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AFFIRM-205患者入組順利推進 來凱醫藥(2105.HK)乳腺癌III期臨牀研究令人期待
格隆匯 07-02 12:55

2024年7月2日——由中國醫學科學院腫瘤醫院徐兵河院士牽頭的"評價Afuresertib+氟維司羣在標準治療失敗的局部晚期或轉移性HR+/HER2-乳腺癌患者中的有效性和安全性的III期研究" (AFFIRM-205)研究者會6月23日在北京舉行。

來自全國47家腫瘤研究中心的50多位乳腺癌領域專家,共同回顧了前期研究的安全性和有效性數據,同時圍繞Ⅲ期臨牀試驗的研究方案和實施策略進行了深入討論。

據世界衞生組織國際癌症研究機構(IARC),乳腺癌位居中國女性癌症發病第二位,2022年新發病例預估35.7萬[,其中約62%中國患者屬於HR+/HER2-(激素受體陽性、人表皮生長因子受體2陰性)這一類分子亞型。儘管大多數此類乳腺癌患者初始可從一/二線內分泌+CDK4/6抑制劑和/或者化療中獲益,但一段時間後,大部分可能會產生耐藥,導致治療失敗,患者亟需耐藥後的新型治療選擇。

來凱醫藥(2105.HK)的afuresertib(LAE002) 是全球僅有的兩種處於或完成關鍵臨牀開發階段的抗癌AKT抑制劑之一。在此前進行的Ib期研究結果顯示,相比氟維司羣單藥治療PFS3-4個月,afuresertib聯合氟維司羣的中位PFS大幅增加到了7.3個月,同時表現出良好的安全性。

徐兵河院士表示,Ib研究初步顯示出AKT抑制劑對乳腺癌,特別是對PIK3CA/AKT1/PTEN改變的HR+/HER2-局部晚期或轉移性乳腺癌治療的潛力。5月底,AFFIRM-205已在中國醫學科學院腫瘤醫院完成了首例患者給藥,全體與會專家對下一步III期臨牀研究充滿期待。

目前AFFIRM-205全國47家中心的患者入組工作正順利推進。截止6月30日,研究已經篩選10例乳腺癌患者。

Afuresertib(LAE002) 是全球僅有的兩種處於或完成關鍵臨牀開發階段的抗癌AKT抑制劑之一。

Afuresertib是一種AKT強效抑制劑,抑制所有三種AKT亞型(AKT1、AKT2及AKT3),根據公開數據,與其他AKT抑制劑相比,Afuresertib具有療效更高、藥效更好、腫瘤抑制暴露更顯著、安全性更佳等多項優勢。Capivasertib是阿斯利康首個獲批的AKT抑制劑,於2023年11月經FDA批准用於HR+/HER2-乳腺癌。

來凱醫藥在2023年美國聖安東尼奧乳腺癌研討會(SABCS)上展示了針對HR+/HER2-乳腺癌的afuresertib Ib期研究療效,數據良好,因此已啟動 III期關鍵研究AFFIRM-205。來凱醫藥將繼續開展治療乳腺癌、前列腺癌、卵巢癌及PD–1/PD-L1耐藥實體瘤的臨牀試驗,以解決未被滿足的醫療需求。在多項臨牀試驗中,afuresertib與其他療法的組合展示良好的療效結果。

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