基石藥業-Ｂ(02616.HK)宣佈PD-L1抗體CS1001在MSI-H/dMMR實體瘤患者中顯示出良好的相關數據
格隆匯9月22日丨基石藥業-Ｂ(02616.HK)發佈公告，公司在第二十二屆中國臨牀腫瘤學會(“CSCO”)年會上，以口頭報告形式首次發表了公司的在研抗PD-L1抗體CS1001在一項名為GEMSTONE-101的Ib期高度微衞星不穩定/細胞錯配修復機制缺失(“MSI‐H/dMMR”)隊列的研究數據。
本次公佈的MSI-H/dMMR隊列研究，主要目的為評價CS1001作為二線及以上治療的初步抗腫瘤療效，以及進一步評估CS1001的安全性和耐受性。
微衞星(MS)是DNA上由簡單串聯重複片段組成的特徵序列，若細胞錯配修復機制缺失，微衞星序列可能增長或截短，這種現象稱為微衞星不穩定(“MSI”)。MSI‐H即表示微衞星不穩定性強，提示腫瘤細胞錯配修復缺失，可能存在大量突變相關腫瘤抗原，從而對免疫療法產生良好應答。目前已發表的數據顯示，MSI-H/dMMR最常見於子宮內膜癌、胃腺癌、小腸惡性腫瘤及結直腸腺癌患者中。
北京大學腫瘤醫院副院長、本次研究報告人沈琳教授表示：“該隊列研究的初步療效數據顯示，CS1001在MSI-H/dMMR實體瘤患者中已表現出良好的抗腫瘤活性，同時，CS1001也顯示出良好的安全性和耐受性。”
基石藥業董事長、執行董事兼首席執行官江寧軍博士表示：“很高興看到我們的核心PD-L1候選藥物CS1001在MSI-H/dMMR隊列研究中取得了良好的初步結果。目前，全球尚無獲批用於治療此類實體瘤的PD-L1抑制劑，我們期待CS1001在之後的研究中能在更廣泛的瘤種中顯示出治療潛力，成為在MSI-H/dMMR實體瘤治療領域進展最快的免疫治療藥物。”
基石藥業首席醫學官楊建新博士表示：“基於MSI-H/dMMR實體瘤對免疫療法具有良好應答的特性，有效的免疫治療將有望為這類患者帶來生存獲益。在此次發佈的研究結果中，CS1001已顯示出其治療潛力，客觀緩解率為38.1%，且其中28.6%已確認。相比於其他此前已獲批准的PD-1藥物，這對於經過既往多次治療的患者來説是十分出色的結果。同時，作為一種最接近人體的天然G型免疫球蛋白4(IgG4)單抗藥物，我們也期待CS1001在之後的臨牀試驗中展現它在安全性方面的獨特優勢。”
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