賽生藥業(06600.HK)：RRx-001用於小細胞肺癌三線及以上治療III期臨牀試驗完成中國首例患者給藥
格隆匯9月6日丨賽生藥業(06600.HK)發佈公吿，在研產品RRx-001用於小細胞肺癌三線及以上治療的III期註冊臨牀研究 (REPLATINUM)已於中國完成首例患者給藥。REPLATINUM研究是一項對照、開放、國際隨機化III期研究，在中美同步開展，計劃共入組292例患者，將通過對比含鉑類二聯療法單獨給藥，評估RRx-001與含鉑類二聯療法序貫給藥作為小細胞肺癌三線或後續治療的有效性及安全性。
RRx-001是一款具有First-in-Class(FIC)潛質的小分子藥物，具有多種作用機制，包括CD47- SIRPα靶向、RONS生成以及表觀遺傳調節。RRx-001可以對多種腫瘤微環境異常起到調節作用，包括：下調CD47-SIRPα，使腫瘤相關巨噬細胞(TAM)復極化，由抗炎症M2表型轉為促炎症M1表型；通過表觀遺傳抑制活性激活抑癌基因，逆轉化療耐藥；使腫瘤血管正常化以增加化療藥物滲透，產生代謝產物RONS導致腫瘤細胞壞死。臨牀II期研究數據顯示，RRx-001在小細胞肺癌等實體腫瘤的治療中具有良好的療效和安全性。和現有治療方式相比，RRx-001顯示出潛在提升患者生存獲益的可能性。
REPLATINUM研究全球主要研究者、中山大學腫瘤防治中心腫瘤內科主任張力教授表示，“全球範圍內小細胞肺癌治療存在巨大未被滿足的需求，臨牀亟需更多有效的治療選擇。現有研究數據表明，RRx-001能夠逆轉化療耐藥，使腫瘤對鉑類療法重新敏感化，且具有良好的安全性。我們期待REPLATINUM研究能取得積極結果，從而使SCLC患者有機會從新的治療選擇中獲益。”
在中國完成首例患者給藥，是REPLATINUM研究的一個重要進展。公司期待RRx-001 這一款具有FIC潛質的及多種作用機制的小分子創新藥能夠推進全球SCLC的臨牀治療進程，為患者帶來新的選擇。
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