Outcomes by Body Mass Index in Patients With B-Cell Precursor Acute Lymphoblastic Leukemia Treated with Inotuzumab Ozogamicin.

IF 5.1 3区医学 Q2 ONCOLOGY

Targeted Oncology Pub Date : 2026-09-16 DOI:10.1007/s11523-026-01253-w

Wendy Stock, Ryan D Cassaday, Daniel J DeAngelo, Anjali Advani, Nicola Gokbuget, Josep Ribera, Wei Jiang, Susana Pulido, Erik Vandendries, Nathan Braniff, Elias Jabbour, Hagop Kantarjian

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引用次数: 0

Abstract

Background: Inotuzumab ozogamicin (lnO) is approved for the treatment of adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. Elevated body mass index (BMI) could be associated with worse outcomes.

Objective: To conduct post hoc BMI-stratified efficacy/safety analyses of lnO.

Patients and methods: Pooled data from phase 1-4 InO trials were analyzed, with patients grouped by BMI: < 25 kg/m² (normal), 25-30 kg/m² (overweight), and > 30 kg/m² (obese), including a subset of morbidly obese (> 40 kg/m²) patients. Descriptive analyses included efficacy, safety, and pharmacokinetic simulations for InO.

Results: Across 338 patients, complete remission (CR) or CR with incomplete count recovery (CRi) was achieved in 69.7%, 75.9%, 68.7%, and 84.6% patients in the < 25, 25-30, > 30, and > 40 kg/m² subgroups, respectively. The 24-month probability of progression-free survival was 19.9%, 12.8%, 10.9%, and 23.1%; the 24-month overall survival probability was 28.1%, 22.1%, 17.5%, and 23.1% in these subgroups, respectively. Most deaths were due to progressive disease. Most patients experienced treatment-emergent adverse events (TEAEs), with similar incidence across subgroups. The most common grade ≥ 3 TEAE was neutropenia (36.1%), with sinusoidal obstruction syndrome (SOS) observed in 8.3%. 143 patients (42%) proceeded to hematopoietic stem cell transplant (HSCT) after lnO treatment, with 31 (21.7%) experiencing post-HSCT SOS; the BMI > 40 kg/m² subgroup (n = 7 receiving HSCT) had the numerically highest post-HSCT non-relapse mortality. In simulations for dose capping (capped maximum dose), exposure metrics were similar across subgroups with/without dose capping.

Conclusion: Efficacy/safety outcomes with InO were consistent across BMI subgroups. Dose-capping does not appear to be required.

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用Inotuzumab Ozogamicin治疗b细胞前体急性淋巴母细胞白血病患者的体重指数结果

背景：Inotuzumab ozogamicin （lnO）被批准用于治疗复发/难治性b细胞前体急性淋巴细胞白血病的成人。身体质量指数（BMI）升高可能与更糟糕的结果有关。目的：对lnO进行事后bmi分层疗效/安全性分析。患者和方法：对来自1-4期InO试验的汇总数据进行分析，患者按BMI分为：2（正常），25-30 kg/m2（超重）和bbb30 kg/m2（肥胖），包括病态肥胖（> 40 kg/m2）患者。描述性分析包括InO的疗效、安全性和药代动力学模拟。结果：在338例患者中，在30和40 kg/m2亚组中，分别有69.7%、75.9%、68.7%和84.6%的患者达到完全缓解（CR）或CR伴有不完全计数恢复（CRi）。24个月无进展生存概率分别为19.9%、12.8%、10.9%和23.1%；这些亚组的24个月总生存率分别为28.1%、22.1%、17.5%和23.1%。大多数死亡是由于疾病的进展。大多数患者经历治疗后出现的不良事件（teae），亚组发生率相似。最常见的≥3级TEAE为中性粒细胞减少症（36.1%），8.3%为窦状窦阻塞综合征（SOS）。143例（42%）患者在lnO治疗后继续进行造血干细胞移植（HSCT）， 31例（21.7%）患者在HSCT后出现SOS；BMI指数为40 kg/m2的亚组（n = 7名接受HSCT的患者）的HSCT后非复发死亡率最高。在剂量上限（上限最大剂量）的模拟中，有/没有剂量上限的亚组的暴露指标相似。结论：InO的疗效/安全性结果在BMI亚组中是一致的。似乎不需要设置剂量上限。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

期刊介绍： Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes: Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches. Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways. Current Opinion articles that place interesting areas in perspective. Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations. Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement. Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.