背景:RTXM83,利妥昔单抗的生物仿制药,经过物理化学批准,功能,非临床,和临床研究证明了它们的相似性;这些研究包括RTXM83-AC-01-11,这是一项多中心双盲国际前瞻性关键研究。有关生物仿制药的长期数据可能会阐明其临床稳健性并促进其更广泛的采用。
方法:在这项回顾性观察研究中,我们分析了之前在RTXM83-AC-01-11研究中随机分组的巴西队列的数据集,然后评估了从RTXM83-AC-01-11研究中随机分组到最后一次记录评估的观察性延伸阶段的长期结局.弥漫性大B细胞淋巴瘤(DLBCL)患者接受参考利妥昔单抗(R)或RTXM83加环磷酰胺,阿霉素,长春新碱,和泼尼松(CHOP)作为辅助治疗。
结果:中位随访期为77.0个月。初始DLBCLIII和IV期患者占R-CHOP组的50%和生物类似药组的40%。五名(18.5%)患者,包括两名RTXM83-CHOP治疗和三名R-CHOP治疗的患者,经历了感兴趣的晚期不良事件(AE)。没有建立新的安全标志。在最后的评估中,RTXM83-CHOP和R-CHOP组的无进展生存率(PFS)分别为93.3%和50.0%,分别。RTXM83-CHOP组未达到PFS中位数,R-CHOP组为40.5个月。RTXM83-CHOP和R-CHOP组的总生存率分别为100%和66.7%,分别。任何组均未达到中位OS。
结论:这项研究证明了RTXM83治疗DLBCL的长期安全性和有效性;结果与参考产品相当,并可能改善治疗。然而,针对更多不同患者群体的进一步研究可以验证这些发现,并倡导在癌症治疗中更广泛地采用生物仿制药.
背景:ClinicalTrials.gov标识符:NCT04928573。2021年6月16日,“回顾性注册”。
BACKGROUND: RTXM83, a biosimilar of rituximab, was approved after physicochemical, functional, non-clinical, and clinical studies demonstrated their similarity; these studies included RTXM83-AC-01-11, a multicentric double-blind international prospective pivotal
study. Long-term data on biosimilars can potentially elucidate their clinical robustness and facilitate their broader adoption.
METHODS: In this retrospective observational
study, we analyzed a dataset from a Brazilian cohort previously randomized in the RTXM83-AC-01-11
study followed by the assessment of long-term outcomes in an observational extension phase from randomization in the RTXM83-AC-01-11
study to the last recorded evaluation. Patients with diffuse large B cell lymphoma (DLBCL) received either reference rituximab (R) or RTXM83 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) as adjuvant treatment.
RESULTS: The median follow-up period was 77.0 months. Patients with initial DLBCL stages III and IV comprised 50% of the R-CHOP group and 40% of the biosimilar group. Five (18.5%) patients, including two RTXM83-CHOP-treated and three R-CHOP-treated individuals, experienced late adverse events (AEs) of interest. No new safety signs were established. At the final assessment, the progression-free survival (PFS) rates were 93.3% and 50.0% in the RTXM83-CHOP and R-CHOP groups, respectively. Median PFS was not achieved in the RTXM83-CHOP group, which was 40.5 months in the R-CHOP group. The overall survival (OS) rates were 100% and 66.7% in the RTXM83-CHOP and R-CHOP groups, respectively. The median OS was not reached in any group.
CONCLUSIONS: This
study demonstrated the long-term safety and effectiveness of RTXM83 in treating DLBCL; outcomes comparable to those of the reference product and potentially improved access to treatment have been indicated. However, further research with more diverse patient groups can validate these findings and advocate the broader adoption of biosimilars in cancer care.
BACKGROUND: ClinicalTrials.gov Identifier: NCT04928573. June 16, 2021, \"retrospectively registered\".