Fusion Pharmaceuticals Announces First Patient Dosed In The Phase 2 Portion Of The AlphaBreak Trial Evaluating FPI-2265 In Metastatic Castration-Resistant Prostate Cancer
Fusion Pharmaceuticals Announces First Patient Dosed In The Phase 2 Portion Of The AlphaBreak Trial Evaluating FPI-2265 In Metastatic Castration-Resistant Prostate Cancer
AlphaBreak is a Phase 2/3 registrational program for FPI-2265 in patients with metastatic castration-resistant prostate cancer
AlphaBreak 是一項針對轉移性去勢耐藥性前列腺癌患者的 FPI-2265 的 2/3 期註冊計劃
HAMILTON, ON and BOSTON, May 9, 2024 /CNW/ -- Fusion Pharmaceuticals Inc. (NASDAQ:FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, today announced that the first patient has been dosed in the Phase 2 portion of the AlphaBreak trial evaluating FPI-2265 (225Ac-PSMA I&T) in patients with metastatic castration-resistant prostate cancer (mCRPC).
安大略省漢密爾頓和波士頓，2024年5月9日 /CNW/ — 專注於開發下一代放射性偶聯物（RC）作爲精準藥物的臨床階段腫瘤公司Fusion Pharmicals Inc.（納斯達克股票代碼：FUSN）今天宣佈，在評估轉移性去勢抵抗性前列腺癌患者的 FPI-2265（225ac-pSMA I&T）的AlphaBreak試驗的第二階段中，第一位患者已服藥 (mcRPC)。
"Actinium-based PSMA targeting RCs have demonstrated compelling safety and clinical activity, which is supported by Fusion's encouraging data from the Phase 2 TATCIST trial reported recently at the AACR Annual Meeting. We believe FPI-2265 represents an important potential new treatment option for patients with mCRPC, and with the initiation of the AlphaBreak trial we are pleased to move forward," said Chief Medical Officer Dmitri Bobilev, M.D.
“基於Actinium的PSMA靶向RC已顯示出令人信服的安全性和臨床活性，Fusion最近在AACR年會上公佈的2期TATCIST試驗中令人鼓舞的數據支持了這一點。我們認爲，對於mcRPC患者來說，FPI-2265 是一種重要的潛在新治療選擇，隨着AlphaBreak試驗的啓動，我們很高興向前邁進。” 首席醫學官德米特里·博比列夫醫學博士說。
"Despite recent advances in the field, we see many patients with mCRPC still in need of additional treatment options, especially after progressing on lutetium-based radiotherapy. It is encouraging to see the promising clinical activity and good safety profile demonstrated by FPI-2265. The initiation of the AlphaBreak trial brings us a step closer to addressing the gap for patients and providing this needed treatment option," said investigator Luke Nordquist, M.D., FACP, XCancer Chief Executive Officer.
“儘管該領域最近取得了進展，但我們看到許多mcRPC患者仍然需要額外的治療選擇，尤其是在基於黃體的放射治療取得進展之後。令人鼓舞的是，FPI-2265 顯示出令人鼓舞的臨床活性和良好的安全性。AlphaBreak試驗的啓動使我們離解決患者差距和提供這種所需的治療選擇又近了一步。” 研究人員、FACP醫學博士、xCancer首席執行官盧克·諾德奎斯特說。
The AlphaBreak trial is a Phase 2/3, randomized, open-label, multicenter study to evaluate the safety and efficacy of FPI-2265 in patients with mCRPC previously treated with 177Lu-PSMA radiotherapy. The Phase 2 dose optimization portion is designed to evaluate whether there are added safety and/or efficacy benefits of two alternative dosing regimens in comparison to the previously studied regimen of 100 kBq/kg every eight weeks. The Phase 2 portion of the AlphaBreak trial is expected to complete enrollment of approximately 60 patients by the end of 2024. Following analysis of the Phase 2 data and an end of Phase 2 meeting to determine the recommended Phase 3 dosing regimen with the U.S. Food and Drug Administration (FDA), the Phase 3 global registration portion of the AlphaBreak trial will enroll approximately 550 patients and is expected to begin in 2025.
AlphaBreak 試驗是一項 2/3 期隨機、開放標籤、多中心研究，旨在評估 FPI-2265 對先前接受過 177lu-pSMA 放射治療的 mcRPC 患者的安全性和有效性。第二階段劑量優化部分旨在評估與先前研究的每八週100 kbq/kg的方案相比，兩種替代給藥方案是否具有額外的安全性和/或有效性益處。預計到2024年底，AlphaBreak試驗的第二階段將完成約60名患者的入組。在分析了2期數據並結束了與美國食品藥品監督管理局（FDA）舉行的確定推薦的3期給藥方案的第二階段會議之後，AlphaBreak試驗的第三階段全球註冊部分將招收約550名患者，預計將於2025年開始。
譯文內容由第三人軟體翻譯。