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后批准的10名患者入组BCG不敏感的NMIBC CIS试验，并报告了71%的完全缓解率，持续缓解期长达54个月，82名患者的结果已在NEJM（《新英格兰医学杂志》）上发表。
- 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，有高响应率的患者，持续缓解期长达54个月，共有100名患者入组。
- 更新的数据打算作为2024年第四季度欧洲药品管理局（EMA）提交的一部分。
- 100名患者的完全缓解数据与NEJM上报道的82名患者的71%缓解率一致。
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），一家领先的免疫治疗公司，今天宣布了其正在进行的QUILt 3.032研究的引人注目的新数据。截至2024年11月，已有100名患有BCG不敏感的非肌肉侵袭性膀胱癌合并原位癌（NMIBC CIS）的患者接受了ANKTIVA（nogapendekin alfa inbakicept-pmln）与BCG的联合治疗，实现了71%的完全缓解率。在这些获得缓解的患者中，持久缓解的区间延长至54个月。这些数据更新将被提交给欧洲药品管理局（EMA），用于在欧盟提出ANKTIVA的上市授权申请，预计在2024年第四季度进行。
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.
这一重要里程碑凸显了ANKTIVA在治疗选择有限的患者中提供持久缓解的潜力。QUILt 3.032研究是一项单臂、多中心试验，评估了在BCG不敏感的NMIBC CIS患者中ANKTIVA与BCG联合使用的安全性和有效性。观察到的71%的完全缓解率与《新英格兰医学杂志》（NEJM）中报道的之前研究结果相符，进一步强调了这种联合疗法的治疗前景。
