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報告了AFM28在復發/難治性急性髓性白血病中的第一階段療效與安全性數據；AFM28是一種雙特異性、四價的先天細胞連接劑，靶向CD123和CD16A，在重度預處理的復發/難治性AML患者中，最高劑量水平達到了40%的綜合完全緩解率。
- 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是一種雙特異性、四價的先天細胞連接劑（ICE），靶向CD123和CD16A，在重度預處理的復發/難治性AML患者中，最高劑量水平（300毫克）達到了40%的綜合完全緩解率（CRcR）。
- AFM28展示了良好的安全性：1級和2級輸注相關反應（IRRs）是主要的不良反應，發生在45%的患者中；未觀察到神經毒性或免疫相關不良反應的跡象。
- 基於良好的安全性和可能的劑量-效應關係，計劃評估更高劑量水平。
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.
德國曼海姆，2024年12月09日（環球新聞）—— Affimed N.V.（納斯達克：AFMD）（"Affimed"或"公司"），一家致力於讓患者恢復抗癌的先天能力的臨床階段免疫腫瘤學公司，今天在第66屆ASH年會和博覽會上宣佈了關於AFM28數據的口頭報告。該數據來自AFM28的首次人類1期研究，顯示出在復發/難治性AML中的良好結果，表現出了臨床療效的跡象，以及在每週高達300毫克的劑量下良好的安全性。
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.
該研究納入了29名重度預處理的復發/難治性AML患者，涉及六個AFM28劑量水平。先前治療線的中位數爲兩條，86%的患者根據2022年歐洲白血病網絡（ELN2022）指南具有不良風險特徵。AFM28以靜脈注射方式每週給藥一次，劑量範圍從25毫克到300毫克。AFM28耐受性良好，最常見的治療相關不良事件是IRRs，發生在45%的患者中。所有IRRs均爲輕度到中度（1級或2級）。一名患者表現出1級細胞因子釋放綜合症（CRS）。未見神經毒性或免疫效應相關不良反應的跡象。
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毫克劑量下治療的六名患者中，有一名患者顯示完全緩解（CR），並持續治療了6.5個月。在300毫克劑量水平上，10名可評估患者中觀察到1例完全緩解（CR）和3例部分緩解（CRi），完全緩解率爲40%。10名患者中有四名仍在接受治療，並有機會加深反應。
譯文內容由第三人軟體翻譯。
