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抗CD38抗体isatuximab给药便利性的最新进展:皮下给药及在多发性骨髓瘤患者中的快速静脉输注

Recent Developments in Convenience of Administration of the Anti-CD38 Antibody Isatuximab: Subcutaneous Delivery and Fast Intravenous Infusion in Patients With Multiple Myeloma.

作者信息

Quach Hang, Parmar Gurdeep, Mateos Maria-Victoria, Ailawadhi Sikander, Leleu Xavier

机构信息

Clinical Haematology Service, St Vincent's Hospital Melbourne, University of Melbourne, Vic, Australia.

Illawarra Cancer Care Centre, Wollongong, NSW, Australia.

出版信息

Clin Lymphoma Myeloma Leuk. 2024 Jun;24(6):358-363. doi: 10.1016/j.clml.2024.02.004. Epub 2024 Feb 12.

Abstract

Isatuximab-based combinations are among the accepted standard-of-care regimens for early-line treatment of patients with relapsed/refractory multiple myeloma (RRMM), based on the results of the Phase 3 ICARIA-MM and IKEMA trials. Further study findings have shown benefit with Isa-based combinations in patients with newly diagnosed MM, as reported from the randomized GMMG-HD7 and CONCEPT trials. Isa is currently approved in various countries for intravenous (IV) administration in patients with RRMM. A more convenient route of administration, such as subcutaneous (SC) injection, and faster IV infusion may substantially increase convenience of treatment. In this review, we outline evidence emerging from clinical trials that shows increasing clinical applicability of Isa across the MM therapeutic spectrum. We then review recent study results demonstrating that new treatment modalities, either SC Isa administration via an on-body delivery system (OBDS) or fast, 30-minute, fixed-volume IV infusion, are safe and effective, and enhance convenience of treatment with Isa for MM patients and healthcare providers. In the recently reported Phase 1b study, the safety profile and efficacy of Isa administered SC plus pomalidomide-dexamethasone were comparable to those observed with Isa administered IV plus pomalidomide-dexamethasone in the control arm and in the ICARIA-MM trial. Analysis of patient-reported outcomes indicated patient confidence in SC Isa administration and satisfaction with treatment delivery by OBDS. These findings point to SC administration as the preferred route for future treatment with Isa-based combinations, as well as to the use of fast, 30-minute IV infusions in settings where SC administration of Isa might not be available.

摘要

基于3期ICARIA-MM和IKEMA试验的结果,以isatuximab为基础的联合用药方案是复发/难治性多发性骨髓瘤(RRMM)患者一线治疗公认的标准治疗方案之一。进一步的研究结果表明,如随机GMMG-HD7和CONCEPT试验所报告的,以isatuximab为基础的联合用药方案对新诊断的MM患者有益。Isatuximab目前在各国被批准用于RRMM患者的静脉注射。一种更方便的给药途径,如皮下注射,以及更快的静脉输注可能会大大提高治疗的便利性。在本综述中,我们概述了临床试验中出现的证据,这些证据表明isatuximab在MM治疗范围内的临床适用性不断增加。然后,我们回顾了最近的研究结果,这些结果表明,新的治疗方式,即通过体内给药系统(OBDS)进行皮下isatuximab给药或快速、30分钟固定体积静脉输注,是安全有效的,并且提高了MM患者和医疗服务提供者使用isatuximab治疗的便利性。在最近报告的1b期研究中,皮下注射isatuximab联合泊马度胺-地塞米松的安全性和疗效与对照组以及ICARIA-MM试验中静脉注射isatuximab联合泊马度胺-地塞米松的安全性和疗效相当。对患者报告结果的分析表明患者对皮下注射isatuximab有信心,并且对OBDS给药方式感到满意。这些发现表明皮下给药是未来使用以isatuximab为基础的联合用药方案进行治疗的首选途径,同时也表明在无法进行皮下注射isatuximab的情况下,可使用快速、30分钟静脉输注。

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