康寧傑瑞製藥-B(09966.HK)將於WCLC 2020展示KN046治療晚期NSCLC患者臨牀數據以及KN046治療罕見胸部腫瘤患者初步結果摘要
格隆匯 1 月 13日丨康寧傑瑞製藥-B(09966.HK)發佈公吿，有關(i)KN046(一種重組人源化PD-L1/CTLA-4雙特異性抗體)治療晚期NSCLC患者的II期臨牀研究的臨牀數據及(ii)KN046治療罕見胸部腫瘤患者的I期臨牀研究的初步安全性及療效結果的摘要已獲准於即將舉行的2020年世界肺癌大會(“WCLC 2020”)上展示。WCLC 2020為匯聚全世界肺癌及胸部腫瘤學領域臨牀醫生、研究人員及科學家的最大國際盛會。WCLC 2020將於2021年1月28日至2021年1月31日舉行。兩項研究的臨牀數據將分別以海報及口頭報吿形式發佈。
KN046-201為一項II期、開放、多中心臨牀研究，旨在評估KN046治療晚期 NSCLC受試者的療效、安全性及耐受性。共招募64例既往接受過NSCLC一線系統性治療的患者。此外，KN046-AUS-001為於澳大利亞進行的I期臨牀研究。其中入組五例罕見胸部腫瘤患者，其中包括四例胸腺上皮腫瘤患者(兩例胸腺癌患者(IV期)、兩例胸腺瘤患者(IV期))及一例胸膜間皮瘤患者(肉瘤樣變，IIIB期)。中位治療時間為22.7周(範圍：16至48周)。
公吿表示，KN046是集團自主研發的全球首創PD-L1/CTLA-4雙特異性抗體。KN046同時靶向兩個臨牀驗證的免疫檢查點，PD-L1及CTLA-4。目前，KN046在澳大利亞和中國已開展覆蓋十多種腫瘤(包括NSCLC、三陰乳腺癌、食管鱗癌、肝細胞癌及胰腺癌)的約20項不同階段臨牀試驗。該等臨牀試驗結果初步顯示出KN046具有良好的安全性和有效性。基於在中國及澳大利亞取得的臨牀試驗結果，美國食品藥品監督管理局已批准集團於美國直接進入KN046的II期臨牀試驗。目前，旨在評估KN046聯合含鉑化療對局部晚期不可切除或轉移性鱗狀NSCLC患者的療效及安全性的III期臨牀試驗已在中國啟動。 KN046的臨牀前及臨牀試驗結果表明可顯著減少對人體外周系統可能產生的毒副作用。公司認為，KN046有望成為突破性腫瘤免疫特效藥。
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