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亞盛醫藥-B(06855.HK):MDM2-p53抑制劑APG-115(Alrizomadlin)獲FDA孤兒藥認定,治療IIB-IV期黑色素瘤
格隆匯 07-21 18:06

格隆匯7月21日丨亞盛醫藥-B(06855.HK)發佈公告,美國食品和藥品監督管理局(FDA)日前授予公司細胞凋亡管線在研原創新藥MDM2-p53抑制劑APG-115 (Alrizomadlin)孤兒藥資格認定(ODD),用於治療IIB-IV期黑色素瘤。這是APG115繼胃癌、急性髓系白血病、軟組織肉瘤、視網膜母細胞瘤後,獲得的第五項FDA授予的孤兒藥資格認定。截至本公告日期,亞盛醫藥共有4個在研新藥獲得12項FDA孤兒藥認定。

自2011年以來,在轉移性或不可切除性黑色素瘤的臨牀治療取得了前所未有的進展。靶向療法和免疫療法等新治療方式的出現,極大的延長了患者生存週期並改善了患者生存質量4-6。免疫療法中,以抗CTLA-4單抗、抗PD-1單抗和抗 PD-L1單抗爲代表的免疫檢查點抑制劑(ICI, immune checkpoint inhibitor)的臨牀研究最成熟、應用最廣泛。儘管如此,相當數量的患者最終會出現ICI耐藥,而迄今仍沒有任何治療方式獲批用於治療ICI耐藥的黑色素瘤患者。

APG-115是亞盛醫藥在研的一種口服、高選擇性的MDM2-p53抑制劑。臨牀前研究發現,其與PD-1抑制劑聯合使用時,可以觸發適應性抗腫瘤免疫以增強抗腫瘤活性。在今年的美國臨牀腫瘤學會(ASCO)年會上,亞盛醫藥口頭報告了 APG-115聯合帕博利珠單抗的II期臨牀研究最新進展。數據顯示了良好的抗腫瘤活性和安全性,在APG-115聯合帕博利珠單抗治療PD-1 ╱ PD-L1抑制劑耐藥的黑色素瘤隊列中,有一例患者獲得完全緩解(CR),該隊列的客觀緩解率(ORR) 達24.1%,疾病控制率(DCR)達55.2%。這一數據爲APG-115和免疫腫瘤藥物的協同作用提供了臨牀驗證,也爲ICI耐藥的黑色素瘤患者帶來了新的治療希望。

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