創勝集團-B(06628.HK):ASCO 2024首次公佈Osemitamab (TST001)三聯療法一線治療胃或胃食管結合部腺癌令人鼓舞的II期臨牀數據的最新業務進展
格隆匯5月24日丨創勝集團-B(06628.HK)公佈Osemitamab (TST001)聯合納武利尤單抗和CAPOX作為晚期胃或胃食管結合部腺癌一線治療的I/IIa期G隊列研究數據。該項研究的患者未經過CLDN18.2和PD-L1 CPS表達篩選入組,研究結果顯示三聯療法取得令人鼓舞的療效,特別在CLDN18.2高╱中表達的患者羣體中(無論PD-L1 CPS表達水平如何)尤為顯著。
Osemitamab (TST001)聯合納武利尤單抗和CAPOX作為晚期胃或胃食管結合部腺癌一線治療的I/IIa期G隊列研究數據將以壁報形式(摘要#4048)於2024年6月1日在美國芝加哥舉辦的ASCO 2024年會公佈。
“該II期臨牀結果標誌着Osemitamab (TST001)在研發進程中取得重要里程碑,數據顯示Osemitamab (TST001)具有顯著的抗腫瘤效果,特別在CLDN18.2高╱中表達(包括PD-L1 CPS<5)的患者羣體中療效尤為明顯,這與臨牀前數據和假設的作用機制相吻合。”公司全球藥物開發執行副總裁,首席醫學官Caroline Germa博士表示,“在上述患者羣體中,三聯療法相較於免疫檢查點抑制劑或CLDN18.2抗體與化療聯用,取得了更為優異的無進展生存期獲益。該結果進一步驗證了已獲得FDA和CDE批准的Osemitamab (TST001)全球III期試驗策略的可行性,我們將加速推動Osemitamab (TST001)的臨牀進程,使其成為全球性療法,提升HER2陰性轉移性胃或胃食管結合部腺癌的現行標準治療。”
“這項研究的臨牀結果令人振奮,該療法有望改善HER2陰性轉移性胃或胃食管結合部腺癌患者的一線治療效果並延長無進展生存期和總生存期,”北京大學腫瘤醫院消化腫瘤內科及I期臨牀試驗病區主任,以及本次研究的主要研究者沈琳教授表示,“我們期待在即將到來的ASCO 2024年會上與大家分享詳細數據。”
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