亞盛醫藥(06855.HK)與默沙東達成一項臨牀合作
格隆匯7月6日丨亞盛醫藥(06855.HK)宣佈，公司與默沙東(MSD)已達成一項臨牀研究合作。雙方將就公司在研原創MDM2-p53抑制劑APG-115與默沙東的PD-1單抗KEYTRUDA®(pembrolizumab)的聯合治療展開臨牀研究，以評估該聯合用藥在晚期實體瘤患者中的臨牀效果。
基於合作協議，公將支持該項開放性Ib/II期臨牀研究(NCT03611868)，以評估APG-115聯合KEYTRUDA®治療多種實體瘤(如非小細胞肺癌、黑色素瘤、尿路上皮癌、脂肪瘤、惡性周圍神經鞘瘤和經PD-1/PD-L1治療產生耐藥或復發、以及未經過PD-1/PD-L1治療的ATM突變╱Tp53野生型腫瘤)患者的安全性和有效性。該研究的II期階段已開始，並計劃在美國各地共招募80名患者。公與默沙東將採用聯合開發委員會交換研究信息。
臨牀前研究表明，APG-115可促進T細胞產生促炎細胞因子，增強CD4+T細胞的活化，提高PD-L1在多種腫瘤細胞中的表達。APG-115聯合PD-1抑制劑使用後的抗腫瘤活性在多項腫瘤模型中明顯增強。Ib期試驗結果已在2020年美國臨牀腫瘤學會(ASCO)年會上發表，結果證明APG-115與帕博利珠單抗的聯合使用具有良好的耐受性，在多種腫瘤類型中的抗腫瘤活性顯著。
APG-115是一款口服生物可利用的、高選擇性的小分子MDM2-p53抑制劑。APG-115對MDM2具有高度結合親和力，通過阻斷MDM2-p53相互作用從而恢復p53腫瘤抑制活性。APG-115已在美國啟動單藥臨牀I期、聯合帕博利珠單抗治療晚期實體瘤╱轉移性黑色素瘤的臨牀Ib/II試驗、單藥或聯合化療治療唾液腺癌的I/II期等三項臨牀研究；APG-115是首個在中國進入臨牀階段的MDM2-p53抑制劑，已獲批開展包括單藥I期研究、單藥或聯合化療治療AML╱骨髓增生異常綜合徵(MDS)的Ib期研究等臨牀試驗。
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