Affimed Shows Higher Exposure of AFM24 is Associated with Significantly Higher Response Rates and Progression-Free Survival in Refractory NSCLC Patients at AACR Annual Meeting
Affimed presented promising results for its cancer drug AFM24 in treating non-small cell lung cancer (NSCLC) at the 2025 AACR Annual Meeting. The study analyzed 72 NSCLC patients, revealing significantly better outcomes in patients with higher drug exposure.
Key findings show patients with above-median drug exposure achieved:
- 33.3% objective response rate vs 5.6% in low-exposure group
- 7.3 months progression-free survival vs 2.9 months
- 83.3% disease control rate vs 58.3%
Based on these results, Affimed will optimize future trials using a higher 720mg weekly dose, which achieves target exposure levels by week two of treatment. Importantly, higher exposure showed no increased safety concerns. The combination therapy with atezolizumab showed consistent benefits, with 37.04% response rate in high-exposure patients versus 7.14% in low-exposure groups.
Affimed ha presentato risultati promettenti per il suo farmaco oncologico AFM24 nel trattamento del carcinoma polmonare non a piccole cellule (NSCLC) durante il Congresso Annuale AACR 2025. Lo studio ha coinvolto 72 pazienti con NSCLC, evidenziando risultati significativamente migliori nei pazienti con un'esposizione al farmaco più elevata.
I principali risultati mostrano che i pazienti con esposizione al farmaco superiore alla mediana hanno raggiunto:
- 33,3% di tasso di risposta obiettiva rispetto al 5,6% nel gruppo a bassa esposizione
- 7,3 mesi di sopravvivenza libera da progressione rispetto a 2,9 mesi
- 83,3% di tasso di controllo della malattia rispetto al 58,3%
In base a questi dati, Affimed ottimizzerà i futuri trial utilizzando una dose settimanale più alta di 720 mg, che consente di raggiungere i livelli target di esposizione entro la seconda settimana di trattamento. È importante sottolineare che un'esposizione maggiore non ha comportato un aumento delle problematiche di sicurezza. La terapia combinata con atezolizumab ha mostrato benefici costanti, con un tasso di risposta del 37,04% nei pazienti ad alta esposizione rispetto al 7,14% nei gruppi a bassa esposizione.
Affimed presentó resultados prometedores para su medicamento contra el cáncer AFM24 en el tratamiento del cáncer de pulmón no microcítico (NSCLC) durante la Reunión Anual AACR 2025. El estudio analizó a 72 pacientes con NSCLC, mostrando resultados significativamente mejores en aquellos con mayor exposición al fármaco.
Los hallazgos clave indican que los pacientes con exposición al fármaco por encima de la mediana lograron:
- 33,3% de tasa de respuesta objetiva frente al 5,6% en el grupo de baja exposición
- 7,3 meses de supervivencia libre de progresión frente a 2,9 meses
- 83,3% de tasa de control de la enfermedad frente al 58,3%
Con base en estos resultados, Affimed optimizará futuros ensayos usando una dosis semanal más alta de 720 mg, que alcanza los niveles objetivo de exposición para la segunda semana de tratamiento. Es importante destacar que una mayor exposición no mostró un aumento en los problemas de seguridad. La terapia combinada con atezolizumab mostró beneficios consistentes, con una tasa de respuesta del 37,04% en pacientes con alta exposición frente al 7,14% en grupos de baja exposición.
Affimed는 2025년 AACR 연례회의에서 비소세포폐암(NSCLC) 치료를 위한 암 치료제 AFM24의 유망한 결과를 발표했습니다. 연구는 72명의 NSCLC 환자를 분석했으며, 약물 노출량이 높은 환자에서 현저히 더 나은 결과가 나타났습니다.
주요 결과에 따르면, 중간값 이상의 약물 노출을 보인 환자들은 다음과 같은 성과를 보였습니다:
- 낮은 노출 그룹의 5.6%에 비해 33.3%의 객관적 반응률
- 2.9개월에 비해 7.3개월의 무진행 생존 기간
- 58.3%에 비해 83.3%의 질병 조절률
이 결과를 바탕으로 Affimed는 향후 임상시험에서 주당 720mg의 더 높은 용량을 사용해 치료 2주 차에 목표 노출 수준에 도달할 계획입니다. 중요한 점은 높은 노출이 안전성 문제를 증가시키지 않았다는 것입니다. 아테졸리주맙과의 병용 요법은 일관된 이점을 보였으며, 고노출 환자에서 37.04%의 반응률을, 저노출 그룹에서는 7.14%를 기록했습니다.
