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用贝兰他单抗莫福汀治疗的多发性骨髓瘤患者的真实世界特征和结局:一项德国索赔数据研究。

Real-world characteristics and outcomes of patients with multiple myeloma treated with belantamab mafodotin: a German claims data study.

作者信息

Luna Jaime, d'Estrube Tim, Jacobsen Andreas, Lehne Moritz, Wellmann-Pichler Birgit, Mevius Antje, Dornig Sabine

机构信息

Cytel Inc, Berlin, Germany.

GSK, London, UK.

出版信息

Ann Hematol. 2025 May 31. doi: 10.1007/s00277-025-06427-6.

DOI:10.1007/s00277-025-06427-6
PMID:40448822
Abstract

In the DREAMM-2 trial, belantamab mafodotin (belamaf) monotherapy demonstrated clinical activity and a manageable safety profile in pretreated patients with relapsed/refractory multiple myeloma (RRMM). Real-world evidence on this patient population is scarce. This study describes real-world baseline characteristics, ocular events, and time-to-event outcomes of patients with RRMM before, during, and after belamaf treatment between August 1, 2020, and March 31, 2023, in Germany based on anonymized health insurance claims data. In the overall cohort (N = 31), the median age was 66 years and all patients had received several MM therapies prior to treatment with belamaf. Of the patients included in the pre-belamaf (n = 31), belamaf (n = 31), and post-belamaf (n = 22) treatment periods, 10 (32.3%), 16 (51.6%), and 15 (68.2%) had at least one recorded ophthalmological visit, respectively. Keratitis was the most frequent among ocular diagnoses of interest across all three study periods. During the belamaf treatment period, seven (22.6%) patients had one or more incident ocular diagnoses of interest, the most frequent being corneal-related events. In the overall cohort, the real-world progression-free survival and overall survival were 4.3 months (95% confidence interval [CI] 2.4-7.7) and 12.3 months (95% CI 6.9-not evaluable), respectively. Our data emphasize the importance of ocular supportive care during belamaf treatment in real-world clinical practice. Our findings also highlight that RRMM remains an aggressive disease with a poor prognosis.

摘要

在DREAMM-2试验中,贝兰他单抗莫福汀(belamaf)单药治疗在复发/难治性多发性骨髓瘤(RRMM)的预处理患者中显示出临床活性和可控的安全性。关于这一患者群体的真实世界证据很少。本研究基于匿名的医疗保险理赔数据,描述了2020年8月1日至2023年3月31日期间德国RRMM患者在接受belamaf治疗前、治疗期间和治疗后的真实世界基线特征、眼部事件和事件发生时间结局。在整个队列(N = 31)中,中位年龄为66岁,所有患者在接受belamaf治疗前均接受过多种MM治疗。在纳入belamaf治疗前(n = 31)、belamaf治疗期间(n = 31)和belamaf治疗后(n = 22)的患者中,分别有10例(32.3%)、16例(51.6%)和15例(68.2%)至少有一次记录的眼科就诊。在所有三个研究期间,角膜炎是所有感兴趣的眼部诊断中最常见的。在belamaf治疗期间,7例(22.6%)患者有一次或多次感兴趣的新发眼部诊断,最常见的是与角膜相关的事件。在整个队列中,真实世界的无进展生存期和总生存期分别为4.3个月(95%置信区间[CI] 2.4 - 7.7)和12.3个月(95% CI 6.9 - 不可评估)。我们的数据强调了在真实世界临床实践中belamaf治疗期间眼部支持治疗的重要性。我们的研究结果还突出表明,RRMM仍然是一种侵袭性疾病,预后较差。

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本文引用的文献

1
Treatment Patterns, Efficacy, and Tolerability of Belantamab Mafodotin in Patients With Relapsed and/or Refractory Multiple Myeloma: A Real-World Analysis.复发和/或难治性多发性骨髓瘤患者中贝兰他单抗莫福汀的治疗模式、疗效及耐受性:一项真实世界分析
Clin Lymphoma Myeloma Leuk. 2025 Aug;25(8):e570-e579.e4. doi: 10.1016/j.clml.2025.04.008. Epub 2025 Apr 15.
2
Belantamab mafodotin monotherapy for relapsed or refractory multiple myeloma: a real-world observational study in the United States.贝兰他单抗莫福汀单药治疗复发或难治性多发性骨髓瘤:美国一项真实世界观察性研究
Haematologica. 2025 Mar 1;110(3):753-757. doi: 10.3324/haematol.2024.285893.
3
Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma.
硼替佐米、泊马度胺和地塞米松治疗多发性骨髓瘤。
N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2.
4
Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma.贝兰他单抗马妥昔单抗、硼替佐米和地塞米松治疗多发性骨髓瘤。
N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.
5
Single-agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma: Final analysis of the DREAMM-2 trial.单药贝兰他单抗mafodotin 治疗复发/难治性多发性骨髓瘤患者:DREAMM-2 试验的最终分析。
Cancer. 2023 Dec 1;129(23):3746-3760. doi: 10.1002/cncr.34987. Epub 2023 Aug 25.
6
FDA Approval Summary: Belantamab Mafodotin for Patients with Relapsed or Refractory Multiple Myeloma.FDA 批准概要:贝兰他单抗mafodotin 用于治疗复发或难治性多发性骨髓瘤患者。
Clin Cancer Res. 2022 Nov 1;28(21):4629-4633. doi: 10.1158/1078-0432.CCR-22-0618.
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"Real-life" data of the efficacy and safety of belantamab mafodotin in relapsed multiple myeloma-the Mayo Clinic experience.硼替佐米、卡非佐米和来那度胺联合方案治疗多发性骨髓瘤患者的真实世界研究:梅奥诊所的经验
Blood Cancer J. 2021 Dec 7;11(12):196. doi: 10.1038/s41408-021-00592-3.
8
Emerging therapies for relapsed/refractory multiple myeloma: CAR-T and beyond.复发/难治性多发性骨髓瘤的新兴疗法:嵌合抗原受体T细胞疗法及其他。
J Hematol Oncol. 2021 Jul 23;14(1):115. doi: 10.1186/s13045-021-01109-y.
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Ocular Toxicity of Belantamab Mafodotin, an Oncological Perspective of Management in Relapsed and Refractory Multiple Myeloma.贝兰他单抗莫福汀的眼部毒性:复发难治性多发性骨髓瘤治疗的肿瘤学视角
Front Oncol. 2021 May 11;11:678634. doi: 10.3389/fonc.2021.678634. eCollection 2021.
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Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.多发性骨髓瘤:欧洲血液学协会-欧洲肿瘤内科学会诊断、治疗及随访临床实践指南
Ann Oncol. 2021 Mar;32(3):309-322. doi: 10.1016/j.annonc.2020.11.014. Epub 2021 Feb 3.