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科倫藥業(002422.SZ):子公司創新藥物SKB264(MK-2870)於2023年歐洲腫瘤內科學會大會網站刊發研究結果的口頭報吿摘要
格隆匯 10-16 09:05

格隆匯10月16日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司(以下簡稱"科倫博泰")將在於2023年10月20日至24日在西班牙馬德里舉行的2023年歐洲腫瘤內科學會(ESMO)大會上,以口頭報吿的形式公佈創新TROP2-ADC(SKB264,亦稱為MK-2870)用於治療激素受體陽性(HR+)和人表皮生長因子受體2陰性(HER2-)轉移性乳腺癌(mBC)患者的1/2期籃子研究的研究結果。口頭報吿定於當地時間2023年10月22日上午八時三十五分至八時四十分進行。

這是一項1/2期、單臂、籃子研究,用於治療HR+/HER2-(包括HER2低表達及HER2零表達)mBC患者,該等患者每兩週接受一次5mg/kg劑量的SKB264(MK2870)治療,直至患者出現疾病進展或產生不可耐受毒性。合格受試者包括經內分泌治療以及既往接受過至少一次化療後出現疾病進展的mBC患者。數據截止日期為2023年4月12日,中位隨訪時間為8.2個月。

在38名可評估療效的患者中,47%的患者出現原發內分泌耐藥性;79%的患者既往接受≥2次轉移性疾病化療,且既往治療包括紫杉醇類藥物及CDK4/6抑制劑。客觀緩解率(ORR)為36.8%,疾病控制率(DCR)為89.5%。中位持續緩解時間(DoR)為7.4個月,6個月DoR率為80%。中位無進展生存期(PFS)為11.1個月,6個月PFS率為61.2%。

最常見的≥3級治療相關不良事件(TRAE)(≥5%)為中性粒細胞計數減少、白細胞計數減少、貧血、血小板計數減少及y-谷氨酰轉肽酶(GGT)增加。沒有觀察到神經毒性、藥物相關的間質性肺病或非感染性肺炎的發生。沒有因TRAE導致的停藥或死亡。

科倫博泰已獲中國國家藥品監督管理局藥品審評中心(以下簡稱"國家藥監局藥審中心")同意在中國開展一項針對HR+/HER2-mBC患者的SKB264(MK-2870)註冊性3期試驗,受試者為至少一線化療失敗的mBC患者。科倫博泰亦於2023年9月26日取得國家藥監局藥審中心的研究用新藥(IND)申請批准,同意開展SKB264(MK-2870)聯合或不聯合KL-A167(抗PD-L1抑制劑)用於在轉移情況下經內分泌治療後疾病進展的HR+/HER2-mBC患者的研究。

HR+/HER2-乳腺癌是最常見的乳腺癌亞型。根據弗若斯特沙利文資料以及科倫博泰2023年6月29日的招股章程所披露的數據,2022年全球和中國分別新增130萬和18.76萬HR+/HER2-乳腺癌病例。

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