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首页> 外文期刊>Experimental Hematology Oncology >Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy
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Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy

机译：临床确认，证明生物仿制性PEGFILGRASTIM的相似性：用于拟议的生物仿生蛋白的3路随机性等效研究与接受骨髓抑制化疗的乳腺癌患者的美国许可和欧盟批准的参考产品

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Chemotherapy-induced neutropenia is a common result of myelosuppressive chemotherapy treatment. Infections such as febrile neutropenia (FN) are sensitive to the duration of neutropenia as well as the depth of absolute neutrophil count (ANC) at nadir. Filgrastim, a granulocyte colony stimulating factor (G-CSF), can stimulate the function of mature neutrophils. Pegfilgrastim, a long-acting form of filgrastim, has been shown to reduce FN to a greater extent compared to filgrastim. G-CSF agents have been recommended for prophylactic administration with chemotherapy. Apotex developed a proposed pegfilgrastim biosimilar. This study was conducted to confirm that no clinically meaningful efficacy or safety differences exist between Apotex's proposed biosimilar and its reference product. 589 breast cancer patients were randomized and dosed with the proposed pegfilgrastim biosimilar, US-licensed pegfilgrastim reference product, or EU-approved pegfilgrastim reference product. The primary endpoint assessed was the duration of severe neutropenia (DSN) and secondary endpoints included rate of FN and ANC nadir. Data showed that the mean DSN, the primary endpoint measured, was comparable across all three treatments. The As Treated arm had a 95% confidence interval within the equivalence range for the proposed pegfilgrastim biosimilar with the US-licensed and EU-approved pegfilgrastim reference products. Secondary endpoints, which included depth and peak of ANC nadir, time to ANC recovery post-nadir and rates of FN, also showed similarity between the three different treatment groups. The adverse event incidence was similar across treatment arms and there were no unexpected safety events. Overall, these results show that the proposed pegfilgrastim biosimilar is similar to Amgen's US-licensed and EU-approved pegfilgrastim reference products with regard to the clinical efficacy and safety endpoints assessed.Trial registration EMA: European Union Clinical Trials Register: (https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002678-21) Eudract # 2011-002678-21 Registered: 01/10/2012.
机译：化学疗法诱导的中性粒细胞病是髓抑制化疗治疗的常见结果。感染如发热中性粒细胞贫症（FN）对Nadir的中性粒细胞减少持续时间以及绝对中性粒细胞计数（ANC）的深度敏感。粒细胞菌落刺激因子（G-CSF），可以刺激成熟中性粒细胞的功能。 Pegfilgrastim是一款长效形式的菲拉特，已被证明与菲拉特相比，在更大程度上减少Fn。已经推荐了G-CSF试剂用于化疗的预防施用。 Apotex开发了一个提出的Pegfilgrastim BioSimilar。进行了本研究以确认APOTEX拟议的生物拖递和其参考产品之间存在临床上有意义的疗效或安全差异。 589例乳腺癌患者被拟议的PEGFILGRASTIM BioSimilar，美国授权的PEGFILGRASTIM参考产物或欧盟批准的PEGFILGRASTIM参考产品进行随机化并给药。评估的主要终点是严重的中性粒细胞减少症（DSN）和次要终点的持续时间包括FN和ANC Nadir的率。数据显示，平均DSN，测量的主要终点，在所有三种处理中相当。作为拟议的Pegfilgrastim BioSimilar与美国授权和欧盟批准的PEGFILGRASTIM参考产品的等效范围内的置位范围内具有95％的置信区间。包括ANC Nadir的深度和峰的次要终点，对NADIR后Nadir的时间和Fn的速率，在三种不同治疗组之间也显示出相似性。不良事件发病率在治疗臂中相似，没有意外的安全事件。总体而言，这些结果表明，拟议的PegfilGrastim BioSimilar类似于AMGEN的美国许可和欧盟批准的PEGFILGRASTIM参考产品，关于评估的临床疗效和安全终点.TIAL注册EMA：欧盟临床试验登记册:( HTTPS：// www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002678-21）注册：01/10/2012。

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