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Daratumumab, Bortezomib, and Dexamethasone versus Bortezomib and Dexamethasone in Chinese Patients With Relapsed or Refractory Multiple Myeloma: Updated Analysis of LEPUS

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机构： [1]Department of Hematology, Shanghai Fourth People’s Hospital, School of Medicine, Tongji University, Shanghai, China [2]Department of Hematology, Changzheng Hospital, Shanghai, China [3]The First Hospital of Jilin University, Jilin, China [4]Fujian Provincial Key Laboratory of Hematology, Fujian Medical University Union Hospital, Fujian Institute of Hematology, Fujian, China [5]State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union MedicalCollege, Tianjin, China [6]Department of Hematology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention andTherapy, Tianjin’s Clinical Research Center for Cancer, Tianjin, China [7]The First Affiliated Hospital of Soochow University, Suzhou, China [8]The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanzing, China [9]The First Affiliated Hospital of Zhejiang University, College of Medicine, Hangzhou, China [10]Peking University First Hospital, Beijing, China [11]Department of Hematology, Zhongda Hospital Southeast University, Nanzing „ China [12]Department of Hematology, West China Hospital Sichuan University, Chengdu, China [13]Janssen Research & Development, LLC, Spring House, Lower Gwynedd Township, PA, [14]Janssen Research & Development, LLC, Beijing, China [15]Janssen Research & Development, LLC, Shanghai, China [16]Peking University People’s Hospital, National Clinical Research Center for Hematologic Disease, Beijing, China [17]Collaborative Innovation Center of Hematology, Soochow, China

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关键词： CD38 monoclonal antibody efficacy safety Asian

摘要：

In the phase 3 LEPUS study, daratumumab, bortezomib, and dexamethasone (D-Vd) demonstrated significant clinical benefit versus Vd alone in Chinese patients with relapsed or refractory multiple myeloma (RRMM). Here, we report updated efficacy and safety results from LEPUS.Chinese patients with ≥ 1 prior line of therapy were randomized 2:1 to bortezomib (1.3 mg/m2) and dexamethasone (20 mg) for eight cycles ± daratumumab (16 mg/kg) until disease progression. The primary endpoint was progression-free survival (PFS).In total, 211 patients were randomized to D-Vd (n = 141) or Vd (n = 70). At a 25.1-month median follow-up, D-Vd prolonged PFS versus Vd (median, 14.8 vs. 6.3 months; hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.24-0.51; P < .00001). PFS benefit of D-Vd versus Vd was maintained across prespecified subgroups, including patients with prior bortezomib (HR, 0.36; 95% CI, 0.25-0.53), patients who were refractory to last prior line of therapy (HR, 0.42; 95% CI, 0.27-0.65), and patients with high-risk cytogenetics (HR, 0.41; 95% CI, 0.23-0.71). Overall response rate (84.7% vs.66.7%; P = .00314) and rates of very good partial response or better (71.5% vs. 34.9%; P < .00001) and complete response or better (40.1% vs 14.3%; P = .00016) were higher with D-Vd versus Vd. No new safety concerns were identified.In this updated analysis, D-Vd maintained significant efficacy benefits versus Vd alone and demonstrated a consistent safety profile, further supporting the use of D-Vd as a standard of care in Chinese patients with RRMM.Copyright © 2022 Janssen Research & Development, LLC. Published by Elsevier Inc. All rights reserved.

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出版当年[2022]版：

大类 | 4 区医学

小类 | 4 区血液学 4 区肿瘤学

最新[2023]版：

大类 | 4 区医学

小类 | 4 区血液学 4 区肿瘤学

第一作者：

第一作者机构： [1]Department of Hematology, Shanghai Fourth People’s Hospital, School of Medicine, Tongji University, Shanghai, China [2]Department of Hematology, Changzheng Hospital, Shanghai, China

通讯作者：

通讯机构： [16]Peking University People’s Hospital, National Clinical Research Center for Hematologic Disease, Beijing, China [17]Collaborative Innovation Center of Hematology, Soochow, China [*1]Peking University People’s Hospital, National Clinical Research Center for Hematologic Disease, Collaborative Innovation Center of Hematology,No. 11 Xizhimen South Street, 100044, Beijing, China

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Daratumumab, Bortezomib, and Dexamethasone versus Bortezomib and Dexamethasone in Chinese Patients With Relapsed or Refractory Multiple Myeloma: Updated Analysis of LEPUS

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