| Title | Comparison of efficacy and safety of ripertamab (SCT400) versus rituximab (Mabthere (R)) in combination with CHOP in patients with previously untreated CD20-positive diffuse large B-cell lymphoma: A randomized, single-blind, phase III clinical trial |
| Authors | Shi, Yuankai Zhang, Qingyuan Hong, Xiaonan Wang, Zhen Gao, Yuhuan Zou, Liqun Cen, Hong Gui, Lin Li, Yufu Feng, Jifeng Wang, Zhao Zhang, Mingzhi Jin, Chuan Zhang, Weihua Hu, Jianda Zheng, Chengyun Zheng, Zhendong Zhang, Liling Chen, Shaoshui Huang, Yunhong Tang, Yun Gao, Yajie Hao, Miaowang Li, Xiaoling Chang, Chunkang Yang, Haiyan Wu, Hui Shen, Lida Ke, Xiaoyan Zhang, Liangming Xi, Yaming Yang, Linhua Xie, Liangzhi Gai, Wenlin Ji, Yanan |
| Affiliation | Chinese Acad Med Sci, Canc Hosp, Natl Clin Res Ctr Canc, Dept Med Oncol,Natl Canc Ctr, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China Peking Union Med Coll, Beijing Key Lab Clin Study Anticancer Mol Targete, Beijing, Peoples R China Harbin Med Univ, Canc Hosp, Dept Med Oncol, Harbin, Heilongjiang, Peoples R China Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, Shanghai, Peoples R China Linyi Canc Hosp, Dept Oncol, Linyi, Shandong, Peoples R China Hebei Med Univ, Hosp 4, Dept Hematol, Shijiazhuang, Hebei, Peoples R China Sichuan Univ, West China Hosp, Dept Med Oncol, Ctr Canc, Chengdu, Sichuan, Peoples R China Guangxi Med Univ, Dept Hematol Oncol, Affiliated Canc Hosp, Nanning, Peoples R China Zhengzhou Univ, Dept Hematol, Affiliated Canc Hosp, Zhengzhou, Henan, Peoples R China Henan Canc Hosp, Zhengzhou, Henan, Peoples R China Jiangsu Canc Hosp, Dept Med Oncol, Nanjing, Jiangsu, Peoples R China Capital Med Univ, Beijing Friendship Hosp, Dept Hematol, Beijing, Peoples R China Zhengzhou Univ, Affiliated Hosp 1, Dept Oncol, Zhengzhou, Henan, Peoples R China Guangzhou Med Univ, Affiliated Canc Hosp & Inst, Dept Med Oncol, Guangzhou, Guangdong, Peoples R China Shanxi Med Univ, Affiliated Hosp 1, Dept Hematol, Taiyuan, Shanxi, Peoples R China Fujian Med Univ, Union Hosp, Dept Hematol, Fuzhou, Fujian, Peoples R China Shandong Univ, Hosp 2, Dept Hematol, Jinan, Shandong, Peoples R China Gen Hosp Northern Theater Command, Dept Med Oncol, Shenyang, Liaoning, Peoples R China Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Dept Lymphoma,Canc Ctr, Wuhan, Hubei, Peoples R China Binzhou Med Univ Hosp, Department Oncol, Binzhou, Shandong, Peoples R China Guizhou Med Univ, Affiliated Canc Hosp, Guizhou Canc Hosp, Dept Lymphoma, Guiyang, Guizhou, Peoples R China Sichuan Univ, West China Hosp, Dept Hematol, Chengdu, Sichuan, Peoples R China Dalian Med Univ, Affiliated Hosp 1, Dept Oncol, Dalian, Liaoning, Peoples R China Air Force Med Univ, Tangdu Hosp, Dept Hematol, Xian, Shaanxi, Peoples R China Liaoning Canc Hosp & Inst, Dept Med Oncol, Shenyang, Liaoning, Peoples R China Shanghai Jiao Tong Univ, Affiliated Peoples Hosp 6, Dept Hematol, Shanghai, Peoples R China Zhejiang Canc Hosp, Dept Lymphoma, Hangzhou, Zhejiang, Peoples R China Fujian Canc Hosp, Dept Med Oncol, Fuzhou, Fujian, Peoples R China Kunming Med Univ, Yunnan Canc Hosp, Dept Med Oncol, Kunming, Yunnan, Peoples R China Kunming Med Univ, Affiliated Hosp 3, Kunming, Yunnan, Peoples R China Peking Univ, Dept Hematol, Hosp 3, Beijing, Peoples R China Qingdao Univ, Affiliated Yantai Yuhuangding Hosp, Dept Med Oncol, Yantai, Shandong, Peoples R China Lanzhou Univ, Hosp 1, Dept Hematol, Lanzhou, Gansu, Peoples R China Shanxi Med Univ, Hosp 2, Dept Hematol, Taiyuan, Shanxi, Peoples R China Sinocelltech Ltd, Clin Res Ctr, Beijing, Peoples R China |
| Keywords | CHEMOTHERAPY PLUS RITUXIMAB |
| Issue Date | Aug-2022 |
| Publisher | HEMATOLOGICAL ONCOLOGY |
| Abstract | This study compared the efficacy, safety and immunogenicity of ripertamab (SCT400) and rituximab (Mabthera (R)) combined with CHOP as the first-line treatment for Chinese patients with CD20-positive diffuse large B cell lymphoma (DLBCL). This is a randomized, patient-blind, multicenter, active-control, non-inferiority study with parallel design. Patients were randomly (2:1) to receive ripertamab combined with CHOP (S-CHOP) or rituximab (Mabthera (R)) combined with CHOP (R-CHOP) for up to 6 cycles. The primary endpoint was the Independent Review Committee (IRC) assessed objective response rate (ORR) in full analysis set (FAS) and the per protocol set (PPS). A total of 364 patients (243 in the S-CHOP and 121 in the R-CHOP groups) were enrolled in this study. In FAS, IRC-assessed ORRs were 93.8% (95% confidence interval (CI) 90.0%, 96.5%) and 94.2% (95% CI: 88.4%, 97.6%) in the S-CHOP and R-CHOP groups (p = 0.9633), respectively. The ORR difference between the two groups -0.4% (95% CI: -5.5%, 4.8%) met the prespecified non-inferiority margin of -12%. There were no significant differences between the S-CHOP and R-CHOP groups in 1-year progression-free survival rates (81.1% vs. 83.2%, p = 0.8283), 1 year event-free survival rates (56.2% vs. 58.1%, p = 0.8005), and 3-year overall survival rates (81.0% vs. 82.8%, p = 0.7183). The results in PPS were consistent with those in FAS. The rates of treatment-emergent adverse events (TEAEs) and >= grade 3 TEAEs were 97.9% and 99.2%, 85.2% and 86.0% in the S-CHOP and R-CHOP groups, respectively in safety set. The percentage of anti-drug antibodies positive patients in the S-CHOP group was numerically lower than the R-CHOP group (10.9% vs. 16.0%). This study demonstrated that S-CHOP was not inferior to R-CHOP in the first-line treatment of Chinese patients with CD20-positive DLBCL in efficacy, safety and immunogenecity. S-CHOP could be an alternative first-line standard treatment regimen for this patient population. |
| URI | http://hdl.handle.net/20.500.11897/650461 |
| ISSN | 0278-0232 |
| DOI | 10.1002/hon.3054 |
| Indexed | SCI(E) |
| Appears in Collections: | 第三医院 |