Affimed a présenté des résultats prometteurs pour son médicament anticancéreux AFM24 dans le traitement du cancer du poumon non à petites cellules (NSCLC) lors de la réunion annuelle AACR 2025. L'étude a analysé 72 patients atteints de NSCLC, révélant des résultats nettement meilleurs chez les patients présentant une exposition plus élevée au médicament.
Les résultats clés montrent que les patients avec une exposition au médicament supérieure à la médiane ont obtenu :
- 33,3 % de taux de réponse objective contre 5,6 % dans le groupe à faible exposition
- 7,3 mois de survie sans progression contre 2,9 mois
- 83,3 % de taux de contrôle de la maladie contre 58,3 %
Sur la base de ces résultats, Affimed optimisera les essais futurs en utilisant une dose hebdomadaire plus élevée de 720 mg, atteignant les niveaux d'exposition cibles dès la deuxième semaine de traitement. Il est important de noter qu'une exposition plus élevée n'a pas entraîné de problèmes de sécurité accrus. La thérapie combinée avec l'atezolizumab a montré des bénéfices constants, avec un taux de réponse de 37,04 % chez les patients à forte exposition contre 7,14 % dans les groupes à faible exposition.
Affimed präsentierte vielversprechende Ergebnisse für sein Krebsmedikament AFM24 zur Behandlung von nicht-kleinzelligem Lungenkrebs (NSCLC) auf dem AACR-Jahrestreffen 2025. Die Studie analysierte 72 NSCLC-Patienten und zeigte deutlich bessere Ergebnisse bei Patienten mit höherer Medikamentenexposition.
Wesentliche Ergebnisse zeigen, dass Patienten mit über dem Median liegender Medikamentenexposition folgende Werte erreichten:
- 33,3% objektive Ansprechrate gegenüber 5,6% in der Niedrig-Expositionsgruppe
- 7,3 Monate progressionsfreies Überleben gegenüber 2,9 Monaten
- 83,3% Krankheitskontrollrate gegenüber 58,3%
Basierend auf diesen Ergebnissen wird Affimed zukünftige Studien mit einer höheren wöchentlichen Dosis von 720 mg optimieren, die die Ziel-Expositionswerte bis zur zweiten Behandlungswoche erreicht. Wichtig ist, dass die höhere Exposition keine erhöhten Sicherheitsbedenken zeigte. Die Kombinationstherapie mit Atezolizumab zeigte konsistente Vorteile, mit einer Ansprechrate von 37,04% bei Patienten mit hoher Exposition gegenüber 7,14% in der Niedrig-Expositionsgruppe.
- Higher AFM24 drug exposure shows 33.3% vs 5.6% objective response rate in NSCLC patients
- Improved progression-free survival of 7.3 months vs 2.9 months in high-exposure group
- Higher exposure shows no increased safety risks or severe adverse events
- Combination therapy with atezolizumab shows 37.04% response rate in high-exposure group
- 720mg weekly dose (higher dose) already proven safe in phase 1 trials
- Overall survival data not yet mature in high-exposure group
- Low exposure group shows poor response rate of only 5.6%
- Early tumor progression risk in low exposure group could affect treatment outcomes
Insights
AFM24's higher exposure shows 6-fold better response rates in NSCLC without increasing toxicity, justifying dose optimization to 720mg for future trials.
The exposure-outcome analysis of AFM24 in 72 refractory NSCLC patients demonstrates a clear dose-response relationship with significant clinical implications. Patients achieving higher drug exposure showed a remarkable 33.3% objective response rate versus just 5.6% (p=0.0059) in the low-exposure group - a six-fold improvement. The disease control rate also significantly improved (83.3% vs 58.3%, p=0.0367), as did progression-free survival (7.33 vs 2.86 months).
The quartile analysis further validates this relationship, with response rates increasing stepwise from 0% to 50% across exposure levels. This is compelling evidence that maintaining higher drug concentrations is critical for efficacy. The subgroup analysis of 55 patients receiving AFM24 plus atezolizumab showed consistent results (37.04% vs 7.14% ORR), suggesting the exposure-efficacy relationship holds across treatment approaches.
Crucially, these improved outcomes occurred without increasing the rate of adverse events, indicating an expanded therapeutic window. For NSCLC patients with limited options, this data supports the development of a chemotherapy-free immunotherapy approach targeting EGFR via innate immune cell engagement.
The planned dose escalation to 720mg is scientifically sound, as pharmacokinetic modeling shows this achieves target exposure by week two - potentially preventing the early progression risk observed in low-exposure patients. This optimization represents a significant advancement for this hard-to-treat population.
