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Drugs. 2019 Mar;79(4):447-454. doi: 10.1007/s40265-019-01080-6.
Intravenous daratumumab (DARZALEX) is a human CD38 monoclonal antibody approved as combination therapy (with bortezomib, melphalan and prednisone) for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (ASCT). The approval was based on results of the phase 3 ALCYONE trial in which the addition of daratumumab to bortezomib, melphalan and prednisone significantly prolonged median progression-free survival (PFS) relative to bortezomib, melphalan and prednisone alone (primary endpoint). Daratumumab addition was also associated with deeper and durable responses relative to the comparator. The addition of daratumumab did not increase overall toxicity, with the exception of infusion-related reactions and increased rates of infections. The incidences of the most common grade 3 or 4 adverse events in the daratumumab group (neutropenia, thrombocytopenia and anaemia) were largely similar to those in the comparator group. Thus, daratumumab in combination with bortezomib, melphalan and prednisone represents a promising treatment option for patients with NDMM who are ineligible for ASCT.
静脉注射达雷妥尤单抗（DARZALEX）是一种人源化 CD38 单克隆抗体，获批与硼替佐米、来那度胺和地塞米松联合用于不适合自体干细胞移植（ASCT）的新诊断多发性骨髓瘤（NDMM）患者。该批准基于 3 期 ALCYONE 试验的结果，与硼替佐米、来那度胺和地塞米松单药治疗相比，达雷妥尤单抗的加入显著延长了中位无进展生存期（PFS）（主要终点）。与对照药物相比，达雷妥尤单抗的加入还与更深和更持久的反应相关。除了输注相关反应和感染率增加外，达雷妥尤单抗的加入并未增加总体毒性。达雷妥尤单抗组（中性粒细胞减少症、血小板减少症和贫血症）最常见的 3 级或 4 级不良事件的发生率与对照组大致相似。因此，达雷妥尤单抗联合硼替佐米、来那度胺和地塞米松为不适合 ASCT 的 NDMM 患者提供了一种有前途的治疗选择。
