歌禮制藥-B(01672.HK)：國家藥監局批准開展ASC40聯合貝伐珠單抗治療複發性膠質母細胞瘤患者III期臨試
格隆匯7月22日丨歌禮制藥-B(01672.HK)發佈公吿，中國國家藥品監督管理局已批准開展ASC40聯合貝伐珠單抗治療複發性膠質母細胞瘤(rGBM)患者的III期臨牀試驗。
該III期註冊研究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(PFS)、總生存期(OS)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)。
貝伐珠單抗是中國目前唯一用於治療複發性膠質母細胞瘤的藥物，該適應症於 2020年9月獲批。BELOB試驗的數據表明，使用貝伐珠單抗治療的複發性膠質母細胞瘤患者，中位無進展生存期為3個月。研究數據顯示脂質代謝在多種腫瘤中起着關鍵調控作用。脂肪酸合成酶(FASN)是調節脂質代謝的最重要的蛋白質之一。許多實體瘤和血液腫瘤中均發現脂肪酸合成酶的過度表達，包括複發性膠質母細胞瘤、非小細胞肺癌、乳腺癌、卵巢癌、前列腺癌、結腸癌、胰腺癌和非霍奇金淋巴瘤。
ASC40(國外代號為TVB-2640)是一種強效安全的選擇性脂肪酸合成酶口服小分子抑制劑。II期臨牀試驗數據顯示，ASC40 (TVB-2640)聯合貝伐珠單抗的總緩解率(ORR)為65%，包括20%的完全緩解率(CR)和45%的部分緩解率(PR)。此外， II期數據顯示，ASC40 (TVB-2640)聯合貝伐珠單抗觀察到的6個月無進展生存期 (PFS6)為47%，相比較過往貝伐珠單抗單藥治療的6個月無進展生存期歷史數據 16%(BELOB試驗，P =0.01)，在統計學上有顯著意義。ASC40 (TVB-2640)聯合貝伐珠單抗治療複發性膠質母細胞瘤患者安全性和耐受性良好(臨牀試驗註冊編號：NCT03032484)。
在美國和英國完成的分別接受ASC40 (TVB-2640)單藥或聯合紫杉烷治療的136名晚期腫瘤患者I期臨牀試驗數據表明：ASC40 (TVB-2640)在晚期實體瘤尤其是在有KRAS突變的肺癌、卵巢癌和乳腺癌患者中，顯示出脂肪酸合成酶靶向激活、良好的安全性、藥代動力學以及良好應答(臨牀試驗註冊編號：NCT02223247)。ASC40 (TVB-2640)在美國還有多項臨牀試驗正在開展，包括針對KRAS突變的非小細胞肺癌(臨牀試驗註冊編號：NCT03808558)和乳腺癌(臨牀試驗註冊編號： NCT03179904)的臨牀試驗。
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