Outcomes after transition from ibrutinib to zanubrutinib in patients with Waldenström macroglobulinemia from the ASPEN study.

In the phase 3 ASPEN study (BGB-3111-302), comparable efficacy and a favorable safety profile vs ibrutinib were demonstrated in patients with MYD88 (myeloid differentiation primary response 88)-mutated Waldenström macroglobulinemia (WM), leading to approval of zanubrutinib for patients with WM.

在第3阶段的ASPEN研究（BGB-3111-302）中，与伊布替尼相比，泽布替尼在携带MYD88（髓样分化原反应蛋白88）突变的华氏巨球蛋白血症（WM）患者中显示出相当的疗效和良好的安全性，这导致了泽布替尼被批准用于WM患者的治疗。

BGB-3111-LTE1 (LTE1) is a long-term extension study to which eligible patients, including patients from comparator treatment arms, could enroll after participation in various parent studies of zanubrutinib to treat B-cell malignancies.

BGB-3111-LTE1 (LTE1) 是一项长期扩展研究，符合条件的患者，包括来自对照治疗组的患者，在参与各种治疗B细胞恶性肿瘤的zanubrutinib的父本研究后，可以登记参加。

Here, safety and efficacy are reported in the 47 patients who transitioned from ibrutinib treatment in ASPEN to zanubrutinib in LTE1.

在这里，报告了47名从ASPEN的ibrutinib治疗过渡到LTE1的zanubrutinib治疗的患者的疗效和安全性。

The median time from ibrutinib treatment initiation to LTE1 enrollment was 50.4 months (range, 26-59.3).

从伊布替尼治疗开始到LTE1入组的中位时间是50.4个月（范围，26-59.3）。

At median LTE1 study follow-up of 15.3 months (range, 6.0-35.1), 85% of patients in this subgroup remained on zanubrutinib treatment.

在LTE1研究的中位随访时间为15.3个月（范围，6.0-35.1）时，该亚组中有85%的患者仍在接受赞布替尼治疗。

The median zanubrutinib treatment duration was 15.3 months.

zanubrutinib治疗的中位持续时间是15.3个月。

Despite advanced and increasing patient age, most ibrutinib treatment-emergent adverse events of interest for BTK inhibitors did not recur or worsen with zanubrutinib.

尽管患者的年龄增长且病情进展，但大多数与BTK抑制剂相关的ibrutinib治疗后出现的不良事件在使用zanubrutinib后并未复发或加重。

WM disease response was maintained or improved in 44 of 46 efficacy-evaluable patients (96%; n = 2 converted to negative immunofixation).

在46名可评估疗效的患者中，有44名患者的WM疾病反应保持或改善（96%；n=2名患者免疫固定试验转为阴性）。

Although limited by sample size and nonrandomized/ad hoc analyses, data suggest that patients who tolerate ibrutinib may switch to zanubrutinib without compromising safety or efficacy.

尽管样本量有限且为非随机/即兴分析，但数据表明，能够耐受伊布替尼的患者在不损害安全性和有效性的前提下，可以转换为赞布替尼治疗。

Long-term follow-up is ongoing.

长期随访正在进行中。

These trials were registered at www.ClinicalTrials.gov as #NCT03053440 and #NCT04170283.

这些试验已在www.ClinicalTrials.gov上注册，注册号为#NCT03053440和#NCT04170283。

Results

The median time from ibrutinib treatment initiation to LTE1 enrollment was 50.4 months (range, 26-59.3).

从伊布替尼治疗开始到LTE1入组的中位时间是50.4个月（范围，26-59.3）。