Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study.
Longer term outcomes with single-agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13-month follow-up from the pivotal DREAMM-2 study.
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DOI：
10.1002/cncr.33809
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发表时间：
2021-11-15
期刊：
影响因子：
6.2
通讯作者：
Cohen AD
中科院分区：
文献类型：
--
作者：
Lonial S;Lee HC;Badros A;Trudel S;Nooka AK;Chari A;Abdallah AO;Callander N;Sborov D;Suvannasankha A;Weisel K;Voorhees PM;Womersley L;Baron J;Piontek T;Lewis E;Opalinska J;Gupta I;Cohen AD
基于DREAMM-2研究（ClinicalTrials.gov标识符NCT 03525678），单药belantamab mafodotin（belamaf）获批用于接受≥4种既往治疗（包括抗CD 38治疗）的复发性或难治性多发性骨髓瘤（RRMM）患者。作者研究了DREAMM-2中接受belamaf 2.5 mg/kg治疗的患者在13个月随访后的长期疗效和安全性结局。DREAMM-2是一项正在进行的、II期、开放标签、2组研究，旨在研究belamaf（2.5或3.4 mg/kg）治疗≥3线治疗后疾病进展、免疫调节药物和蛋白酶体抑制剂难治性以及抗CD 38治疗难治性和/或不耐受的RRMM患者。主要结局是由独立审查委员会评估的达到总体缓解的患者比例。截至2020年1月31日，仍有10%的患者接受2.5 mg/kg的Belamaf治疗。97例患者中有31例（32%; 97.5%置信区间[CI]，21.7%-43.6%）达到总体缓解，18例缓解者达到非常好的部分缓解或更好。中位估计缓解持续时间、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）。高风险细胞遗传学或肾损害患者的缓解和生存结局与总体人群的结局一致。髓外疾病患者的结局较差。在有临床反应和延长给药延迟（>63天;主要是由于角膜事件）的患者中，88%在首次延长给药延迟期间维持或加深反应。总体而言，本次随访期间没有出现新的安全信号。延长随访证实了belamaf在这种接受过大量预治疗的RRMM患者人群中的持续临床活性，没有新的安全性信号。正在进行的II期DREAMM-2研究中入组的患者的延长随访证实了复发性或难治性多发性骨髓瘤患者接受belantamab mafodotin 2.5 mg/kg每3周一次的持续临床活性，无新的安全性信号。这些数据表明，belantamab mafodotin有可能改变这种重度预治疗、抗CD 38单克隆抗体暴露的患者人群的治疗模式，该人群预后不良，替代治疗选择很少。
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. Extended follow‐up of patients enrolled in the ongoing phase 2 DREAMM‐2 study confirms sustained clinical activity without new safety signals in patients with relapsed or refractory multiple myeloma who receive belantamab mafodotin 2.5 mg/kg every 3 weeks. These data show that belantamab mafodotin has the potential to shift the treatment paradigm in this heavily pretreated, anti‐CD38 monoclonal antibody–exposed patient population, which has a poor prognosis and few alternative treatment options.
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影响因子：
12.8
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