ImmunityBio Completes ANKTIVA's Post-Approval Enrollment Of The 100th Patient In BCG Unresponsive NMIBC CIS Trial And Reports A Complete Response Rate Of 71% With A Durable Duration Of Response Ranging Up To 54 Months Reported For 82 Patients...
ImmunityBio Completes ANKTIVA's Post-Approval Enrollment Of The 100th Patient In BCG Unresponsive NMIBC CIS Trial And Reports A Complete Response Rate Of 71% With A Durable Duration Of Response Ranging Up To 54 Months Reported For 82 Patients...
ImmunityBio Completes ANKTIVA's Post-Approval Enrollment Of The 100th Patient In BCG Unresponsive NMIBC CIS Trial And Reports A Complete Response Rate Of 71% With A Durable Duration Of Response Ranging Up To 54 Months Reported For 82 Patients Published In NEJM
ImmunityBio完成了ANKTIVA後批准的10名患者入組BCG不敏感的NMIBC CIS試驗，並報告了71%的完全緩解率，持續緩解期長達54個月，82名患者的結果已在NEJM（《新英格蘭醫學雜誌》）上發表。
- High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled
- Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024
- Complete response data in 100 patients consistent with CR rate of 71% reported for 82 patients published in NEJM
- 在QUILt-3.032中，有高響應率的患者，持續緩解期長達54個月，共有100名患者入組。
- 更新的數據打算作爲2024年第四季度歐洲藥品管理局（EMA）提交的一部分。
- 100名患者的完全緩解數據與NEJM上報道的82名患者的71%緩解率一致。
ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, today announced compelling new data from its ongoing QUILT 3.032 study. As of November 2024, 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (NMIBC CIS) have been treated with ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with BCG, achieving a 71% complete response (CR) rate. In these responders, the range of durable response extended to 54 months. This data update will be submitted to the European Medicines Agency (EMA) in a Marketing Authorization Application (MAA) for ANKTIVA in the European Union (EU), which is anticipated during Q4 2024.
ImmunityBio公司（IBRX），一家領先的免疫治療公司，今天宣佈了其正在進行的QUILt 3.032研究的引人注目的新數據。截至2024年11月，已有100名患有BCG不敏感的非肌肉侵襲性膀胱癌合併原位癌（NMIBC CIS）的患者接受了ANKTIVA（nogapendekin alfa inbakicept-pmln）與BCG的聯合治療，實現了71%的完全緩解率。在這些獲得緩解的患者中，持久緩解的區間延長至54個月。這些數據更新將被提交給歐洲藥品管理局（EMA），用於在歐盟提出ANKTIVA的上市授權申請，預計在2024年第四季度進行。
This significant milestone underscores the potential of ANKTIVA to provide durable responses in patients with limited treatment options. The QUILT 3.032 study is a single-arm, multicenter trial evaluating the safety and efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC CIS. The observed 71% CR rate aligns with previous findings reported in the New England Journal of Medicine (NEJM Evidence, Chamie 2022) and reinforces the therapeutic promise of this combination therapy.
這一重要里程碑凸顯了ANKTIVA在治療選擇有限的患者中提供持久緩解的潛力。QUILt 3.032研究是一項單臂、多中心試驗，評估了在BCG不敏感的NMIBC CIS患者中ANKTIVA與BCG聯合使用的安全性和有效性。觀察到的71%的完全緩解率與《新英格蘭醫學雜誌》（NEJM）中報道的之前研究結果相符，進一步強調了這種聯合療法的治療前景。
譯文內容由第三人軟體翻譯。
