Richter Joshua, Nooka Ajay, Rodríguez-Otero Paula, Schjesvold Fredrik, Katodritou Eirini, Combe Emily, Scott Marianne, Cooper Leanne, Sly Indeg, Ballew Nick, Bitetti Jacopo, Boytsov Natalie, Purser Molly, McNamara Simon
Mount Sinai, New York, New York, USA.
Winship Cancer Institute of Emory University, Atlanta, Georgia, USA.
Am J Hematol. 2025 Jun;100(6):998-1009. doi: 10.1002/ajh.27661. Epub 2025 Mar 27.
In the Phase 3 DREAMM-7 study of patients with relapsed/refractory multiple myeloma (RRMM) who received ≥ 1 prior therapy, belantamab mafodotin plus bortezomib and dexamethasone (BVd) demonstrated a progression-free survival (PFS) benefit versus daratumumab plus bortezomib and dexamethasone (DVd). This study aimed to indirectly compare the efficacy of BVd against alternative regimens in this patient population. A systematic literature review (SLR; December 2021-February 4, 2024) was performed to identify relevant efficacy data. Studies were selected based on the Population-Intervention-Comparators-Outcomes-Study design framework criteria and independently reviewed for inclusion in the network meta-analysis (NMA) if they had a connection to DREAMM-7 (approved in the US or EU, or likely to be a future DREAMM-7 comparator). Each trial had a common comparator arm, allowing for a connected network between the trials and linkage by shared treatments. The primary analysis was PFS in the intent-to-treat population from each study, and secondary analyses examined other endpoints. All endpoints were also evaluated in subgroups by lenalidomide-exposure, -refractoriness, and other patient characteristics. The SLR identified 12 comparator studies comprising 12 comparator regimens (each contained a proteasome inhibitor [bortezomib or carfilzomib] plus dexamethasone), all of which were included in the NMA with the DREAMM-7 study. BVd improved PFS versus all comparators, including daratumumab plus carfilzomib and dexamethasone, isatuximab plus carfilzomib and dexamethasone, and DVd. Overall survival was also improved by belantamab mafodotin plus bortezomib and dexamethasone over the other regimens. This study provides compelling evidence for belantamab mafodotin, plus bortezomib and dexamethasone, in early lines of treatment for RRMM.
在一项针对接受过≥1线既往治疗的复发/难治性多发性骨髓瘤(RRMM)患者的3期DREAMM-7研究中,与达雷妥尤单抗联合硼替佐米和地塞米松(DVd)相比,贝兰他单抗莫福汀联合硼替佐米和地塞米松(BVd)显示出无进展生存期(PFS)获益。本研究旨在间接比较BVd与该患者群体中其他方案的疗效。进行了一项系统文献综述(SLR;2021年12月至2024年2月4日)以确定相关疗效数据。根据人群-干预-对照-结局-研究设计框架标准选择研究,如果这些研究与DREAMM-7(在美国或欧盟获批,或可能成为未来DREAMM-7的对照)相关,则独立评估其是否纳入网络荟萃分析(NMA)。每个试验都有一个共同的对照臂,从而使各试验之间形成一个连通网络,并通过共享治疗进行关联。主要分析是各研究意向性治疗人群的PFS,次要分析则考察其他终点。所有终点还按来那度胺暴露、难治性及其他患者特征在亚组中进行评估。SLR确定了12项对照研究,包含12种对照方案(每种方案均包含一种蛋白酶体抑制剂[硼替佐米或卡非佐米]加地塞米松),所有这些研究均与DREAMM-7研究一起纳入NMA。与所有对照方案相比,BVd均改善了PFS,这些对照方案包括达雷妥尤单抗联合卡非佐米和地塞米松、isatuximab联合卡非佐米和地塞米松以及DVd。与其他方案相比,贝兰他单抗莫福汀联合硼替佐米和地塞米松也改善了总生存期。本研究为贝兰他单抗莫福汀联合硼替佐米和地塞米松用于RRMM的早期治疗提供了有力证据。