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來凱醫藥-B(02105.HK):美國FDA批准LAE 002(AFURESERTIB)加LAE 001聯合療法治療前列腺癌III期臨牀試驗方案
格隆匯 05-23 08:20

格隆匯5月23日丨來凱醫藥-B(02105.HK)發佈公吿,集團已獲得美國食品和藥品管理局(“美國FDA”)就 LAE 002(afuresertib,一種AKT抑制劑)聯合LAE 001(CYP17A1/CYP11B2雙重抑制劑)(“LAE201”)針對經過標準治療後的轉移性去勢抵抗性前列腺癌(mCRPC)患者進行III期臨牀試驗方案的批准。

集團於2021年6月在美國和2022年9月在韓國啟動了LAE201針對經過標準治療後的m CRPC患者的國際多中心II期臨牀試驗。該試驗是一項開放標籤、劑量遞增和劑量擴展研究,旨在評估該組合候選藥物的療效和安全性。該研究對m CRPC患者顯示出積極的治療效果。截至2023年11月21日,在II期推薦劑量下,入組了40名在1–3線標準治療中出現進展的患者,其中包括至少接受過1線阿比特龍或第二代AR拮抗劑治療的患者,中位r PFS為8.1個月。這與過去標準治療下m CRPC患者的中位r PFS為2至4個月相比,是一個顯著的改善。該聯合療法普遍耐受性良好,治療期間出現的不良事件可控,且可在常規治療後恢復。集團已與美國FDA討論了隨後的III期關鍵試驗設計,並於2024年5月獲得了試驗方案的批准。集團計劃將這種精準療法帶給需要新型治療選擇的m CRPC患者。

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