Affimed's dose-optimization data for AFM24 shows clear exposure-efficacy relationship, creating a rational pathway to improved outcomes in difficult-to-treat NSCLC.
This post-hoc exposure-response analysis provides critical insights that could meaningfully enhance AFM24's clinical utility. The statistically significant correlations between drug exposure and multiple efficacy endpoints (p=0.0059 for ORR, p=0.0367 for DCR) offer a strong scientific rationale for dose optimization in Affimed's development program.
The data reveals a consistent relationship between exposure and clinical benefit, with the highest exposure quartile achieving 50% response rates compared to 0% in the lowest quartile. This robust dose-response relationship validates Affimed's mechanistic approach with their innate cell engager platform in solid tumors.
By identifying that insufficient drug exposure increases the risk of early tumor progression, Affimed has pinpointed a key limitation in their current dosing strategy. The pharmacokinetic modeling suggesting that 720mg weekly dosing achieves target exposure levels by week two represents a rational, data-driven solution to this challenge.
Importantly, the safety profile remained consistent across exposure levels, indicating the 720mg dose (previously established as safe in phase 1) should maintain the favorable benefit-risk profile while improving efficacy outcomes.
This optimization approach demonstrates sound clinical development strategy, potentially transforming a promising but variably effective therapy into one with more consistent benefit. For NSCLC patients, who face limited treatment options, these refinements could translate to meaningful improvements in real-world outcomes with this novel immune-engaging approach.
- An exposure-outcome analysis in 72 patients with refractory non-small cell lung cancer (NSCLC) who received AFM24 at 480 mg weekly demonstrates that higher drug exposure (above median) leads to improved objective response rate (
33.3% vs5.6% ) and longer progression free survival (PFS) (7.3 mo. vs 2.9 mo.) without a negative impact on safety - These findings will be incorporated in future AFM24 trials to further improve efficacy outcomes of patients treated with AFM24
MANNHEIM, Germany, April 29, 2025 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today presented findings on an exposure-outcome analysis of its innate cell engager (ICE®) AFM24, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) in a poster session at the 2025 Annual Meeting of the American Association for Cancer Research (AACR).
The analysis is based on post-hoc exposure-response data from 72 NSCLC patients treated with 480 mg of AFM24 monotherapy or a combination of AFM24 with atezolizumab. For all patients, trough levels over time were used to calculate the patient’s mean exposure to AFM24. Patients were then split into high and low AFM24 exposure groups for the analysis using the respective median as a cut-off.
Key Findings from the Exposure-Response Analysis
- Objective Response Rate (ORR):
33.3% in the high-exposure group vs.5.6% in the low-exposure group (p=0.0059) - Disease Control Rate (DCR):
83.3% vs.58.3% (p=0.0367) - Median Progression-Free Survival (mPFS): 7.33 vs. 2.86 months
- Overall Survival (OS): Not yet mature in the high-exposure group vs. 13 months in the low-exposure group
A quartile analysis further confirmed the exposure-efficacy relationship, showing a stepwise increase in ORR from
“Advanced NSCLC is a devastating disease and remains an area of high unmet need,” said Andreas Harstrick, MD, Chief Medical Officer of Affimed. “These findings strengthen our clinical rationale for dose optimization and highlight the potential of AFM24 – particularly in combination with atezolizumab – as a novel, chemotherapy-free, immunotherapy-based treatment approach. Importantly, the data suggest that achieving higher drug exposure early in treatment may prevent rapid disease progression.”
Further Development
Pharmacokinetic (PK) modeling indicates that a 720 mg weekly dose of AFM24—previously established as safe—achieves target exposure levels by the second week of treatment that correspond to the high exposure group in the post-hoc analysis. Based on these findings, Affimed will include the 720 mg dose moving forward to optimize clinical benefit and reduce early progression risk.
“These data provide compelling evidence that higher exposure may translate to better outcomes in patients with advanced NSCLC,” Dr. Harstrick added. “With dose optimization in hand, we are positioned to advance AFM24 in its potential to deliver durable benefit in a difficult-to-treat patient population.”
Conclusions
The data show a strong correlation between exposure and clinical outcome with a significantly increased risk for early tumor progression in the low exposure group. PK modeling suggests that a dose of 720 mg AFM24 weekly will result in exposure levels exceeding the cutoff for the high exposure group as early as week two. The 720 mg dose, which has already been established as safe in the phase 1 trial, will be used in future AFM24 studies.
More details about the programs for the AACR Annual Meeting 2025 are available online at AACR Annual Meeting 2025 | Meetings | AACR.
About AFM24
AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.
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.
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