和黃醫藥(00013.HK)披露治療淋巴瘤藥物臨牀數據
和黃醫藥(00013.HK)公佈,於第63屆美國血液學會(ASH)年會暨博覽會上公佈HMPL-523進行中的臨牀試驗的最新分析結果。
HMPL-523治療成人原發免疫性血小板減少症的安全性、藥代動力學特徵及初步療效:一項隨機、雙盲、安慰劑對照的Ib期臨牀試驗,報告發布總共41名無論是隨機分組至接受活性治療還是在研究的開放標籤階段交叉的接受過HMPL-523所有劑量治療的患者的安全性數據。中位治療持續時間爲142天(範圍:23-170)。未出現患者因治療相關不良事件(TRAE)而停止治療,亦未出現治療相關的嚴重不良事件(SAE)報告。共有30名患者(73%)出現TRAE,其中3名(7.3%)出現 3 級或以上TRAE,其中1人是接受RP2D治療。 沒有超過一名患者以上的3級或以上的TRAE發生。
至於選擇性口服Syk抑制劑HMPL-523治療復發或難治性淋巴瘤患者的I期臨牀試驗初步結果,在所有入組的21名患者中,17名(81%)患者出現TRAE,其中7名(33.3%)出現3級或以上TRAE。對於3級或以上的TRAE,兩名患者發生中性粒細胞減少症,是唯一發生在超過一名患者中的3級或以上的TRAE。6名患者(28.6%)報告了SAE。2名(9.5%)患者報告了導致停藥的不良事件。7名患者因疾病進展以外的原因退出研究。
HMPL-523 是一種新型、強效且高選擇性的研究性小分子靶向脾酪氨酸激(酉每)(Syk)的口服抑制劑。Syk作爲B細胞信號傳導通路中的一個關鍵蛋白,是多種亞型的B細胞淋巴瘤及自身免疫疾病的成熟治療靶點。
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