利妥昔单抗（SCT400）与利妥昔单抗（美罗华）联合CHOP方案治疗初治CD20阳性弥漫性大B细胞淋巴瘤患者的疗效和安全性比较：一项随机、单盲、III期临床试验
Comparison of efficacy and safety of ripertamab (SCT400) versus rituximab (Mabthera ) in combination with CHOP in patients with previously untreated CD20-positive diffuse large B-cell lymphoma: A randomized, single-blind, phase III clinical trial.
作者信息
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
机构信息
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.
Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.
出版信息
Hematol Oncol. 2022 Dec;40(5):930-940. doi: 10.1002/hon.3054. Epub 2022 Aug 12.
This study compared the efficacy, safety and immunogenicity of ripertamab (SCT400) and rituximab (Mabthera ) 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 ) 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 pre-specified 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.
本研究比较了利妥昔单抗（SCT400）与利妥昔单抗（美罗华）联合CHOP方案作为中国CD20阳性弥漫性大B细胞淋巴瘤（DLBCL）患者一线治疗的疗效、安全性和免疫原性。这是一项随机、患者盲法、多中心、活性对照、非劣效性平行设计研究。患者按2:1随机分组，接受利妥昔单抗联合CHOP方案（S-CHOP）或利妥昔单抗（美罗华）联合CHOP方案（R-CHOP）治疗，最多6个周期。主要终点是独立审查委员会（IRC）在全分析集（FAS）和符合方案集（PPS）中评估的客观缓解率（ORR）。本研究共纳入364例患者（S-CHOP组243例，R-CHOP组121例）。在FAS中，S-CHOP组和R-CHOP组IRC评估的ORR分别为93.8%（95%置信区间（CI）90.0%，96.5%）和94.2%（95%CI：88.4%，97.6%）（p = 0.9633）。两组之间的ORR差异为-0.4%（95%CI：-5.5%，4.8%），达到预先设定的非劣效性界值-12%。S-CHOP组和R-CHOP组在1年无进展生存率（81.1%对83.2%，p = 0.8283）、1年无事件生存率（56.2%对58.1%，p = 0.8005）和3年总生存率（81.0%对82.8%，p = 0.7183）方面无显著差异。PPS中的结果与FAS中的结果一致。在安全性集里，S-CHOP组和R-CHOP组治疗中出现的不良事件（TEAE）发生率和≥3级TEAE发生率分别为97.9%和99.2%、85.2%和86.0%。S-CHOP组抗药抗体阳性患者的百分比在数值上低于R-CHOP组（10.9%对16.0%）。本研究表明，在疗效、安全性和免疫原性方面，S-CHOP方案在CD20阳性DLBCL中国患者的一线治疗中不劣于R-CHOP方案。S-CHOP方案可作为该患者群体的替代一线标准治疗方案。
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