| Title | Daratumumab, Bortezomib, and Dexamethasone versus Bortezomib and Dexamethasone in Chinese Patients With Relapsed or Refractory of LEPUS |
| Authors | 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 Gai, Xue Li, Qian Liu, Weiping Liu, Wenyu Yang, Xue Chen, Xi Lu, Jin |
| Affiliation | Tongji Univ, Shanghai Peoples Hosp 4, Sch Med, Dept Hematol, Shanghai, Peoples R China Changzheng Hosp, Dept Hematol, Shanghai, Peoples R China First Hosp Jilin Univ, Jilin, Peoples R China Fujian Med Univ, Union Hosp, Fujian Inst Hematol, Fujian Prov Key Lab Hematol, Fuzhou, Fujian, Peoples R China Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, State Key Lab Expt Hematol, Tianjin, Peoples R China Tianjin Med Univ, Canc Inst & Hosp, Natl Clin Res Ctr Canc, Tianjins Clin Res Ctr Canc,Dept Hematol,Key Lab Ca, Tianjin, Peoples R China Soochow Univ, Affiliated Hosp 1, Suzhou, Peoples R China Nanjing Med Univ, Affiliated Hosp 1, Jiangsu Prov Hosp, Nanzing, Peoples R China Zhejiang Univ, Affiliated Hosp 1, Coll Med, Hangzhou, Peoples R China Peking Univ First Hosp, Beijing, Peoples R China Southeast Univ, Zhongda Hosp, Dept Hematol, Nanzing, Peoples R China Sichuan Univ, West China Hosp, Dept Hematol, Chengdu, Peoples R China Janssen Res & Dev LLC, Lower Gwynedd Township, Spring House, PA USA Janssen Res & Dev LLC, Beijing, Peoples R China Janssen Res & Dev LLC, Shanghai, Peoples R China Peking Univ, Peoples Hosp, Natl Clin Res Ctr Hematol Dis, Beijing, Peoples R China Collaborat Innovat Ctr Hematol, Suzhou, Peoples R China Peking Univ, Peoples Hosp, Natl Clin Res Ctr Hematol Dis, Collaborat Innovat Ctr Hematol, 11 Xizhimen South St, Beijing 100044, Peoples R China |
| Keywords | ANTIBODY DARATUMUMAB OPEN-LABEL |
| Issue Date | Jan-2023 |
| Publisher | CLINICAL LYMPHOMA MYELOMA & LEUKEMIA |
| Abstract | LEPUS showed significant efficacy benefits with daratumumab plus bortezomib/dexamethasone (D-Vd) versus Vd for Chinese patients with relapsed or refractory multiple myeloma (RRMM). With similar to 2 years' median follow-up, D-Vd continued to prolong progression-free survival and achieve higher complete response or better rates with consistent safety, further supporting the use of D-Vd as a standard of care in Chinese patients with RRMM.Background: 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.Patients and Methods: 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 +/- daratu-mumab (16 mg/kg) until disease progression. The primary endpoint was progression-free survival (PFS). Results: 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.Conclusions: In this updated analysis, D-Vd maintained significant efficacy benefits versus Vd alone and demonstrated a consistent safety profile, fur ther suppor ting the use of D-Vd as a standard of care in Chinese patients with RRMM. |
| URI | http://hdl.handle.net/20.500.11897/668056 |
| ISSN | 2152-2650 |
| DOI | 10.1016/j.clml.2022.10.007 |
| Indexed | SCI(E) |
| Appears in Collections: | 第一医院 人民医院 |
