Real-World Outcomes Among Medicare Beneficiaries Treated with Bruton Tyrosine Kinase Inhibitors for Treatment-Naïve CLL.

IF 3.4 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2026-09-01 Epub Date: 2026-06-22 DOI:10.1007/s40487-026-00452-9

Daniel A Ermann, Deborah M Stephens, Xiaoliang Wang, Irene Varghese, Heidi De Souza, Caitlin Sheetz, Qianhong Fu, Gregory A Maglinte, Rhys Williams, Erlene K Seymour, Derrick van Beuge, Mazyar Shadman, Ryan Jacobs

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引用次数: 0

Abstract

Introduction: There is a dearth of head-to-head studies comparing covalent Bruton tyrosine kinase (cBTK) inhibitors in adults with chronic lymphocytic leukemia (CLL). Real-world evidence may complement clinical trial data by assessing relative effectiveness in routine practice. This retrospective observational study used a de-identified Medicare Fee-For-Service database to compare real-world outcomes associated with first-line cBTKi monotherapies in older adults with CLL.

Methods: Patients aged ≥ 65 years with CLL initiating first-line ibrutinib, acalabrutinib, or zanubrutinib monotherapy between January 1, 2020 and September 30, 2025 were included. Real-world time to treatment discontinuation (rwTTD), time to next treatment (rwTTNT), and overall survival (rwOS) were evaluated using Kaplan-Meier analyses and Cox proportional hazards models. Subgroup analyses were performed by age group.

Results: Among 10,523 patients included, 3006 (28.6%) received zanubrutinib (median follow-up 15.8 months), 4309 (40.9%) received acalabrutinib (20.7 months), and 3208 (30.5%) received ibrutinib (34.9 months). Median rwTTD was not reached (NR) for zanubrutinib, compared with 24 months for acalabrutinib and 14 months for ibrutinib. Median rwTTNT was NR for zanubrutinib, 40 months for acalabrutinib, and 20 months for ibrutinib. After adjustments for age, sex, race, CCI, and year of index, zanubrutinib had significantly longer rwTTD (hazard ratio [HR] 0.57 [95% CI 0.51-0.61]), rwTTNT (HR 0.63 [0.55-0.71]), and rwOS (HR 0.64 [0.54-0.77]) compared to ibrutinib. Zanubrutinib also had significantly improved rwTTD (HR 0.86 [0.78-0.94]), rwTTNT (HR 0.87 [0.78-0.96]), and rwOS (HR 0.77 [0.66-0.88]) compared to acalabrutinib. Similar patterns were observed when stratified by age group over 65.

Conclusions: These findings demonstrate that zanubrutinib is associated with improved real-world outcomes compared with other cBTK inhibitors.

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布鲁顿酪氨酸激酶抑制剂治疗Treatment-Naïve CLL的医疗保险受益人的实际结果。

目前缺乏比较成人慢性淋巴细胞白血病（CLL）患者的共价布鲁顿酪氨酸激酶（cBTK）抑制剂的头对头研究。真实世界的证据可以通过评估常规实践中的相对有效性来补充临床试验数据。这项回顾性观察性研究使用了一个去识别的医疗服务收费数据库来比较老年慢性淋巴细胞白血病患者一线cBTKi单药治疗的实际结果。方法：纳入2020年1月1日至2025年9月30日期间接受一线依鲁替尼、阿卡拉布替尼或扎鲁替尼单药治疗的年龄≥65岁CLL患者。使用Kaplan-Meier分析和Cox比例风险模型评估实际治疗停药时间（rwTTD）、下一次治疗时间（rwTTNT）和总生存期（rwOS）。按年龄组进行亚组分析。结果：纳入的10523例患者中，3006例（28.6%）患者接受扎努鲁替尼治疗（中位随访15.8个月），4309例（40.9%）患者接受阿卡拉布替尼治疗（20.7个月），3208例（30.5%）患者接受伊鲁替尼治疗（34.9个月）。zanubrutinib的中位rwTTD未达到（NR），而acalabrutinib为24个月，ibrutinib为14个月。扎鲁替尼的中位rwTTNT为NR，阿卡拉布替尼为40个月，伊鲁替尼为20个月。在调整了年龄、性别、种族、CCI和年份指数后，与伊鲁替尼相比，扎鲁替尼的rwTTD（风险比[HR] 0.57 [95% CI 0.51-0.61]）、rwTTNT （HR 0.63[0.55-0.71]）和rwOS （HR 0.64[0.54-0.77]）明显更长。与阿卡拉布替尼相比，Zanubrutinib也显著改善了rwTTD （HR 0.86[0.78-0.94]）、rwTTNT （HR 0.87[0.78-0.96]）和rwOS （HR 0.77[0.66-0.88]）。在65岁以上的年龄组中也观察到类似的模式。结论：这些发现表明，与其他cBTK抑制剂相比，zanubrutinib与改善的现实预后相关。

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来源期刊

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. 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