科倫藥業(002422.SZ)：將在ESMO年會上口頭報吿自主創新藥物TROP2-ADC SKB264中美I期臨牀研究結果
格隆匯9月17日丨科倫藥業(002422.SZ)公佈，公司董事會獲悉，公司控股子公司四川科倫博泰生物醫藥股份有限公司(簡稱“科倫博泰”)開發的TROP2抗體-藥物偶聯物SKB264將於2021年歐洲腫瘤內科學會([2021年ESMO年會])公佈中美I期臨牀研究結果。
MD Anderson的Jordi Rodon Ahnert教授和同濟大學附屬東方醫院李進教授，是SKB264全球多中心臨牀研究的共同主要研究者，本次ESMO年會將由Jordi Rodon Ahnert教授代表整個研究團隊做大會口頭報吿(摘要號：514O)。
SKB264項目I期的中期臨牀研究結果已於歐洲中部夏令時間9月17日14:20-14:30(北京時間9月17日20:20-20:30)，在Developmental therapeutics專場以口頭報吿(Proffered Paper)形式公佈，這是SKB264首次展示研究數據，內容概要如下：
一項SKB264在局部晚期或轉移性實體瘤患者中的開放、國際多中心首次人體研究 (An open-label, global, first-in-human study of SKB264 in patients withlocally advanced or metastatic solid tumors)
SKB264是科倫博泰自主研發的創新TROP2-ADC藥物，採用獨立自主知識產權的連接子和毒素分子。在肺癌和乳腺癌動物模型中，SKB264均顯示出良好的抗腫瘤活性，同時抗腫瘤活性也呈現顯著的劑量相關性。
I期研究入組人羣為晚期/轉移性實體瘤患者，主要目的為確定最大耐受劑量(MTD)和/或推薦拓展劑量(RDEs)。
截至2021年3月15日，中美共有18例患者(中位年齡為57歲)，包括2mg/kg劑量組4例，4mg/kg劑量組7例，6mg/kg劑量組7例，55.6%的患者既往接受過≥4個治療方案。其中，TNBC患者6例(33.3%)，卵巢癌患者5例(27.8%)，胰腺癌患者3例(16.7%)，尿路上皮癌患者2例(11.1%)，胃腺癌和HER2陽性乳腺癌各1例(分別為5.6%)。患者接受每2周1次的SKB264治療，每4周為一個治療週期，每8周進行療效評估。
臨牀安全性方面，18例患者均報吿了不良事件(AEs)，其中8例患者報吿了≥3級AE，＞2例的3級AE有中性粒細胞計數降低(5/18)、白細胞計數降低(4/18)和貧血(3/18)。研究未發生導致永久停藥的AE，未發生導致死亡的AE。
臨牀有效性方面，共有17例患者接受了至少一次療效評估，入組人羣均為經多線治療失敗的、晚期或轉移性實體瘤患者。總緩解率(ORR)為35.3%(6/17)，疾病控制率(DCR)為70.6%(12/17)。在TNBC和卵巢癌中初步觀察到的ORR均為40%。
SKB264的初步臨牀研究結果顯示了在轉移性實體瘤患者(TNBC、卵巢癌、胃腺癌等)中可控的安全性和令人鼓舞的抗腫瘤活性，II期拓展研究正在繼續探索一系列適應症。
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