港股異動 | 再鼎醫藥-SB盤中漲超25%,合作夥伴肺癌治療設備前景光明
uSMART盈立智投4月14日消息,週三港股早盤,再鼎醫藥-SB高開高走,截至9:53,再鼎醫藥-SB盤中一度漲超25%,創2020年上市以來最大漲幅。
週二美股,再鼎醫藥收漲22.14%,合作夥伴Novocure收漲49.63%創新高;此前兩家公司共同宣佈在第IV期非小細胞肺癌關鍵腫瘤治療領域的III期臨牀試驗取得了積極結果。
在獨立數據監察委員會(DMC)對研究進行例行審查後,Novocure被告知,基於目前入組時間和觀察到的事件數量,LUNAR研究預先設定的中期分析將被加快。LUNAR研究的中期分析包括了累積到2021年2月的210名患者數據。在審查了中期分析報告後,DMC表示沒有證據表明腫瘤電場治療會增加系統性毒性,LUNAR研究應該繼續開展。
DMC還指出,繼續招募患者直至534例,對隨機分配到對照組且進行18個月隨訪的患者來說,可能是不必要且不符合醫學倫理的。DMC建議研究樣本量減少至276例,並將隨訪時間縮短至12個月,這樣同樣能爲研究的主要終點和次要終點提供足夠的統計效能。除此之外,DMC沒有對LUNAR研究的設計提出其他意見。目前,所有數據對Novocure仍處於保密狀態。
LUNAR研究的主要終點是使用TTFields聯合免疫檢查點抑制劑或者聯合多西他賽治療的患者總生存期 (OS) 優於單獨使用免疫檢查點抑制劑或者多西他賽的患者。最終分析還將包括對免疫檢查點抑制劑和多西他賽亞組的總生存分析。
Novocure已就DMC的建議通知美國食品藥品監督管理局 (FDA),並表示將會把DMC所建議的調整方案整合進器械豁免研究 (IDE) 補充材料進行提交。
Guggenheim將再鼎醫藥ADR的目標價由165美元上調至250美元。
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