亚盛医药(06855.HK)与阿斯利康血液研发卓越中心Acerta制药达成临床合作
格隆汇6月22日丨亚盛医药-B(06855.HK)发布公告,公司与阿斯利康(LSE/STO/NYSE:AZN)血液研发卓越中心Acerta制药已达成一项临床研究合作。基于合作的条款,亚盛医药将支持其BCL-2选择性抑制剂APG-2575与Acerta制药的布鲁顿酪氨酸蛋白激酶(BTK)抑制剂CALQUENCE®(acalabrutinib)的联合治疗展开临床研究,以评估该联合用药在复发难治慢性淋巴细胞白血病(CLL)╱小淋巴细胞淋巴瘤(SLL)患者中的临床效果及安全性。
该项研究为全球多中心、开放性Ib/II期剂量递增及剂量扩展探索研究,旨在评估APG-2575单药或联合CALQUENCE®治疗复发难治CLL/SLL患者的安全性、耐受性及抗癌活性。该试验目前已经在美国开展并完成首例患者给药,并拟扩展至欧洲及澳大利亚。
CLL/SLL是一种成熟B淋巴细胞克隆增殖性肿瘤,是欧美最常见的成人白血病,约占所有白血病新发病例的30%。尽管一线方案明显提高初治反应率,很多CLL患者需长期治疗以维持该反应率,一旦复发往往预后极差。而近期有关CLL的研究发现,BTK抑制剂联合另一个BCL-2抑制剂能加深反应率,甚至缩短治疗周期,令患者达致临床治愈并因此停止治疗。
APG-2575是亚盛医药在研的新型口服BCL-2选择性抑制剂,通过选择性抑制BCL-2来恢复肿瘤细胞的程序性死亡机制,拟用于治疗多种血液恶性肿瘤。自2020年3月以来,公司就APG-2575获得中国、美国多项Ib/II期临床试验许可。
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