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依沙妥昔单抗:在多发性骨髓瘤中的应用评价。

Isatuximab: A Review of Its Use in Multiple Myeloma.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Target Oncol. 2021 Sep;16(5):675-686. doi: 10.1007/s11523-021-00827-0. Epub 2021 Aug 5.

Abstract

Isatuximab (Sarclisa; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor; and in combination with carfilzomib and dexamethasone for those with relapsed MM who have received ≥ 1 prior therapy. In phase III studies, the addition of isatuximab to pomalidomide and dexamethasone significantly prolonged progression-free survival (PFS) and improved the depth of tumour response in patients with RRMM, as did the addition of isatuximab to carfilzomib and dexamethasone in patients with relapsed or refractory MM. Health-related quality of life was maintained when isatuximab was combined with these other therapies. Isatuximab-based combination therapies were generally well tolerated and demonstrated a manageable safety profile with no new safety signals. Although mature overall survival data are awaited, available evidence indicates that the combinations of isatuximab with pomalidomide and dexamethasone and isatuximab with carfilzomib and dexamethasone are important additional treatment options for RRMM and relapsed MM, respectively.

摘要

依沙佐米(Sarclisa;在美国称为 isatuximab-irfc)是一种抗 CD38 单克隆抗体(mAb),已批准用于治疗多发性骨髓瘤(MM)成人患者:与泊马度胺和地塞米松联合用于复发和难治性 MM(RRMM)患者,这些患者接受过 ≥ 2 种既往治疗,包括来那度胺和蛋白酶体抑制剂;与卡非佐米和地塞米松联合用于接受过 ≥ 1 种既往治疗的复发 MM 患者。在 III 期研究中,与泊马度胺和地塞米松联合应用依沙佐米显著延长了 RRMM 患者的无进展生存期(PFS),并提高了肿瘤缓解的深度,与卡非佐米和地塞米松联合应用依沙佐米在复发或难治性 MM 患者中也是如此。当依沙佐米与这些其他疗法联合使用时,患者的健康相关生活质量得以维持。依沙佐米为基础的联合治疗总体上耐受性良好,具有可管理的安全性,没有新的安全性信号。尽管仍在等待成熟的总生存期数据,但现有证据表明,依沙佐米联合泊马度胺和地塞米松以及依沙佐米联合卡非佐米和地塞米松分别是 RRMM 和复发 MM 的重要附加治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf17/8497289/8b946bb5f8aa/11523_2021_827_Fig1_HTML.jpg

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