| Title | Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Chinese Patients with Relapsed or Refractory Multiple Myeloma: Phase 3 LEPUS (MMY3009) Study |
| Authors | Lu, Jin Fu, Weijun Li, Wei Hu, Jianda An, Gang Wang, Yafei Fu, Chengcheng Chen, Lijuan Jin, Jie Cen, Xinan Ge, Zheng Cai, Zhen Niu, Ting Qi, Ming Sun, Steven Gai, Xue Liu, Weiping Liu, Wenyu Yang, Xue Huang, Xiaojun |
| Affiliation | Peking Univ, Natl Clin Res Ctr Hematol Dis, Peoples Hosp, Beijing, Peoples R China Collaborat Innovat Ctr Hematol, Suzhou, Peoples R China Shanghai Changzheng Hosp, Shanghai, Peoples R China First Hosp Jilin Univ, Jilin, Jilin, Peoples R China Fujian Med Univ, Fujian Inst Hematol, Fujian Prov Key Lab Hematol, Union Hosp, Fuzhou, Fujian, Peoples R China Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol, Tianjin, Peoples R China Chinese Acad Med Sci & Peking Union Med Coll, Blood Dis Hosp, Tianjin, Peoples R China Tianjin Canc Hosp, Tianjin, Peoples R China Soochow Univ, Affiliated Hosp 1, Suzhou, Jiangsu, Peoples R China Nanjing Med Univ, Affiliated Hosp 1, Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China Zhejiang Univ, Affiliated Hosp 1, Coll Med, Hangzhou, Zhejiang, Peoples R China Peking Univ First Hosp, Beijing, Peoples R China Southeast Univ, Zhongda Hosp, Nanjing, Jiangsu, Peoples R China Sichuan Univ, West China Hosp, Chengdu, Sichuan, Peoples R China Janssen Res & Dev, Spring House, PA USA Janssen Res & Dev, Raritan, NJ USA Janssen Res & Dev, Beijing, Peoples R China Janssen Res & Dev, Shanghai, Peoples R China |
| Keywords | ANTIBODY DARATUMUMAB LENALIDOMIDE DISEASE |
| Issue Date | Sep-2021 |
| Publisher | CLINICAL LYMPHOMA MYELOMA & LEUKEMIA |
| Abstract | Daratumumab plus bortezomib/dexamethasone (D-Vd) significantly improved outcomes versus Vd in patients with relapsed or refractory multiple myeloma (RRMM) in the global phase 3 CASTOR study. In this phase 3 LEPUS study, among Chinese patients with RRMM (D-Vd, 141 patients; Vd, 70 patients), D-Vd demonstrated significant efficacy benefits versus Vd, and a safety profile generally consistent with that reported in CASTOR. Background: 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. Patients and methods: 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). Results: 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. Conclusion: These data support the use of D-Vd in Chinese patients with RRMM. |
| URI | http://hdl.handle.net/20.500.11897/624071 |
| ISSN | 2152-2650 |
| DOI | 10.1016/j.clml.2021.04.012 |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 第一医院 |
