Affimed Reports Phase 1 Efficacy And Safety Data For AFM28 In Relapsed/Refractory Acute Myeloid Leukemia; AFM28, A Bispecific, Tetravalent Innate Cell Engager Targeting CD123 And CD16A, Achieved A 40% Composite Complete Remission Rate At The Highest...
Affimed Reports Phase 1 Efficacy And Safety Data For AFM28 In Relapsed/Refractory Acute Myeloid Leukemia; AFM28, A Bispecific, Tetravalent Innate Cell Engager Targeting CD123 And CD16A, Achieved A 40% Composite Complete Remission Rate At The Highest...
Affimed Reports Phase 1 Efficacy And Safety Data For AFM28 In Relapsed/Refractory Acute Myeloid Leukemia; AFM28, A Bispecific, Tetravalent Innate Cell Engager Targeting CD123 And CD16A, Achieved A 40% Composite Complete Remission Rate At The Highest Dose Level In Heavily Pretreated R/R AML Patients
Affimed报告了AFM28在复发/难治性急性髓性白血病中的第一阶段疗效与安全性数据；AFM28是一种双特异性、四价的先天细胞连接剂，靶向CD123和CD16A，在重度预处理的复发/难治性AML患者中，最高剂量水平达到了40%的综合完全缓解率。
- AFM28, a bispecific, tetravalent innate cell engager (ICE) targeting CD123 and CD16A, achieved a 40% composite complete remission rate (CRcR) at the highest dose level (300 mg) in heavily pretreated R/R AML patients
- AFM28 demonstrates a favorable safety profile: Grade 1 and 2 Infusion related reactions (IRRs) were the main related side effect, occurring in 45% of patients; no signs of neurotoxicity or immune-related side effects were observed
- Based on the good safety profile and likely dose-effect relationship, the evaluation of higher dose levels is planned
- AFM28是一种双特异性、四价的先天细胞连接剂（ICE），靶向CD123和CD16A，在重度预处理的复发/难治性AML患者中，最高剂量水平（300毫克）达到了40%的综合完全缓解率（CRcR）。
- AFM28展示了良好的安全性：1级和2级输注相关反应（IRRs）是主要的不良反应，发生在45%的患者中；未观察到神经毒性或免疫相关不良反应的迹象。
- 基于良好的安全性和可能的剂量-效应关系，计划评估更高剂量水平。
MANNHEIM, Germany, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (NASDAQ:AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the oral presentation of data on AFM28 at the 66th ASH Annual Meeting and Exposition. The data, derived from the first-in-human Phase 1 study of AFM28, showed promising results in R/R AML, with signs of clinical efficacy and a well-managed safety profile at doses up to 300 mg weekly.
德国曼海姆，2024年12月09日（环球新闻）—— Affimed N.V.（纳斯达克：AFMD）（"Affimed"或"公司"），一家致力于让患者恢复抗癌的先天能力的临床阶段免疫肿瘤学公司，今天在第66届ASH年会和博览会上宣布了关于AFM28数据的口头报告。该数据来自AFM28的首次人类1期研究，显示出在复发/难治性AML中的良好结果，表现出了临床疗效的迹象，以及在每周高达300毫克的剂量下良好的安全性。
The study included 29 heavily pretreated R/R AML patients across six AFM28 dose levels. The median number of prior treatment lines was two and 86% of patients had an adverse risk profile according to the 2022 guidelines from the European LeukemiaNet (ELN2022). AFM28 was administered intravenously once a week across six dose levels, ranging from 25 mg to 300 mg. AFM28 was well tolerated, and the most common treatment-emergent adverse events were IRRs, observed in 45% of patients. All IRRs were mild to moderate (Grade 1 or 2). One patient demonstrated grade 1 cytokine release syndrome (CRS). No neurotoxicity or signs for immune-effector related side effects were seen.
该研究纳入了29名重度预处理的复发/难治性AML患者，涉及六个AFM28剂量水平。先前治疗线的中位数为两条，86%的患者根据2022年欧洲白血病网络（ELN2022）指南具有不良风险特征。AFM28以静脉注射方式每周给药一次，剂量范围从25毫克到300毫克。AFM28耐受性良好，最常见的治疗相关不良事件是IRRs，发生在45%的患者中。所有IRRs均为轻度到中度（1级或2级）。一名患者表现出1级细胞因子释放综合症（CRS）。未见神经毒性或免疫效应相关不良反应的迹象。
One of six patients treated at 250 mg showed a CR and stayed on treatment for 6.5 months. At the 300 mg dose level, 1 CR and 3 CRi were seen in 10 evaluable patients for a CRcR of 40%. Four of 10 patients are still on treatment with the option to deepen responses.
在250毫克剂量下治疗的六名患者中，有一名患者显示完全缓解（CR），并持续治疗了6.5个月。在300毫克剂量水平上，10名可评估患者中观察到1例完全缓解（CR）和3例部分缓解（CRi），完全缓解率为40%。10名患者中有四名仍在接受治疗，并有机会加深反应。
