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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-023-02703-y

摘要内容如下：

由于新诊断的多发性骨髓瘤的治疗标准不断发展，许多患者在最初复发后将暴露于三级，并且生存率较低。因此，需要新的疗法和组合来改善结果。以B细胞成熟抗原（BCMA）为靶点的生物制剂已成为治疗复发性多发性骨髓瘤的一个重要的新领域。由两部分组成的Algonquin试验评估了抗BCMA抗体-药物结合物Belantamab mafodotin联合泊马度胺和地塞米松治疗来那度胺难治性和暴露于蛋白体抑制剂的患者的各种剂量和方案。达到了主要终点，包括评估剂量限制性毒性、确定推荐的第2部分剂量（RP2D）和接受RP2D治疗的患者的总体缓解率。次要疗效终点包括无进展生存期和总生存期。研究中接受治疗的患者（n=87）有三种既往治疗方案的中位数，55.2%为三级难治性。RP2D最常见的不良事件是最佳矫正视力下降（71.1%）、角膜病变（65.8%）、疲劳（57.9%）、感染（47.4%）；7.9%（≥3级），中性粒细胞减少（39.5%），血小板减少（39.5%）。对于RP2D患者（n=38），在中位随访13.9个月时，总缓解率为85.3%，≥非常好的部分缓解率为75.7%，估计的2年无进展生存率为52.8%（95%可信区间，33.9%至82.4%）。RP2D方案与可控制的抗体-药物结合物相关的角膜不良事件相关，并在不影响疗效的情况下改善耐受性。Belantamab mafodotin联合泊马度胺和地塞米松在复发性多发性骨髓瘤中诱导了持久的反应，总生存率有希望，其结果尚未在3期DREAMM-8研究中得到证实。ClinicalTrials.gov标识符：NCT03715478。

英文原文如下：

Abstracts

Due to evolving treatment standards for newly diagnosed multiple myeloma, many patients will be triple-class exposed after initial relapses and have poor survival. Novel therapies and combinations are therefore required to improve outcomes. B cell maturation antigen (BCMA)-targeted biologics have emerged as an important new area of therapeutics for relapsed multiple myeloma. The two-part ALGONQUIN trial evaluated various doses and schedules of the anti-BCMA antibody-drug conjugate belantamab mafodotin plus pomalidomide and dexamethasone for patients who are lenalidomide refractory and proteosome inhibitor exposed. The primary endpoints, including evaluating dose-limiting toxicities, establishing the recommended Part 2 dose (RP2D) and overall response rate for patients treated at the RP2D, were met. Secondary efficacy endpoints included progression-free survival and overall survival. Patients treated on study (N = 87) had a median of three previous regimens and 55.2% were triple-class refractory. At the RP2D the most common adverse events were decrease in best-corrected visual acuity (71.1%), keratopathy (65.8%), fatigue (57.9%), infection (47.4%; 7.9% grade ≥3), neutropenia (39.5%) and thrombocytopenia (39.5%). For RP2D patients (n = 38), the overall response rate was 85.3%, ≥very good partial response 75.7% and estimated two-year progression-free survival 52.8% (95% confidence interval, 33.9% to 82.4%), at a median follow-up of 13.9 months. The RP2D schedule was associated with manageable antibody-drug conjugate-associated corneal adverse events and improved tolerability without compromising efficacy. Belantamab mafodotin plus pomalidomide and dexamethasone induced durable responses with promising overall survival in relapsed multiple myeloma, the results of which are yet to be confirmed in the phase 3 DREAMM-8 study. ClinicalTrials.gov Identifier: NCT03715478 .

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