康方生物(09926.HK):合作伙伴SUMMIT THERAPEUTICS宣佈完成依沃西(PD-1/VEGF雙特異性抗體)III期臨牀HARMONI試驗的首例患者給藥
格隆匯5月10日丨康方生物(09926.HK)發佈公吿,集團的合作伙伴Summit Therapeutics Inc.(納斯達克股票代碼:SMMT)(“Summit”)已確定依沃西(PD-1/VEGF)即將啟動在非小細胞肺癌(NSCLC)領域臨牀III期試驗的首兩個適應症。
根據披露,依沃西聯合化療治療表皮生長因子受體(EGFR)突變的、接受過第三代EGFR酪氨酸激酶抑制劑(TKI)治療後進展的局部晚期或轉移性非鱗狀非小細胞肺癌(“HARMONi”,NCT05184712)。HARMONi是一項全球多中心、隨機、雙盲III期臨牀試驗。HARMONi臨牀試驗已在美國首例患者給藥。HARMONi將在美國、加拿大、歐洲和中國總計入組超400位受試者,在中國的部分稱為AK112-301。公司負責在中國的受試者入組,此部分已於前期完成;Summit將會負責在美國、加拿大和歐洲的受試者入組。
依沃西聯合化療一線治療轉移性鱗狀非小細胞肺癌(“HARMONi-3”):Summit計劃將在2023年下半年完成HARMONi-3試驗的首例病人給藥。
2022年12月6日,康方生物與Summit訂立合作及許可協議,並授予Summit於美國、加拿大、歐洲及日本開發及商業化其突破性雙特異性抗體依沃西(PD-1/VEGF,AK112)的獨家許可權。
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