基石药业-B(02616.HK)：PD-L1抗体舒格利单抗治疗成人R/R ENKTL获美国FDA突破性疗法认定
格隆汇 10 月 23日丨基石药业-B(02616.HK)发布公告，美国食品药品监督管理局(“FDA”)授予其PD-L1抗体舒格利单抗(CS1001)治疗成人复发或难治性结外自然杀伤细胞/T细胞淋巴瘤(“R/R ENKTL”)的突破性疗法认定，这是继10月份美国FDA授予PD-L1抗体舒格利单抗孤儿药资格用于治疗T细胞淋巴瘤之后，舒格利单抗取得的又一个重要进展。
突破性疗法认定是一个新药加快开发及审批的途径，适用于治疗严重或危及生命的疾病且初步临床证据显示出显着优于现有疗法的药品。舒格利单抗获得突破性疗法后将极大加快舒格利单抗在美国的开发及商业化速度。
结外自然杀伤细胞/T细胞淋巴瘤(“ENKTL”)属于成熟T和NK细胞淋巴瘤的一个亚型。R/R ENKTL恶性程度高且侵袭性强，预后较差。R/R ENKTL患者在含门冬醯胺酶为基础的标准方案失败后，缺乏有效的挽救治疗手段,对传统治疗反应不佳。临床医生对于这类患者常常束手无策，因为疾病凶险，进展迅速，生存期极短，一年生存率不足20%。目前在中国获批的靶向单药治疗完全缓解(“CR”)率约为6%。一线治疗方案失败后的患者正面临着显着的未被满足的治疗需求。在2020年中国临床肿瘤协会年会上，舒格利单抗单药治疗R/R ENKTL患者的CS1001-201研究牵头研究者中山大学附属肿瘤医院黄慧强教授进行了口头汇报。资料显示，在38例疗效可评估患者中，客观缓解率(“ORR”)为44.7%，CR率为31.6%，中位缓解持续时间为16.8个月。接受给药的43例患者，中位总生存期19.7个月，一年总生存率为55.5%。舒格利单抗有望为这些患者提供新的治疗选择。
基石药业首席医学官杨建新博士表示：“R/R ENKTL患者正面临着显着的未被满足的治疗需求，舒格利单抗相比现有药物的疗效资料是一个巨大的突破。此次舒格利单抗能够获得美国FDA突破性疗法认定，充分证明了这款药物的巨大临床价值。我们将继续全力推进该研究，并与美国FDA和中国国家药品监督管理局密切协作，力争早日把舒格利单抗带给全球R/R ENKTL患者。”
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