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微芯生物(688321.SH):西達本胺胺聯合恩沃利單抗治療經PD-1抑制劑治療耐藥獲批臨牀試驗
格隆匯 06-17 18:38

格隆匯6月17日丨微芯生物(688321.SH)公佈,公司近日收到國家藥品監督管理局簽發的《藥物臨牀試驗批准通知書》,其同意西達本胺聯合恩沃利單抗治療經PD-1抑制劑治療耐藥的非小細胞肺癌的開放、多中心II期臨牀研究。

西達本胺(Chidamide;商品名為“愛譜沙®/Epidaza®”),國家1類原創新藥,是公司獨家發現的新分子實體藥物,機制新穎,是全球首個亞型選擇性組蛋白去乙酰化酶(HDAC)抑制劑,可單獨或聯合其他藥物解決嚴重威脅人類健康的惡性腫瘤等疾病。目前已有兩個適應症成功獲批上市,用於治療外周T細胞淋巴瘤和乳腺癌。

非小細胞肺癌是除小細胞肺癌外所有肺癌組織分型的總稱,包括鱗狀細胞癌、腺癌和大細胞癌,非小細胞肺癌約佔總體肺癌患者的85%。根據2018年在癌症免疫治療協會年會(SITC)公開披露的Ib/II期臨牀試驗結果,晚期非小細胞肺癌患者入組13例,其中完成評價8例,客觀緩解率為38%,疾病控制率75%。西達本胺聯合免疫治療在此類患者中顯示出初步但比較明確的聯合用藥療效,進一步證實了西達本胺的獨特作用機制對非小細胞肺癌有效。

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