Winship Cancer Institute, Emory University, Atlanta, Georgia.
Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cancer. 2021 Nov 15;127(22):4198-4212. doi: 10.1002/cncr.33809. Epub 2021 Jul 27.
On the basis of the DREAMM-2 study (ClinicalTrials.gov identifier NCT03525678), single-agent belantamab mafodotin (belamaf) was approved for patients with relapsed or refractory multiple myeloma (RRMM) who received ≥4 prior therapies, including anti-CD38 therapy. The authors investigated longer term efficacy and safety outcomes in DREAMM-2 after 13 months of follow-up among patients who received belamaf 2.5 mg/kg.
DREAMM-2 is an ongoing, phase 2, open-label, 2-arm study investigating belamaf (2.5 or 3.4 mg/kg) in patients with RRMM who had disease progression after ≥3 lines of therapy and were refractory to immunomodulatory drugs and proteasome inhibitors and refractory and/or intolerant to an anti-CD38 therapy. The primary outcome was the proportion of patients that achieved an overall response, assessed by an independent review committee.
As of January 31, 2020, 10% of patients still received belamaf 2.5 mg/kg. Thirty-one of 97 patients (32%; 97.5% confidence interval [CI], 21.7%-43.6%) achieved an overall response, and 18 responders achieved a very good partial response or better. Median estimated duration of response, overall survival, and progression-free survival were 11.0 months (95% CI, 4.2 months to not reached), 13.7 months (95% CI, 9.9 months to not reached), and 2.8 months (95% CI, 1.6-3.6 months), respectively. Response and survival outcomes in patients who had high-risk cytogenetics or renal impairment were consistent with outcomes in the overall population. Outcomes were poorer in patients with extramedullary disease. In patients who had a clinical response and prolonged dose delays (>63 days; mainly because of corneal events), 88% maintained or deepened responses during their first prolonged dose delay. Overall, there were no new safety signals during this follow-up.
Extended follow-up confirms sustained clinical activity without new safety signals with belamaf in this heavily pretreated patient population with RRMM.
基于 DREAMM-2 研究（ClinicalTrials.gov 标识符 NCT03525678），单药贝兰单抗 mafodotin（belamaf）获批用于接受过≥4 种治疗方案的复发或难治性多发性骨髓瘤（RRMM）患者，包括抗 CD38 治疗。作者在 DREAMM-2 研究中，对接受 belamaf 2.5mg/kg 的患者进行了 13 个月的随访，评估了更长时间的疗效和安全性。
DREAMM-2 是一项正在进行的、开放标签、2 臂的研究，评估了 belamaf（2.5 或 3.4mg/kg）在 RRMM 患者中的疗效，这些患者在接受≥3 线治疗后疾病进展，对免疫调节剂和蛋白酶体抑制剂耐药，且对抗 CD38 治疗不耐受或耐药。主要终点是由独立审查委员会评估的总体反应比例。
截至 2020 年 1 月 31 日，仍有 10%的患者接受 belamaf 2.5mg/kg 治疗。97 例患者中有 31 例（32%；97.5%置信区间[CI]，21.7%-43.6%）达到了总体反应，18 名缓解者达到了很好的部分缓解或更好。中位估计反应持续时间、总生存期和无进展生存期分别为 11.0 个月（95%CI，4.2 个月至未达到）、13.7 个月（95%CI，9.9 个月至未达到）和 2.8 个月（95%CI，1.6-3.6 个月）。高危细胞遗传学或肾功能损害患者的反应和生存结局与总体人群的结局一致。骨髓外疾病患者的结局较差。在有临床反应和延长剂量延迟（>63 天；主要是因为角膜事件）的患者中，88%在第一次延长剂量延迟期间维持或加深反应。总的来说，在此随访期间没有新的安全信号。
在 RRMM 这一既往治疗较多的患者群体中，延长随访时间证实了 belamaf 持续的临床活性，且没有新的安全性信号。
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