Single-agent belantamab mafodotin for relapsed/refractory multiple myeloma: analysis of the lyophilised presentation cohort from the pivotal DREAMM-2 study.
Single-agent belantamab mafodotin for relapsed/refractory multiple myeloma: analysis of the lyophilised presentation cohort from the pivotal DREAMM-2 study.
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DOI：
10.1038/s41408-020-00369-0
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发表时间：
2020-10-23
影响因子：
12.8
通讯作者：
Lonial S
中科院分区：
文献类型：
--
作者：
Richardson PG;Lee HC;Abdallah AO;Cohen AD;Kapoor P;Voorhees PM;Hoos A;Wang K;Baron J;Piontek T;Byrne J;Richmond S;Jewell RC;Opalinska J;Gupta I;Lonial S
DREAMM-2（NCT 03525678）是一项正在复发性/难治性多发性骨髓瘤（RRMM）患者中进行的单药belantamab mafodotin（belamaf; GSK 2857916）（一种B细胞成熟抗原靶向抗体-药物偶联物）冷冻液体给药的全球、开放标签、II期研究。除了主研究之外，按照相同的入选/排除标准，还招募了一个单独的患者队列，接受冻干形式的贝拉马夫（3.4 mg/kg，每3周一次），直至疾病进展/不可接受的毒性。主要结局是独立审查委员会评估的总体缓解率（ORR）。入组了25例患者; 24例患者接受了≥1剂Belamaf。截至2020年1月31日，ORR为52%（95% CI：31.3-72.2）; 24%的患者达到非常好的部分缓解。中位缓解持续时间为9.0个月（2.8-未达到[NR]）;中位无进展生存期为5.7个月（2.2-9.7）;未达到中位总生存期（8.7个月-NR）。最常见的3/4级不良事件为角膜病变（微囊样角膜上皮变化，眼科检查中观察到的病理学结果[75%]）、血小板减少症（21%）、贫血（17%）、高钙血症和低磷血症（均为13%）、中性粒细胞减少症和视力模糊（均为8%）。药代动力学支持冷冻液体和冻干制剂的可比性。冻干形式的单药belamaf（预期用于未来使用）在重度预治疗RRMM患者中显示出深度和持久的临床应答以及可接受的安全性特征。
DREAMM-2 (NCT03525678) is an ongoing global, open-label, phase 2 study of single-agent belantamab mafodotin (belamaf; GSK2857916), a B-cell maturation antigen-targeting antibody-drug conjugate, in a frozen-liquid presentation in patients with relapsed/refractory multiple myeloma (RRMM). Alongside the main study, following identical inclusion/exclusion criteria, a separate patient cohort was enrolled to receive belamaf in a lyophilised presentation (3.4 mg/kg, every 3 weeks) until disease progression/unacceptable toxicity. Primary outcome was independent review committee-assessed overall response rate (ORR). Twenty-five patients were enrolled; 24 received ≥1 dose of belamaf. As of 31 January 2020, ORR was 52% (95% CI: 31.3–72.2); 24% of patients achieved very good partial response. Median duration of response was 9.0 months (2.8–not reached [NR]); median progression-free survival was 5.7 months (2.2–9.7); median overall survival was not reached (8.7 months–NR). Most common grade 3/4 adverse events were keratopathy (microcyst-like corneal epithelial changes, a pathological finding seen on eye examination [75%]), thrombocytopenia (21%), anaemia (17%), hypercalcaemia and hypophosphatemia (both 13%), neutropenia and blurred vision (both 8%). Pharmacokinetics supported comparability of frozen-liquid and lyophilised presentations. Single-agent belamaf in a lyophilised presentation (intended for future use) showed a deep and durable clinical response and acceptable safety profile in patients with heavily pre-treated RRMM.
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影响因子：
6.5
作者：
Yong K;Delforge M;Driessen C;Fink L;Flinois A;Gonzalez-McQuire S;Safaei R;Karlin L;Mateos MV;Raab MS;Schoen P;Cavo M
通讯作者：
Cavo M
DOI：
10.1084/jem.20031330
发表时间：
2004-01-05
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
O'Connor BP;Raman VS;Erickson LD;Cook WJ;Weaver LK;Ahonen C;Lin LL;Mantchev GT;Bram RJ;Noelle RJ
通讯作者：
Noelle RJ
影响因子：
11.4
作者：
Gandhi, Ujjawal H.;Cornell, Robert F.;Costa, Luciano J.
通讯作者：
Costa, Luciano J.
影响因子：
3.1
作者：
Pick, Marjorie;Vainstein, Vladimir;Gatt, Moshe E.
通讯作者：
Gatt, Moshe E.
影响因子：
158.5
作者：
Chari, Ajai;Vogl, Dan T.;Jagannath, Sundar
通讯作者：
Jagannath, Sundar