亞盛醫藥(06855.HK)與阿斯利康血液研發卓越中心Acerta製藥達成臨牀合作
格隆匯6月22日丨亞盛醫藥-B(06855.HK)發佈公告,公司與阿斯利康(LSE/STO/NYSE:AZN)血液研發卓越中心Acerta製藥已達成一項臨牀研究合作。基於合作的條款,亞盛醫藥將支持其BCL-2選擇性抑制劑APG-2575與Acerta製藥的布魯頓酪氨酸蛋白激酶(BTK)抑制劑CALQUENCE®(acalabrutinib)的聯合治療展開臨牀研究,以評估該聯合用藥在復發難治慢性淋巴細胞白血病(CLL)╱小淋巴細胞淋巴瘤(SLL)患者中的臨牀效果及安全性。
該項研究為全球多中心、開放性Ib/II期劑量遞增及劑量擴展探索研究,旨在評估APG-2575單藥或聯合CALQUENCE®治療復發難治CLL/SLL患者的安全性、耐受性及抗癌活性。該試驗目前已經在美國開展並完成首例患者給藥,並擬擴展至歐洲及澳大利亞。
CLL/SLL是一種成熟B淋巴細胞克隆增殖性腫瘤,是歐美最常見的成人白血病,約佔所有白血病新發病例的30%。儘管一線方案明顯提高初治反應率,很多CLL患者需長期治療以維持該反應率,一旦復發往往預後極差。而近期有關CLL的研究發現,BTK抑制劑聯合另一個BCL-2抑制劑能加深反應率,甚至縮短治療週期,令患者達致臨牀治癒並因此停止治療。
APG-2575是亞盛醫藥在研的新型口服BCL-2選擇性抑制劑,通過選擇性抑制BCL-2來恢復腫瘤細胞的程序性死亡機制,擬用於治療多種血液惡性腫瘤。自2020年3月以來,公司就APG-2575獲得中國、美國多項Ib/II期臨牀試驗許可。
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