DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma.
DREAMM-2: Indirect Comparisons of Belantamab Mafodotin vs. Selinexor + Dexamethasone and Standard of Care Treatments in Relapsed/Refractory Multiple Myeloma.
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DOI：
10.1007/s12325-021-01884-7
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发表时间：
2021-11
影响因子：
3.8
通讯作者：
Kapetanakis V
中科院分区：
文献类型：
--
作者：
Prawitz T;Popat R;Suvannasankha A;Sarri G;Hughes R;Wang F;Hogea C;Ferrante SA;Gorsh B;Willson J;Kapetanakis V
单药belantamab mafodotin（belamaf; BLENREP）在复发性/难治性多发性骨髓瘤和≥ 3线既往治疗（包括免疫调节剂、蛋白酶体抑制剂和抗CD 38抗体）患者中显示出深度和持久的缓解（DREAMM-2; NCT 03525678）。在本研究时，STORM第2部分，NCT 02336815（selinexor加低剂量地塞米松; sel + dex）被系统性确定为DREAMM-2队列的唯一可行对照药物。匹配调整的间接比较（MAIC）评价了belamaf（2.5 mg/kg; n = 97）与sel + dex（分别为80 mg + 20 mg; n = 123）的疗效和安全性。对人群进行临床验证的效应调节因子和预后因素的加权。结局包括总生存期（OS）、无进展生存期（PFS）、缓解持续时间（DoR）、总缓解率（ORR）、至缓解时间（TTR）和安全性。通过布赫间接治疗比较，使用经MAIC校正的belamaf（DREAMM-2）与sel + dex（STORM第2部分）OS风险比（HR）以及经卡非佐米难治性和sel + dex（STORM）与SoC（猛犸）高危细胞遗传学校正的HR，估计belamaf与标准治疗（SoC）对OS的相对疗效。与sel + dex相比，Belamaf显示OS（HR 0.53; 95%置信区间0.34，0.83; p = 0.005）和DoR（0.41; 0.21，0.83; p = 0.013）改善。ORR、TTR和PFS无统计学显著性差异。与sel + dex相比，Belamaf在大多数可评价的血液学（任何级别，3-4级）和非血液学（任何级别）不良事件方面具有有利的安全性特征。与SoC相比，观察到Belamaf显著改善OS（0.29; 0.16，0.54; p < 0.001）。单药belamaf代表了三重难治性RRMM患者的新治疗选择。在线版本包含补充材料，可通过10.1007/s12325-021-01884-7获得。
Single-agent belantamab mafodotin (belamaf; BLENREP) demonstrated deep and durable responses in patients with relapsed/refractory multiple myeloma and ≥ 3 prior lines of therapy, including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody (DREAMM-2; NCT03525678). At the time of this study, STORM Part 2, NCT02336815 (selinexor plus low-dose dexamethasone; sel + dex) was systematically identified as the only feasible comparator to the DREAMM-2 cohort. Matching-adjusted indirect comparisons (MAIC) evaluated efficacy and safety of belamaf (2.5 mg/kg; n = 97) versus sel + dex (80 mg + 20 mg, respectively; n = 123). Populations were weighted for clinically validated effect modifiers and prognostic factors. Outcomes included overall survival (OS), progression-free survival (PFS), duration of response (DoR), overall response rate (ORR), time to response (TTR), and safety. The relative efficacy of belamaf versus standard of care (SoC) on OS was estimated by a Bucher indirect treatment comparison using the MAIC-adjusted hazard ratios (HR) for OS of belamaf (DREAMM-2) versus sel + dex (STORM Part 2) and a HR adjusted for refractoriness to carfilzomib and high-risk cytogenetics of sel + dex (STORM) versus SoC (MAMMOTH). Belamaf demonstrated improved OS (HR 0.53; 95% confidence interval 0.34, 0.83; p = 0.005) and DoR (0.41; 0.21, 0.83; p = 0.013) versus sel + dex. There were no statistically significant differences in ORR, TTR, and PFS. Belamaf had a favorable safety profile for most evaluable hematologic (any-grade, Grade 3–4) and non-hematologic (any-grade) adverse events versus sel + dex. Significantly improved OS was observed with belamaf versus SoC (0.29; 0.16, 0.54; p < 0.001). Single-agent belamaf represents a new treatment option for triple-class refractory patients with RRMM. The online version contains supplementary material available at 10.1007/s12325-021-01884-7.
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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
影响因子：
11.4
作者：
Gandhi, Ujjawal H.;Cornell, Robert F.;Costa, Luciano J.
通讯作者：
Costa, Luciano J.
多发性骨髓瘤：诊断和治疗。
影响因子：
8.9
作者：
Rajkumar SV;Kumar S
通讯作者：
Kumar S
影响因子：
4
作者：
Gastanaga, Victor M.;Schwartzberg, Lee S.;Liede, Alexander
通讯作者：
Liede, Alexander
DOI：
10.14694/edbk_159009
发表时间：
2016-01-01
期刊：
American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting
影响因子：
--
作者：
Rajkumar, S Vincent
通讯作者：
Rajkumar, S Vincent