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期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2403407

摘要内容如下：

背景

结合蛋白酶体抑制剂、免疫调节剂和抗CD38抗体的三联或四联疗法延长了新诊断的多发性骨髓瘤患者的生存期。然而，大多数患者都会复发。一线来那度胺治疗增加了来那度胺难治性疾病首次复发的患者数量。

方法

在这项3期、随机、开放标签试验中，我们评估了Belantamab mafodotin、泊马度胺和地塞米松（BPD），并与泊马度胺、硼替佐米和地塞米松（PVD）进行了比较，这些患者暴露于来那度胺，在接受至少一种治疗后复发或难治性骨髓瘤。主要终点是无进展生存期。还评估了疾病反应和安全性。

结果

共有302名患者接受了随机分组；155人被分配到BPD组，147人被分配到PVD组。中位随访时间为21.8个月（范围<0.1至39.2个月），BPD患者12个月估计的无进展生存率为71%（95%可信区间[CI]，63-78），而PVD患者为51%（95%CI，42-60）（疾病进展或死亡的风险比为0.52；95%可信区间为0.37~0.73；P<0.001）。总生存率的数据尚不成熟。对治疗有反应（部分反应或更好）的患者百分比在BPD组中为77%（95%CI，70-84），在PVD组中为72%（95%CI，64-79）；分别有40%（95%CI，32至48）和16%（95%CI，11至23）的患者获得完全缓解或更好的缓解。94%的BPD组患者和76%的PVD组患者发生了3级或更高级别的不良事件。89%接受BPD治疗的患者（43%为3级或4级）和30%接受PVD治疗的患者（2%为3级或4级）发生眼部事件；BPD组的眼部事件采用Belantamab mafodotin剂量调整进行治疗。眼部事件导致BPD组中9%的患者停止治疗，而PVD组中没有患者停止治疗。

结论

在来那度胺暴露的复发性或难治性骨髓瘤患者中，BPD在无进展生存期以及更深、更持久的反应方面比PVD具有显著更大的益处。眼部事件是常见的，但可通过Belantamab mafodotin剂量调整进行控制。（由GSK资助；DREAMM-8 ClinicalTrials.gov编号，NCT04484623；Eudract编号，2018-00434-21.）

英文原文如下：

Abstracts

BACKGROUND  Triplet or quadruplet therapies incorporating proteasome inhibitors, immunomodulators, and anti-CD38 antibodies have led to prolonged survival among patients with newly diagnosed multiple myeloma; however, most patients have a relapse. Frontline lenalidomide therapy has increased the number of patients with lenalidomide-refractory disease at the time of the first relapse.

METHODS  In this phase 3, randomized, open-label trial, we evaluated belantamab mafodotin, pomalidomide, and dexamethasone (BPd), as compared with pomalidomide, bortezomib, and dexamethasone (PVd), in lenalidomide-exposed patients who had relapsed or refractory myeloma after at least one line of therapy. The primary end point was progression-free survival. Disease response and safety were also assessed.

RESULTS  A total of 302 patients underwent randomization; 155 were assigned to the BPd group, and 147 to the PVd group. At a median follow-up of 21.8 months (range, <0.1 to 39.2), the 12-month estimated progression-free survival with BPd was 71% (95% confidence interval [CI], 63 to 78), as compared with 51% (95% CI, 42 to 60) with PVd (hazard ratio for disease progression or death, 0.52; 95% CI, 0.37 to 0.73; P<0.001). Data on overall survival were immature. The percentage of patients with a response to treatment (partial response or better) was 77% (95% CI, 70 to 84) in the BPd group and 72% (95% CI, 64 to 79) in the PVd group; 40% (95% CI, 32 to 48) and 16% (95% CI, 11 to 23), respectively, had a complete response or better. Grade 3 or higher adverse events occurred in 94% of the patients in the BPd group and 76% of those in the PVd group. Ocular events occurred in 89% of the patients who received BPd (grade 3 or 4 in 43%) and 30% of those who received PVd (grade 3 or 4 in 2%); ocular events in the BPd group were managed with belantamab mafodotin dose modification. Ocular events led to treatment discontinuation in 9% of the patients in the BPd group and in no patients in the PVd group.

CONCLUSIONS  Among lenalidomide-exposed patients with relapsed or refractory myeloma, BPd conferred a significantly greater benefit than PVd with respect to progression-free survival, as well as deeper, more durable responses. Ocular events were common but were controllable by belantamab mafodotin dose modification. (Funded by GSK; DREAMM-8 ClinicalTrials.gov number, NCT04484623; EudraCT number, 2018-00434-21.).

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