Background: Multiple myeloma (MM) is an incurable plasma cell dyscrasia with particularly adverse prognosis in relapsed, multi-drug refractory settings. The management of those patients is challenging as treatment options are limited. In this context, bispecific antibodies (BsAbs) have recently emerged as promising therapeutic agents, and several have gained regulatory approval. To better understand their impact in MM landscape, we performed a systematic review and meta-analysis assessing their efficacy and safety in patients with relapsed/refractory MM (RRMM).Methods: A systematic search was conducted in the PubMed, ScienceDirect, Scopus and ClinicalTrials.gov databases for clinical trials investigating BsAbs for RRMM. Pooled estimates in terms of proportions along with 95% confidence intervals were calculated with random-effects models. The present meta-analysis was performed following PRISMA guidelines and was registered in PROSPERO (ID: CRD420251028553).Results: Based on data from six clinical trials involving 850 patients, the pooled overall response and complete response or better rates were 69% and 42%, respectively, whereas the pooled rate of duration of response for at least one year was 71%. The estimated one-year progression-free survival and overall survival were 56% and 72%, respectively. Neutropenia was the most frequently observed severe hematological toxicity, with a pooled incidence of 46%. Grade ≥3 infections occurred in 29%, while any-grade CRS occurred in 69%, as per pooled analysis. Finally, an exploratory minimal residual disease (MRD) analysis in four of the six studies yielded a pooled MRD-negativity rate of 24%.Conclusions: BsAbs demonstrated commendable efficacy in heavily pretreated RRMM patients, in terms of response rates and survival outcomes. However, notable rates of hematologic toxicity, infections, and CRS were recorded. These findings support the clinical utility of BsAbs in RRMM, while highlighting the need for comprehensive toxicity management.
背景：多发性骨髓瘤（MM）是一种无法治愈的浆细胞恶性增殖性疾病，在复发且对多种药物耐药的病例中预后尤其不良。由于治疗选择有限，这类患者的管理具有挑战性。在此背景下，双特异性抗体（BsAbs）近年来已成为有前景的治疗药物，其中数种已获得监管批准。为了更好地理解其在MM治疗领域的影响，我们进行了一项系统综述和荟萃分析，以评估其在复发/难治性多发性骨髓瘤（RRMM）患者中的疗效和安全性。 方法：在PubMed、ScienceDirect、Scopus和ClinicalTrials.gov数据库中系统检索了针对RRMM的BsAbs临床试验。采用随机效应模型计算了比例及其95%置信区间的合并估计值。本荟萃分析遵循PRISMA指南进行，并已在PROSPERO注册（ID：CRD420251028553）。 结果：基于涉及850名患者的六项临床试验数据，合并的总缓解率和完全缓解或更好缓解率分别为69%和42%，而缓解持续时间至少一年的合并率为71%。估计的一年无进展生存率和总生存率分别为56%和72%。中性粒细胞减少是最常观察到的严重血液学毒性，合并发生率为46%。根据合并分析，≥3级感染发生率为29%，而任何级别的细胞因子释放综合征（CRS）发生率为69%。最后，对六项研究中的四项进行的探索性微小残留病（MRD）分析得出，合并的MRD阴性率为24%。 结论：在缓解率和生存结局方面，BsAbs在经深度治疗的RRMM患者中显示出值得称赞的疗效。然而，也记录了显著的血液学毒性、感染和CRS发生率。这些发现支持了BsAbs在RRMM中的临床应用价值，同时强调了进行全面毒性管理的必要性。
肿瘤(癌症)患者之家