康辰藥業(603590.SH)：KC1036在既往標準治療失敗的晚期食管鱗癌受試者中療效顯著、安全性良好，臨牀數據支持進一步開展關鍵性註冊III期臨牀研究
格隆匯3月31日丨康辰藥業(603590.SH)公佈，KC1036片(簡稱“KC1036”)是公司自主研發的化學藥品1類創新藥，目前正在進行晚期實體腫瘤多適應症臨牀研究。中國醫學科學院腫瘤醫院主任醫師黃鏡教授在中國醫藥創新與投資大會上宣講了KC1036最新臨牀研究的報吿如下：
2023年3月29日，中國醫學科學院腫瘤醫院主任醫師黃鏡教授在中國醫藥創新與投資大會上宣講了《KC1036治療既往標準治療失敗的晚期食管鱗癌的有效性》的報吿，重點介紹了既往標準治療失敗的晚期食管鱗癌受試者接受KC1036單藥治療的臨牀結果。
KC1036於2020年1月獲得國家藥品監督管理局批准開展臨牀研究。迄今，KC1036已開展多項I期和II期臨牀研究，已入組超過100多例晚期實體腫瘤受試者，其中，晚期食管鱗癌受試者入組比例超過三分之一。
所有入組的晚期食管鱗癌受試者，均接受KC103660mg每日1次口服給藥，每21天作為一個週期給藥，直到出現疾病進展，死亡或無法耐受的毒性反應。療效終點是研究者根據RECIST1.1評估的客觀緩解率(ORR)和疾病控制率(DCR)。
臨牀研究結果：截至2022年12月，共入組32例既往標準治療失敗的晚期食管鱗癌受試者，受試者中位年齡62歲，81.3%受試者為男性，84.4%受試者的ECOG評分為1分，既往二線及以上治療失敗受試者佔50%。
在有效性方面，在可療效評估的27例晚期食管鱗癌受試者中，有8例最佳療效為部分緩解(PR)，有15例為疾病穩定(SD)，有4例為疾病進展(PD)，客觀緩解率(ORR)為29.6%，疾病控制率(DCR)為85.2%。其中，有74.1%受試者的靶病灶縮小，最長治療週期已超過9個月。
關於安全性，KC1036在晚期實體腫瘤受試者中均表現出良好的安全性和耐受性，且依從性高。絕大多數治療相關不良事件(TRAE)為1～2級，少見3級TRAE，發生率最高的3級TRAE為高血壓(8.5%)。KC1036在晚期食管鱗癌受試者中的安全性特徵與晚期實體腫瘤受試者基本一致。
報吿結論：KC1036是一種II型非競爭性AXL、VEGFR多靶點受體酪氨酸激酶抑制劑，在既往標準治療失敗的晚期食管鱗癌受試者中療效顯著、安全性良好，臨牀數據支持進一步開展關鍵性註冊III期臨牀研究。
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