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期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2405090

摘要内容如下：

背景

Belantamab mafodotin在复发性或难治性多发性骨髓瘤患者中具有单药活性，这一发现支持进一步评估该药物与标准护理疗法的联合应用。

方法

在这项3期、开放标签、随机试验中，我们评估了Belantamab mafodotin、硼替佐米和地塞米松（BVD），并与Daratumumab、硼替佐米和地塞米松（DVD）进行比较，这些患者在至少一种治疗后出现多发性骨髓瘤进展。主要终点是无进展生存期。关键的次要终点是总生存率、缓解持续时间和微小残留病（MRD）阴性状态。

结果

共有494名患者被随机分配接受BVD（243名患者）或DVD（251名患者）。中位随访时间为28.2个月（范围0.1至40.0个月），BVD组的中位无进展生存期为36.6个月（95%可信区间[CI]，28.4至未达到），DVD组为13.4个月（95%CI，11.1至17.5）（疾病进展或死亡的风险比为0.41；95%可信区间为0.31~0.53；P<0.001）。BVD组18个月总生存率为84%，DVD组为73%。限制性平均反应持续时间分析显示，BVD优于DVD（P<0.001）。完全缓解或更好加上MRD阴性状态在BVD组中为25%，在DVD组中为10%。95%的BVD组患者和78%的DVD组患者发生了3级或更高级别的不良事件。眼部事件在BVD组比DVD组更常见（79%vs.29%）；这类事件通过剂量调整进行处理，视力恶化的事件大多得到解决。

结论

与DVD疗法相比，BVD疗法在复发或难治性多发性骨髓瘤患者经过至少一系列治疗后的无进展生存期方面具有显著益处。大多数患者出现3级或更高级别的不良事件。（由GSK资助；DREAMM-7 ClinicalTrials.gov编号，NCT04246047；Eudract编号，2018-003993-29.）。

英文原文如下：

Abstracts

BACKGROUND  Belantamab mafodotin had single-agent activity in patients with relapsed or refractory multiple myeloma, a finding that supports further evaluation of the agent in combination with standard-care therapies.

METHODS  In this phase 3, open-label, randomized trial, we evaluated belantamab mafodotin, bortezomib, and dexamethasone (BVd), as compared with daratumumab, bortezomib, and dexamethasone (DVd), in patients who had progression of multiple myeloma after at least one line of therapy. The primary end point was progression-free survival. Key secondary end points were overall survival, response duration, and minimal residual disease (MRD)-negative status.

RESULTS  In total, 494 patients were randomly assigned to receive BVd (243 patients) or DVd (251 patients). At a median follow-up of 28.2 months (range, 0.1 to 40.0), median progression-free survival was 36.6 months (95% confidence interval [CI], 28.4 to not reached) in the BVd group and 13.4 months (95% CI, 11.1 to 17.5) in the DVd group (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). Overall survival at 18 months was 84% in the BVd group and 73% in the DVd group. An analysis of the restricted mean response duration favored BVd over DVd (P<0.001). A complete response or better plus MRD-negative status occurred in 25% of the patients in the BVd group and 10% of those in the DVd group. Grade 3 or higher adverse events occurred in 95% of the patients in the BVd group and 78% of those in the DVd group. Ocular events were more common in the BVd group than in the DVd group (79% vs. 29%); such events were managed with dose modifications, and events of worsening visual acuity mostly resolved.

CONCLUSIONS  As compared with DVd therapy, BVd therapy conferred a significant benefit with respect to progression-free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy. Most patients had grade 3 or higher adverse events. (Funded by GSK; DREAMM-7 ClinicalTrials.gov number, NCT04246047; EudraCT number, 2018-003993-29.).

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