An indirect comparison of zanubrutinib vs acalabrutinib plus venetoclax in patients with treatment-naive CLL.

In the phase 3 AMPLIFY study (NCT03836261), acalabrutinib-venetoclax with or without obinutuzumab demonstrated prolonged PFS vs chemoimmunotherapy (investigator's choice of fludarabine, cyclophosphamide, and rituximab [FCR] or BR) in patients with treatment-naive CLL without del(17p) or TP53 mutations.

在第3阶段AMPLIFY研究(NCT03836261)中，acalabrutinib-venetoclax无论是否联合obinutuzumab，与化疗免疫治疗（研究者选择的氟达拉滨、环磷酰胺和利妥昔单抗[FCR]或BR）相比，均显示出在未经治疗的CLL患者中，未携带del(17p)或TP53突变的情况下，无进展生存期（PFS）延长。

Compared with AMPLIFY, the patient population in SEQUOIA was unsuitable for FCR and included patients with TP53 mutations.

与AMPLIFY相比，SEQUOIA中的患者群体不适合FCR治疗，并包括了携带TP53突变的患者。

The aim of this post hoc analysis was to investigate the efficacy of zanubrutinib in patients from SEQUOIA vs a clinically similar patient population treated with acalabrutinib-venetoclax in AMPLIFY.

本次事后分析的目的是调查在SEQUOIA中的患者使用zanubrutinib的疗效，与在AMPLIFY中接受acalabrutinib-venetoclax治疗的临床相似患者群体进行比较。

A numerically greater 3-year investigator-assessed PFS (PFS-INV) was observed with zanubrutinib (84.3%) in the SEQUOIA population vs acalabrutinib-venetoclax in AMPLIFY (78.9%).

在SEQUOIA人群中，研究者评估的3年无进展生存期（PFS-INV）在使用zanubrutinib治疗的患者中观察到更高的数值（84.3%），与在AMPLIFY研究中使用acalabrutinib-venetoclax治疗的患者相比（78.9%）。

When matching SEQUOIA to the AMPLIFY population by FCR eligibility, a greater PFS benefit with zanubrutinib was reported (89.2% vs 78.9%, respectively).

当根据FCR资格将SEQUOIA人群与AMPLIFY人群进行匹配时，报告了zanubrutinib更大的PFS获益（分别为89.2%和78.9%）。

To support the comparison of zanubrutinib vs acalabrutinib-venetoclax, an anchored matching-adjusted indirect comparison was performed, which showed that zanubrutinib was associated with prolonged PFS-INV vs acalabrutinib-venetoclax when adjusted for various baseline characteristics.

为了支持泽布替尼与阿卡布替尼-维奈克拉的比较，进行了锚定匹配调整间接比较，结果显示，在调整了各种基线特征后，泽布替尼与延长的无进展生存期（PFS-INV）相关，与阿卡布替尼-维奈克拉相比。

Zanubrutinib also demonstrated longer PFS whether adjusted for age (PFS-INV hazard ratio[HR], 0.26; 95% confidence interval[CI], 0.13-0.54; P< .0003) or unadjusted (PFS-INV HR, 0.45; 95% CI, 0.23-0.88; P = .0197).

无论是否根据年龄调整（PFS-INV风险比[HR]，0.26；95%置信区间[CI]，0.13-0.54；P< .0003）或未调整（PFS-INV HR，0.45；95% CI，0.23-0.88；P = .0197），泽布替尼均显示出更长的无进展生存期（PFS）。

These results highlight zanubrutinib monotherapy as an effective treatment option for all patients with treatment-naive CLL/SLL, including patients who might otherwise be considered for more intensive fixed-duration combination regimens.

这些结果强调了zanubrutinib单药治疗作为所有治疗前慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者的有效治疗选择，包括那些可能原本会考虑接受更密集固定期限联合治疗方案的患者。