和黃醫藥(00013.HK)與信達生物宣佈呋喹替尼(fruquintinib)聯合信迪利單抗(sintilimab)用於治療晚期腎細胞癌的FRUSICA-2中國II/III期研究達到主要終點
格隆匯3月19日丨和黃醫藥(00013.HK)和信達生物今日聯合宣佈呋喹替尼 (fruquintinib)和信迪利單抗 (sintilimab)聯合療法用於二線治療局部晚期或轉移性腎細胞癌的FRUSICA-2中國II/III期研究已達到盲態獨立中心閱片(BICR)根據 RECIST 1.1標準評估的無進展生存期(“PFS”)的主要終點。
呋喹替尼和信迪利單抗的聯合療法早前已基於FRUSICA-1研究的數據取得中國國家藥品監督管理局(“國家藥監局”)附條件批準，用於治療既往系統性抗腫瘤治療後失敗且不適合進行根治性手術治療或根治性放療的晚期錯配修復完整(pMMR)的子宮內膜癌患者(NCT03903705)。
FRUSICA-2研究是一項隨機、開放標籤、陽性對照的臨牀試驗，旨在評估呋喹替尼和信迪利單抗聯合療法對比阿昔替尼(axitinib)或依維莫司(everolimus)單藥療法用於二線治療晚期腎細胞癌的療效和安全性 (NCT05522231) 。除了主要終點PFS外，該聯合療法在包括客觀緩解率(“ORR”)和緩解持續時間(“DoR”)在內的次要終點上亦取得改善。完整的研究數據將提交於近期的學術會議上發表。
FRUSICA-2研究的聯合主要研究者 、復旦大學附屬腫瘤醫院葉定偉教授表示： “靶向治療、免疫治療以及其聯合療法方案的快速發展爲晚期腎細胞癌的治療格局帶來重大變化。在晚期腎細胞癌系統性治療中，靶向治療仍然是不可或缺的重要手段。對於不同的患者個體，如何合理地選擇靶向治療或靶免聯合治療，成爲臨牀關注的熱點。 FRUSICA-2研究的結果凸顯了呋喹替尼和信迪利單抗聯合療法在解決這種具有挑戰性的疾病患者的迫切醫療需求方面的潛力。”
FRUSICA-2研究的聯合主要研究者 、北京大學第一醫院何志嵩教授表示： “呋喹替尼和信迪利單抗聯合療法的 III 期研究取得積極結果，這是晚期腎細胞癌治療領域一項重要的突破。我們致力爲對現有治療反應不佳的患者提供更多有效的治療選擇，我們對此項發現可能爲臨牀實踐帶來的變革充滿信心。”
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