歌禮制藥-B(01672.HK):FASN抑制劑ASC40聯合貝伐珠單抗治療複發性膠質母細胞瘤的III期臨牀試驗完成首例患者給藥
格隆匯1月23日丨歌禮制藥-B(01672.HK)宣佈,公司的ASC40聯合貝伐珠單抗治療複發性膠質母細胞瘤患者的III期註冊臨牀試驗完成首例患者給藥。ASC40是一款選擇性的脂肪酸合成酶(FASN)口服小分子抑制劑,脂肪酸合成酶是調節脂肪酸從頭合成(DNL)途徑中的關鍵酶。ASC40通過阻斷脂肪酸從頭合成,抑制腫瘤細胞能量供應和擾亂腫瘤細胞膜磷脂組成。
該III期註冊臨牀試驗(臨牀試驗註冊編號:NCT05118776)是一項在中國開展的隨機、雙盲、安慰劑對照、多中心臨牀試驗,旨在評估複發性膠質母細胞瘤患者的無進展生存期、總生存期和安全性。計劃入組約180名患者,以1:1的比例隨機分配進入隊列1(每日口服一次ASC40片劑+貝伐珠單抗)和隊列2(每日一次安慰劑片劑+貝伐珠單抗)。該III期臨牀試驗180名複發性膠質母細胞瘤患者中約80%患者預計在2022年12月底前完成隨機入組。
在美國完成的複發性膠質母細胞瘤II期臨牀試驗顯示,ASC40聯合貝伐珠單抗的客觀緩解率為65%,包括20%的完全緩解和45%的部份緩解。
根據發表數據,在中國,膠質母細胞瘤佔膠質瘤的57%,年發病率約為2.85~4.56例 ╱10萬人,據此估算,每年約有4萬~6.4萬新發膠質母細胞瘤病例。在手術、放療、化療後超過90%的膠質母細胞瘤患者會出現復發。在美國,膠質母細胞瘤佔膠質瘤的56.6%,年發病率約為3.21例╱10萬人。
歌禮腫瘤管線除了脂肪酸合成酶抑制劑外,還有兩款完全自主研發的口服PD-L1小分子抑制劑,即ASC61和ASC63。歌禮已遞交ASC61用於治療晚期實體瘤的美國臨牀試驗申請。
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