亞盛醫藥-B(06855.HK)：Bcl-2抑制劑APG-2575獲美國FDA臨牀試驗許可
格隆匯6月15日丨亞盛醫藥-B(06855.HK)公佈，公司在研原創新藥Bcl-2抑制劑APG-2575的臨牀試驗申請獲美國食品藥品管理局（美國FDA）許可，將展開單藥或與抗癌藥物聯合治療晚期ER+乳腺癌或實體瘤的研究。
該研究是一項全球多中心、開放性、Ib/II期臨牀研究，旨在評估APG-2575單藥治療晚期實體瘤患者，或聯合CDK4/6抑制劑palbociclib治療CDK4/6抑制劑治療後進展或復發的ER+/HER2-轉移性乳腺癌患者的安全性、耐受性、藥代動力學特徵及初步療效。
乳腺癌是女性最常見的惡性腫瘤之一，大約75%的乳腺癌患者為激素受體陽性(HR+)乳腺癌，主要為雌激素受體陽性(ER+)，該亞型中約85%為Bcl-2過表達。內分泌治療是早期和轉移階段HR+/HER2-乳腺癌治療的基石。在轉移性ER+乳腺癌的一綫治療中，CDK4/6抑制劑（包括palbociclib、ribociclib和abemaciclib）聯合激素療法通過靶向CCND1-CDK4/6-RB通路與單用激素療法相比，可延長無進展生存期(PFS)和最終總生存(OS)3,4；而在二線治療中，PI3K抑制劑聯合氟維司羣與依維莫司聯合內分泌治療可以通過靶向PI3K-AKT-mTOR通路克服既往治療的選擇壓力。然而，內分泌治療和靶向治療的耐藥性較難避免，並最終需要化療，因此探索其他新的靶向治療阻斷現有的突變途徑和推遲化療是亟待解決的臨牀問題。
據悉，APG-2575是亞盛醫藥在研的新型口服Bcl-2選擇性小分子抑制劑，通過選擇性抑制Bcl-2蛋白來恢復腫瘤細胞程序性死亡機制（細胞凋亡），從而誘導腫瘤細胞凋亡，達到治療腫瘤的目的。APG-2575是首個在中國進入臨牀階段的、本土研發的Bcl-2選擇性抑制劑，目前已獲得中國、美國、澳大利亞及歐洲的多項Ib/II期臨牀試驗許可，正在全球同步推進多個血液腫瘤適應症的臨牀開發。作為單藥，APG-2575對於Bcl-2依賴的腫瘤細胞具有強的抗腫瘤活性，並且與其他抗癌藥物組合表現出更廣泛的抗腫瘤活性。
此前，APG-2575聯合palbociclib的臨牀前研究結果顯示，palbociclib通過誘導細胞週期阻滯而導致細胞衰老，而APG-2575增加促凋亡蛋白BIM等表達，下調ER水平，降低磷酸化的Rb蛋白、細胞週期蛋白D1和E的蛋白水平。因此，Bcl-2抑制劑和CDK4/6抑制劑聯合用藥不僅可以協同增強誘導細胞週期停滯，還可以促進ER+乳腺癌細胞凋亡。
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