貝達藥業(300558.SZ)：BPI-D0316膠囊完成II期臨牀試驗並取得臨牀試驗總結報吿
格隆匯2月8日丨貝達藥業(300558.SZ)宣佈，近日，公司在研產品BPI-D0316膠囊在完成II期臨牀試驗後，經過一系列數據管理和統計分析工作已取得臨牀試驗總結報吿。
BPI-D0316膠囊是第三代表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI)，註冊分類為化學藥品1類，此次申報藥品註冊依據的是“BPI-D0316膠囊在EGFR突變局部晚期或轉移性非小細胞肺癌患者中的II期臨牀試驗”，評估研究藥物在既往接受一代或二代EGFR-TKI治療後產生耐藥且EGFR-T790M突變陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)患者中的療效和安全性。
該研究為多中心、開放、單臂II期臨牀研究，290例受試者納入研究，數據截止日期為2020年10月18日。研究結果顯示BPI-D0316膠囊75-100mg治療既往使用EGFR-TKI耐藥後產生T790M突變的局部晚期或轉移性NSCLC患者，經獨立評審委員會(IRC)評估的客觀緩解率(ORR)為64.8%，疾病控制率(DCR)為95.2%。顱內客觀緩解率(iORR)為52.9%，顱內疾病控制率(iDCR)為97.1%，提示BPI-D0316膠囊對顱內病灶同樣具有較好的療效。從數值上看，BPI-D0316膠囊的整體療效和顱內療效均與其他三代EGFR-TKI基本一致。無進展生存期(PFS)數據尚未成熟。
安全性方面，BPI-D0316膠囊用於EGFR-TKI耐藥後產生T790M突變的局部晚期或轉移性NSCLC患者安全耐受性良好，儘管大部分患者均會發生不良反應，但大多為1級或2級，最常見的不良反應為血小板減少症、頭痛、白細胞計數降低等。最常見的3級及以上不良反應為血小板減少症，不良反應經暫停用藥和/或對症治療等可恢復或緩解，提示BPI-D0316膠囊的不良反應可耐受可控、轉歸良好。
綜上所述，BPI-D0316膠囊75-100mg治療既往使用EGFR-TKI耐藥後產生T790M突變的局部晚期或轉移性NSCLC患者具有較好的療效和安全性，可為EGFR-TKI耐藥後產生T790M突變的NSCLC患者提供新的有效的治療選擇。截至目前，國內已有奧希替尼和阿美替尼兩款第三代EGFR-TKI獲得批准及上市。
根據國家藥品註冊相關法規規定，BPI-D0316膠囊經NMPA藥品審評中心審評審批通過並頒發新藥證書、生產批件後方可投入生產、銷售，公司將繼續做好相關上市準備工作，爭取儘早讓新藥造福患者。同時BPI-D0316膠囊的一線臨牀研究也在全力推進中。
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