复发/难治性多发性骨髓瘤（RRMM）患者需要高尚的治疗。尤西里汉-玛氟酮（尤塞慢），一种首创的、针对B细胞成熟抗原结合的抗体药物偶联物，通过直接杀伤细胞和抗骨髓瘤免疫反应消除骨髓瘤细胞。DREAMM-2（NCT03525678）是一项2期、两组、开放标签试验，针对重度预处理的RRMM患者，即前治疗次数≥3次，对调免疫治疗药物和蛋白酶抑制剂耐药，对一种抗CD38单克隆抗体耐受或耐药。尤塞慢以2.5或3.4mg/kg每3周给予。主要终点为整体反应率（ORR），次要终点包括无进展生存期（PFS）、总生存期（OS）、安全性、眼症状和与健康相关的生活质量（HRQOL）。这次最终分析（截至日期2022年3月31日），N=223，中位随访时间分别为12.5和13.8个月，在2.5和3.4mg/kg队列中示出了32%和35%的ORR，2.8和3.9个月的中位PFS，15.3和14.0个月的中位OS。反应持续时间中位数分别为12.5和6.2个月。没有观察到新的安全信号；最常见的3级和4级不良事件是角膜病变（29% vs. 25%）、血小板减少症（22% vs. 29%）和贫血（21% vs. 28%）。HRQOL结果表明，在治疗期间，整体全球健康状况/生活质量、身体和角色功能以及整体疾病症状保持或改善。DREAMM-2的这项最终分析确认了在三类耐药性RRMM患者中，单一药物尤塞慢具有持久且临床意义重大的应答并具有管理可控的安全性。 © 2023 GSK和作者。《癌症》由Wiley Periodicals LLC代表美国癌症协会出版。

Patients with relapsed/refractory multiple myeloma (RRMM) have a high unmet treatment need. Belantamab mafodotin (belamaf), a first-in-class, B-cell maturation antigen-binding antibody-drug conjugate, eliminates myeloma cells through direct cell killing and an anti-myeloma immune response.DREAMM-2 (NCT03525678) was a phase 2, two-arm, open-label trial in patients with heavily pretreated RRMM who had three or more prior therapies, were refractory to an immunomodulatory agent and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 monoclonal antibody. Belamaf was given at 2.5 or 3.4 mg/kg every 3 weeks. The primary end point was overall response rate (ORR); secondary end points included progression-free survival (PFS), overall survival (OS), safety, ocular symptoms, and health-related quality of life (HRQOL).This final analysis (cutoff date, March 31, 2022), N = 223, with median follow-up of 12.5 and 13.8 months, demonstrated an ORR of 32% and 35%, median PFS of 2.8 and 3.9 months, and median OS of 15.3 and 14.0 months in the 2.5 mg/kg and 3.4 mg/kg cohorts, respectively. Median duration of response was 12.5 and 6.2 months. No new safety signals were observed; the most common Grade 3 and 4 adverse events were keratopathy (29% vs. 25%), thrombocytopenia (22% vs. 29%), and anemia (21% vs. 28%). HRQOL outcomes suggest that overall global health status/quality of life, physical and role functioning, and overall disease symptoms were maintained or improved during treatment.This final analysis of DREAMM-2 confirms that in patients with triple-class refractory RRMM, single-agent belamaf results in durable and clinically meaningful responses with a manageable safety profile.© 2023 GSK and The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.