Affimed Reports Promising Phase 1 Efficacy and Safety Data for AFM28 in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Affimed announced promising Phase 1 data for AFM28 in treating relapsed/refractory Acute Myeloid Leukemia (R/R AML). The study, involving 29 heavily pretreated patients, demonstrated a 40% composite complete remission rate at the highest dose level (300 mg). Key findings include:
- Well-managed safety profile with mainly Grade 1 and 2 infusion-related reactions in 45% of patients
- No neurotoxicity or immune-related side effects
- One complete remission at 250 mg dose level with 6.5-month treatment duration
- At 300 mg dose level, achieved 1 CR and 3 CRi in 10 evaluable patients
The study included patients with a median of two prior treatment lines, with 86% having adverse risk profiles. Based on these results, evaluation of higher dose levels is planned.
Affimed ha annunciato dati promettenti della Fase 1 per AFM28 nel trattamento della Leucemia Mieloide Acuta (LMA) recidivante/refrattaria. Lo studio, che ha coinvolto 29 pazienti fortemente pretrattati, ha dimostrato un tasso di remissione completa composita del 40% al livello di dose più alto (300 mg). Risultati chiave includono:
- Profilo di sicurezza ben gestito con principalmente reazioni infusionale di Grado 1 e 2 nel 45% dei pazienti
- Assenza di neurotossicità o effetti collaterali immunologici
- Una remissione completa al livello di dose di 250 mg con una durata del trattamento di 6,5 mesi
- Al livello di 300 mg, raggiunto 1 CR e 3 CRi in 10 pazienti valutabili
Lo studio ha incluso pazienti con una mediana di due linee di trattamento precedenti, con l'86% aventi profili di rischio avverso. Sulla base di questi risultati, è prevista una valutazione di livelli di dose più elevati.
Affimed anunció datos prometedores de fase 1 para AFM28 en el tratamiento de la leucemia mieloide aguda (LMA) recaída/refractaria. El estudio, que involucra a 29 pacientes con mucha experiencia previa en tratamientos, demostró una tasa de remisión completa compuesta del 40% en el nivel de dosis más alto (300 mg). Hallazgos clave incluyen:
- Perfil de seguridad bien gestionado con principalmente reacciones relacionadas con la infusión de grado 1 y 2 en el 45% de los pacientes
- Sin neurotoxicidad ni efectos secundarios relacionados con el sistema inmune
- Una remisión completa al nivel de dosis de 250 mg con una duración de tratamiento de 6,5 meses
- En el nivel de 300 mg, se logró 1 CR y 3 CRi en 10 pacientes evaluables
El estudio incluyó pacientes con una mediana de dos líneas de tratamiento previas, con el 86% con perfiles de riesgo adversos. Basado en estos resultados, se planea evaluar niveles de dosis más altos.
Affimed는 재발성/약물내성 급성 골수 백혈병(R/R AML) 치료를 위한 AFM28의 유망한 1상 데이터를 발표했습니다. 29명의 심각하게 치료 받은 환자가 포함된 이 연구는 최고 용량 수준(300 mg)에서 40%의 완전 관해 복합 비율을 보여주었습니다. 주요 발견은 다음과 같습니다:
- 45%의 환자에서 주로 1등급 및 2등급 주입 관련 반응으로 잘 관리된 안전성 프로필
- 신경 독성이나 면역 관련 부작용 없음
- 250 mg 용량 수준에서 6.5개월의 치료 기간 동안 1건의 완전 관해
- 300 mg 용량 수준에서, 10명의 평가 가능한 환자에서 1 CR 및 3 CRi 도달
이 연구에는 두 개의 이전 치료 라인이 있는 환자가 포함되었으며, 86%는 불리한 위험 프로필을 가졌습니다. 이러한 결과를 바탕으로, 더 높은 용량 수준의 평가가 계획되어 있습니다.
Affimed a annoncé des données prometteuses de phase 1 pour AFM28 dans le traitement de la Leucémie Myeoloïde Aigue (LMA) récurrente/réfractaire. L'étude, impliquant 29 patients ayant subi de nombreux traitements, a démontré un taux de rémission complète composite de 40% au niveau de dose le plus élevé (300 mg). Résultats clés incluent:
- Profil de sécurité bien géré avec principalement des réactions liées à l'infusion de grade 1 et 2 chez 45% des patients
- Pas de neurotoxicité ou d'effets secondaires liés au système immunitaire
- Une rémission complète au niveau de dose de 250 mg avec une durée de traitement de 6,5 mois
- Au niveau de 300 mg, 1 CR et 3 CRi ont été atteints chez 10 patients évaluables
L'étude a inclus des patients ayant une médiane de deux lignes de traitement antérieures, avec 86% ayant des profils de risque défavorables. Sur la base de ces résultats, une évaluation de niveaux de doses plus élevés est prévue.
Affimed hat vielversprechende Phase-1-Daten für AFM28 zur Behandlung von rezidivierender/refraktärer akuter myeloischer Leukämie (R/R AML) angekündigt. In der Studie, an der 29 stark vorbehandelte Patienten teilnahmen, wurde eine 40%ige Rate an vollständiger Komplettrémission auf der höchsten Dosisstufe (300 mg) nachgewiesen. Wichtige Ergebnisse umfassen:
- Gut verwaltetes Sicherheitsprofil mit hauptsächlich Grad-1- und Grad-2-Infusionsreaktionen bei 45% der Patienten
- Keine Neurotoxizität oder nebenwirkungen, die mit dem Immunsystem zusammenhängen
- Eine vollständige Remission auf der 250 mg Dosisstufe mit einer Behandlungsdauer von 6,5 Monaten
- Auf der 300 mg Dosisstufe wurden 1 CR und 3 CRi bei 10 bewertbaren Patienten erreicht
Die Studie umfasste Patienten mit einer Median von zwei vorherigen Behandlungslinien, von denen 86% ein nachteiliges Risikoprofil hatten. Basierend auf diesen Ergebnissen ist eine Bewertung höherer Dosisniveaus geplant.
- 40% composite complete remission rate achieved at 300 mg dose level
- Favorable safety profile with only mild to moderate side effects
- Clinical efficacy demonstrated in heavily pretreated patients
- Four of 10 patients still on treatment with potential for deeper responses
- Only 40% response rate at highest dose level, leaving majority of patients unresponsive
- 45% of patients experienced infusion-related reactions
- duration of response data available
Insights
- 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
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.
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
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
“Achieving a
The AFM28 Phase 1 study is on-going.
About AFM28
AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE®, is designed to bring our immunotherapeutic approach to patients with acute myeloid leukemia (AML). It engages NK cells to initiate leukemic cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. AFM28 is currently in clinical development as monotherapy in patients with R/R AML (NCT05817058).
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates; the value of its ROCK® platform; its ongoing and planned clinical trials; its corporate restructuring, the associated headcount reduction and the impact this may have on Company’s anticipated savings and total costs and expenses; its collaborations and development of its products in combination with other therapies; the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates; its intellectual property position; its collaboration activities; its ability to develop commercial functions; clinical trial data; its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which it operates; the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023; impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation; the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; the fact that the current clinical data of acimtamig in combination with NK cell therapy is based on acimtamig precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101; and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Affimed Investor Relations Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
Affimed Media Contact
Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
FAQ
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