智通财经APP获悉,阿斯利康公司(AZN.US)今日宣布,其重磅免疫疗法Imfinzi(durvalumab)已获得欧洲药品管理局(EMA)人用药品委员会(CHMP)积极意见,推荐在欧盟(EU)获批作为单药,用于治疗接受铂类放化疗(CRT)后病情未进展的成人局限期小细胞肺癌(LS-SCLC)。
这一推荐是基于发表在《新英格兰医学杂志》上的3期临床试验ADRIATIC的结果。
小细胞肺癌(SCLC)是一种高度侵袭性的肺癌。局限期小细胞肺癌即使在标准化疗和放疗初步应答良好后,通常也会迅速复发和进展。LS-SCLC的预后尤为不良,仅有15%–30%的患者在确诊五年后仍存活。
荷兰阿姆斯特丹大学医学中心临床试验放疗教授,ADRIATIC试验主要研究员Suresh Senan博士表示:“ADRIATIC是几十年来首个在局限期小细胞肺癌中显示出生存获益的3期试验,接受Imfinzi治疗的患者死亡风险降低了27%。”
Imfinzi是一种人源化的单克隆抗体。通过与PD-L1的结合,阻断PD-L1与PD-1和CD80蛋白的结合,进而抑制肿瘤的免疫逃逸机制。
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