亚盛医药-B(06855.HK)：APG-115在中国获批一项Ib/II期临床试验
格隆汇 10 月 27日丨亚盛医药-B(06855.HK)发布公告，公司1类新药MDM2-p53抑制剂APG-115获得国家药品监督管理局药物审评中心(CDE)临床许可，将开展联合PD-1/PD-L1抑制剂治疗晚期脂肪肉瘤或其他晚期实体瘤患者的Ib/II期临床研究。
该项研究为针对晚期脂肪肉瘤或其他晚期实体瘤患者进行的全国多中心、开放性、联合治疗的Ib/II期研究，将分成两个阶段进行，Ib期为剂量探索阶段，旨在评估APG-115联合PD-1抑制剂(特瑞普利单抗)的安全性和耐受性；II期为剂量扩增，并在TP53野生型且MDM2扩增的晚期脂肪肉瘤患者中探索疗效。
脂肪肉瘤(LPS)是软组织肉瘤中常见的组织学类型，约占软组织肉瘤的20%，MDM2扩增在脂肪肉瘤中常见，同时脂肪肉瘤患者TP53为野生型者约占一半。手术切除是当前脂肪肉瘤治疗的主要手段，也推荐术前、术后化疗加或不加放疗。晚期复发或转移性中LPS患者也可接受全身化疗。然而根据目前的数据晚期脂肪肉瘤在化疗中的获益极小，超过80%的脂肪肉瘤病例均会复发。目前可用于脂肪肉瘤的靶向治疗及免疫治疗的药物及疗效均非常有限。因此，全面了解脂肪肉瘤的病理特点，探索并开发新型、有效的针对脂肪肉瘤的联合治疗方案，是亟待解决的临床问题。
APG-115是亚盛医药自主研发的一种口服生物可利用的、高选择性的小分子MDM2抑制剂。APG-115对MDM2具有高度结合亲和力，通过阻断MDM2-p53蛋白质间相互作用从而恢复p53肿瘤抑制活性。APG-115是首个在中国进入临床阶段的MDM2-p53抑制剂，已在中国和美国展开多项治疗实体瘤及血液肿瘤的临床研究。值得关注的是，APG-115在中国单药治疗晚期脂肪肉瘤的临床研究中已显示出积极的抗肿瘤效果。一例部分缓解(PR)患者停药后观察到的超过10个月的持续缓解，显示APG-115可能具有宿主免疫调节作用，也为进一步评价APG-115单药治疗或与免疫治疗联合治疗提供了基础。
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