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四環醫藥(00460.HK):軒竹生物研發的創新藥吡洛西利聯合氟維司羣治療HR+╱HER2-晚期乳腺癌臨牀III期期中分析結果在《Nature Communications》學術期刊發表
格隆匯 04-10 12:34

格隆匯4月10日丨四環醫藥(00460.HK)宣佈,集團旗下非全資附屬公司軒竹生物科技股份有限公司("軒竹生物")研發的創新藥吡洛西利(Bireociclib)取得了重大科研突破,其聯合氟維司羣治療HR+╱HER2-晚期乳腺癌臨牀III期研究(BRIGHT-2,NCT05077449)期中分析結果,已正式刊登於頂級期刊Nature子刊《Nature Communications》。

BRIGHT-2研究是由中國醫學科學院腫瘤醫院徐兵河院士牽頭開展的隨機雙盲III期試驗。該試驗聚焦中國乳腺癌患者,他們普遍診斷年齡小、分期晚,Luminal B型比例高,晚期化療應用多,復發風險大。研究從國內64箇中心招募305例經內分泌治療後進展的HR+╱HER2-晚期乳腺癌患者。這些患者中位年齡55歲,37.0%絕經前,68.2%有內臟轉移,25.6%原發耐藥,23.9%晚期接受過化療,91.5%在治療期病情進展,整體病情複雜棘手。

在此次試驗里,吡洛西利聯合氟維司羣療效顯著。中位隨訪8.7個月時,聯合組中位PFS達12.94個月,遠超氟維司羣組的7.29個月。各亞組患者均有PFS獲益,尤其是內分泌原發耐藥、單純骨轉移、肝轉移患者風險降低明顯,聯合組客觀緩解率爲39.7%,能使腫瘤縮小,緩解症狀,帶來生存獲益。

在本次研究中,吡洛西利面對人羣更復雜、疾病更難治的挑戰,依然獲得了突出生存數據。這一成果是在吡洛西利單藥後線治療數據全球領先的基礎上取得的,進一步鞏固了其在CDK4/6抑制劑中的Bestin Class地位。

此次研究數據的公佈,不僅是四環醫藥創新研發實力的有力證明,也意味着我們在爲全球乳腺癌患者提供更有效治療方案的道路上邁出了堅實一步。未來,四環醫藥將繼續秉承創新驅動的發展理念,加大研發投入,加速創新成果轉化,爲全球患者的健康福祉貢獻更多力量。

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