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Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study.

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机构： [1]Peking University People’s Hospital, National Clinical Research Center for Hematologic Disease, Beijing, China [2]Collaborative Innovation Center of Hematology, Soochow, China [3]Shanghai Changzheng Hospital, Shanghai, China [4]The First Hospital of Jilin University, Jilin, China [5]Fujian Medical University Union Hospital, Fujian Institute of Hematology, Fujian Provincial Key Laboratory of Hematology, Fujian, China [6]Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China [7]Tianjin Cancer Hospital, Tianjin, China [8]The First Affiliated Hospital of Soochow University, Jiangsu, China [9]The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Jiangsu, China [10]The First Affiliated Hospital of Zhejiang University, College of Medicine, Zhejiang, China [11]Peking University First Hospital, Beijing, China [12]Zhongda Hospital Southeast University, Jiangsu, China [13]West China Hospital Sichuan University, Sichuan, China [14]Janssen Research & Development, Spring House, PA, USA [15]Janssen Research & Development, Raritan, NJ, USA [16]Janssen Research & Development, Beijing, China [17]Janssen Research & Development, Shanghai, China

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Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the phase 3 CASTOR study. We report the results of a prespecified interim analysis of the phase 3 LEPUS study of D-Vd versus Vd in Chinese patients with RRMM.Chinese patients with ≥ 1 prior line of therapy were randomized 2:1 to receive 8 cycles (21 days/cycle) of bortezomib (1.3 mg/m2 subcutaneously) and dexamethasone (20 mg orally/intravenously) ± daratumumab (16 mg/kg intravenously). The primary endpoint was progression-free survival (PFS).A total of 211 patients were randomized (D-Vd, 141; Vd, 70). After an 8.2-month median follow-up, D-Vd significantly prolonged PFS versus Vd (median, not reached vs. 6.3 months; hazard ratio, 0.28; 95% confidence interval, 0.17-0.47; P < .00001) and significantly improved the rates of overall response (83% vs. 65%; P = .00527), ≥ very good partial response (65% vs. 33%; P = .00002), ≥ complete response (33% vs. 11%; P = .00079), and minimal residual disease negativity (10-5 sensitivity; 22% vs. 3%; P = .0002). The PFS benefit of D-Vd versus Vd was maintained across prespecified subgroups, including patients with prior bortezomib treatment and with high-risk cytogenetics. Thrombocytopenia (D-Vd, 51%; Vd, 37%), lymphopenia (44%; 29%), and lung infection (30%; 22%) were the 3 most common grade 3/4 treatment-emergent adverse events. Although patients in both treatment groups experienced higher rates of grade 3/4 lymphopenia and infections versus patients in CASTOR, the safety profile was generally consistent with that of CASTOR.These data support the use of D-Vd in Chinese patients with RRMM.Copyright © 2021 Janssen Research & Development, LLC. Published by Elsevier Inc. All rights reserved.

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出版当年[2021]版：

大类 | 4 区医学

小类 | 4 区肿瘤学 4 区血液学

最新[2023]版：

大类 | 4 区医学

小类 | 4 区血液学 4 区肿瘤学

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出版当年[2021]版：

Q3 HEMATOLOGY Q4 ONCOLOGY

最新[2023]版：

Q2 HEMATOLOGY Q3 ONCOLOGY

影响因子： 2.7 最新[2023版] 2.4 最新五年平均 2.822 出版当年[2021版] 2.645 出版当年五年平均 3.231 出版前一年[2020版] 2.7 出版后一年[2022版]

第一作者：

第一作者机构： [1]Peking University People’s Hospital, National Clinical Research Center for Hematologic Disease, Beijing, China [2]Collaborative Innovation Center of Hematology, Soochow, China

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通讯作者：

通讯机构： [1]Peking University People’s Hospital, National Clinical Research Center for Hematologic Disease, Beijing, China [2]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, Xizhimen South Street, 100000, Beijing, China.

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