基石藥業(02616.HK)：惰性系統性肥大細胞增生症患者皮膚病變症狀顯著減輕
格隆匯 6 月 17日丨基石藥業－Ｂ(02616.HK)發佈公告，公司的合作伙伴 Blueprint Medicines Corporation (納斯達克股份代號：BPMC)於6月6日公佈了PIONEER臨牀試驗第1部分最新臨牀資料，採用多個皮膚病變相關定性、定量指標評估結果顯示，avapritinib在治療惰性系統性肥大細胞增生症(“ISM”)患者中顯示出可靠、持續的臨牀有效性。
此外，ISM症狀評估表(“ISM-SAF”)總症狀評分(“TSS”)評估顯示，接受avapritinib治療組患者總體疾病症狀改善程度顯著，並於24周隨訪期間耐受良好。上述資料發表於2020年歐洲過敏症和臨牀免疫學會(“EAACI”)數字年會。
系統性肥大細胞增生症(“SM”)是一種罕見疾病，幾乎所有患者具有 KIT D816V 突變、以肥大細胞失控增殖和過度活化為特徵。該病可導致患者全身狀況虛弱、胃腸道和神經認知症狀，包括危及生命的過敏反應。瘙癢、潮紅和色素性皮損等其他皮膚表現常見，可明顯影響生活品質。avapritinib 是針對 KIT-D816V 突變的強效、高選擇性抑制劑。
基石藥業與 Blueprint Medicines 已達成獨家合作和授權協議，推進 pralsetinib、avapritinib 和 fisogatinib在中國內地及香港特別行政區、澳門特別行政區和台灣地區的臨牀開發和商業化進程。Blueprint Medicines 保留對上述三種產品在全球其他國家的開發和商業化權利。
有關重點消息包括：在ISM患者中開展的PIONEER臨牀試驗最新資料顯示，治療24周時，avapritinib組症狀緩解率為60%，安慰劑組為0%，症狀緩解定義為總症狀評分降低≥30%；avapritinib用於晚期SM(“AdvSM”)患者的EXPLORER臨牀試驗最新資料於6月12日在歐洲血液學協會網路視頻年會上發表。
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