Abstract: 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.

Keywords: CTCL, mycosis fungoides, Sézary syndrome, mogamulizumab, T cell lymphoma, CCR4


中文翻译：

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Mogamulizumab-Kpkc聚焦于患有复发性或难治性蕈样肉芽肿或塞氏病综合症的成年人：疗效，安全性和患者选择

摘要：晚期皮肤T细胞淋巴瘤（CTCL），包括真菌病（MF）和塞萨里综合征（SS），一旦对初始全身治疗产生耐药性，通常就很难治疗。当前的全身治疗通常提供有限的疾病控制持续时间，这使得迫切需要新的治疗选择以更好地长期控制的领域。这些条件通常会影响老年人口，在这些人群中移植可能不是可行的选择。最近的研究在复发/难治性MF和SS中评估了一种新型CCR4人源化单克隆抗体mogamulizumab，它显示了有意义的无进展生存（PFS）益处。2018年8月，mogamulizumab被FDA批准用于治疗至少一种治疗无效的复发/难治性MF / SS患者。批准的依据是在372例患者中比较了莫加莫珠单抗和FDA批准的用于此适应症的伏立诺司特伏格列单抗的III期MAVORIC研究。在该试验中，发现莫加莫珠单抗具有较好的PFS，中位值为7.7个月，而伏立诺他组为3.1个月，危险比为0.53，p <0.001。Mogamulizumab的耐受性良好，最常见的AE是与输注相关的反应（32％），皮疹（20％），腹泻（23％）和疲劳（22％）。我们回顾了导致莫加米珠单抗开发和批准的文献，并建议哪些患者可能从这种治疗中受益最大。危险比为0.53，p <0.001。Mogamulizumab的耐受性良好，最常见的AE是与输注相关的反应（32％），皮疹（20％），腹泻（23％）和疲劳（22％）。我们回顾了导致莫加米珠单抗开发和批准的文献，并建议哪些患者可能从这种治疗中受益最大。危险比为0.53，p <0.001。Mogamulizumab的耐受性良好，最常见的AE是与输注相关的反应（32％），皮疹（20％），腹泻（23％）和疲劳（22％）。我们回顾了导致莫加米珠单抗开发和批准的文献，并建议哪些患者可能从这种治疗中受益最大。

关键词： CTCL，真菌病，蕈样肉芽肿，塞氏病，莫加单抗，T细胞淋巴瘤，CCR4