在未经治疗的弥漫性大 B 细胞淋巴瘤 (DLBCL) 患者中，比较 IBI301 生物类似药联合标准 CHOP（I-CHOP）与利妥昔单抗联合 CHOP（R-CHOP）的疗效和安全性：一项随机、双盲、平行组、III 期试验。
Efficacy and Safety of the Biosimilar IBI301 Plus Standard CHOP (I-CHOP) in Comparison With Rituximab Plus CHOP (R-CHOP) in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial.
机构信息
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Lymphoma, Peking University Cancer Hospital and Institute, Beijing, China.
Department of Lymphoma and Hematology, Hunan Province Cancer Hospital, Changsha, China.
出版信息
Adv Ther. 2021 Apr;38(4):1889-1903. doi: 10.1007/s12325-020-01603-8. Epub 2021 Mar 9.
INTRODUCTION
Patients with diffuse large B-cell lymphoma (DLBCL) have limited access to rituximab. IBI301 is a recombinant chimeric murine/human anti-CD20 monoclonal antibody and is a candidate biosimilar to rituximab. This study aimed to assess the therapeutic equivalence of IBI301 and rituximab in previously untreated patients with diffuse large B-cell lymphoma (DLBCL).
METHODS
This multicenter, randomized, double-blind, parallel-group, phase 3 trial compared IBI301 and rituximab, both plus the chemotherapy of doxorubicin, cyclophosphamide, vindesine, and prednisone (CHOP), was conducted in 68 centers across China. Eligible patients with untreated CD20 positive (CD20) DLBCL randomly received IBI301 (375 mg/m) plus the standard CHOP or rituximab (375 mg/m) plus the standard CHOP for six cycles of a 21-day cycle. The primary end point was the overall remission rate (ORR). Efficacy equivalence was defined if 95% CIs for the ORR difference between the two groups were within a ± 12.0% margin.
RESULTS
Between August 22, 2016, and September 5, 2018, 419 patients were randomly allocated into the IBI301 group (N = 209) and rituximab group (N = 210). In the full analysis set, the ORR was 89.9% and 93.8% in the IBI301 and rituximab groups, respectively, and the ORR difference was -3.9% (95% CI - 9.1%-1.3%), falling within a ± 12.0% margin. The occurrences of treatment-emergent adverse events (TEAEs) (100% vs. 99.0%) and AEs of grade ≥ 3 (87.1% vs. 83.3%) were similar in the two groups (P > 0.05).
CONCLUSIONS
IBI301 had a non-inferiority efficacy and a comparable safety compared with rituximab. IBI301 plus CHOP could be suggested as a candidate treatment regimen for untreated patients with CD20 DLBCL.
TRIAL REGISTRATION
This trial is registered on ClinicalTrials.gov (NCT02867566).
简介
患有弥漫性大 B 细胞淋巴瘤（DLBCL）的患者获得利妥昔单抗的机会有限。IBI301 是一种重组嵌合鼠/人抗 CD20 单克隆抗体，是利妥昔单抗的候选生物类似药。本研究旨在评估 IBI301 与利妥昔单抗在未经治疗的弥漫性大 B 细胞淋巴瘤（DLBCL）患者中的治疗等效性。
方法
这是一项多中心、随机、双盲、平行组、III 期临床试验，比较了 IBI301 和利妥昔单抗，两者均联合多柔比星、环磷酰胺、长春新碱和泼尼松（CHOP）化疗，在中国 68 个中心进行。入组未经治疗的 CD20 阳性（CD20）DLBCL 患者随机接受 IBI301（375mg/m）加标准 CHOP 或利妥昔单抗（375mg/m）加标准 CHOP 治疗 6 个 21 天周期。主要终点是总缓解率（ORR）。如果两组间 ORR 差异的 95%CI 在 ±12.0%的范围内，则定义为疗效等效。
结果
2016 年 8 月 22 日至 2018 年 9 月 5 日，419 例患者被随机分配至 IBI301 组（n=209）和利妥昔单抗组（n=210）。在全分析集，IBI301 组和利妥昔单抗组的 ORR 分别为 89.9%和 93.8%，ORR 差异为-3.9%（95%CI-9.1%~1.3%），落在±12.0%的范围内。两组的治疗后发生的不良事件（TEAEs）发生率（100% vs. 99.0%）和≥3 级不良事件（AE）发生率（87.1% vs. 83.3%）相似（P＞0.05）。
结论
与利妥昔单抗相比，IBI301 具有非劣效的疗效和相当的安全性。IBI301 联合 CHOP 可作为未经治疗的 CD20 DLBCL 患者的候选治疗方案。
试验注册
本研究在 ClinicalTrials.gov 注册（NCT02867566）。
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