡(乙型肝炎再激活)。
UNASSIGNED:奥列拉布替尼在R/RWM患者中显示出良好的疗效和可控制的安全性。
未经批准:InnoCarePharma。
UNASSIGNED: Orelabrutinib is a novel, small molecule, selective irreversible Bruton tyrosine kinase inhibitor. The purpose of this study was to evaluate the efficacy and safety of orelabrutinib in patients with relapsed or refractory Waldenström\'s macroglobulinemia (R/R WM).
UNASSIGNED: This is a prospective, multicenter study of orelabrutinib in patients with WM who had at least one prior line of treatment. Orelabrutinib was administered orally at a daily dose of 150 mg until disease progression or unacceptable toxicity. The primary endpoint was major response rate (MRR) assessed by the Independent Review Committee (IRC) according to IWWM-6. This study is registered with ClinicalTrials.gov, NCT04440059. This trial was also registered on Center for Drug Evaluation (www.chinadrugtrials.org.cn) in March 2019, with a number of CTR2019036.
UNASSIGNED: Between August 2019 and December 2020, 66 R/R WM patients were assessed for eligibility. Forty-seven eligible patients were evaluated for efficacy at a median follow-up of 16.4 months (interquartile range: 12.5, 19.5). As assessed by IRC, the MRR was 80.9%, and the overall response rate was 89.4%. The median time to at least a minor response was 1.9 months. The PFS rates was 89.4% at 12 months. For patients with MYD88L265P /CXCR4NEG, MYD88L265P /CXCR4 S338X, and MYD88NEG /CXCR4NEG mutations, the MRRs were 84.6%, 100%, and 25.0%. Most adverse events were Grades 1 or 2 (91.0%). The common grade 3 or higher adverse events occurring were neutropenia (10.6%), thrombocytopenia (6.4%), and pneumonia (4.3%). Serious adverse events (SAE) occurred in 10 patients (21.3%). One treatment-related death was reported (hepatitis B reactivation).
UNASSIGNED: Orelabrutinib has shown good efficacy and manageable safety profiles in patients with R/R WM.
UNASSIGNED: InnoCare Pharma.