首页> 外文期刊>Drug Design, Development and Therapy >Spotlight on Mogamulizumab-Kpkc for Use in Adults with Relapsed or Refractory Mycosis Fungoides or Sézary Syndrome: Efficacy, Safety, and Patient Selection
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Spotlight on Mogamulizumab-Kpkc for Use in Adults with Relapsed or Refractory Mycosis Fungoides or Sézary Syndrome: Efficacy, Safety, and Patient Selection

机译:聚光灯在Mogamulizumab-kPKC中用于成人复发或难治性肌菌菌菌或Sézary综合征:疗效,安全和患者选择

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Advanced cutaneous T cell lymphomas (CTCL) including mycosis fungoides (MF) and Sézary syndrome (SS) are often difficult to manage once they become resistant to initial systemic treatment. Current systemic treatments usually provide a limited duration of disease control, leaving this an area in desperate need of new treatment options for better long-term control. These conditions often affect the older population where transplantation may not be a feasible option. Recent studies evaluated a novel CCR4 humanized monoclonal antibody, mogamulizumab, in relapsed/refractory MF and SS, which show a meaningful progression free survival (PFS) benefit. In August 2018, mogamulizumab was approved by the FDA for the treatment of patients with relapsed/refractory MF/SS who have failed at least one treatment. Approval was based on the Phase III MAVORIC study comparing mogamulizumab to vorinostat, an FDA approved drug for this indication, in 372 patients. In this trial, mogamulizumab was found to have a superior PFS with a median of 7.7 months compared to 3.1 months in the vorinostat arm, with a hazard ratio of 0.53, p 0.001. Mogamulizumab was well tolerated with the most common AE being infusion-related reactions (32%), drug rash (20%), diarrhea (23%), and fatigue (22%). We reviewed the literature leading to the development and approval of mogamulizumab and suggest which patients may benefit the most from this treatment.
机译:一旦它们对初始全身治疗抵抗,患有蕈类诱导(MF)和Sézary综合征(SS)的先进皮肤T细胞淋巴瘤(CTCL)通常难以管理。目前的全身性治疗通常提供有限的疾病控制持续时间,使这一领域在绝望地需要新的治疗方案,以便更好的长期控制。这些条件往往会影响移植可能不是可行的较旧的群体。最近的研究评估了一种新型CCR4人源化单克隆抗体,术复发/难治性MF和SS,其显示出有意义的进展自由存活(PFS)益处。 2018年8月,Mogamulizumab被FDA批准用于治疗患有至少一次治疗的复发/难治性MF / SS的患者。批准是基于III期Mogamulizumab对Vorinostat的MogaMulizog的研究,FDA批准的这种指示的药物,在372名患者中。在该试验中,发现Mogamulizumab具有7.7个月中位数的优越的PFS,而Vorinostat臂中的3.1个月,危险比为0.53,p <0.001。 Mogamulizumab具有良好的耐受性与输液相关的反应(32%),药疹(20%),腹泻(23%)和疲劳(22%)。我们审查了导致Mogamulizumab的开发和批准的文献,并表明哪些患者可能使这种治疗中的大部分受益。

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