Affimed Reports Positive Clinical Update on AFM24/Atezolizumab Combination Therapy in Non-Small Cell Lung Cancer (NSCLC)
Affimed (AFMD) reported positive clinical data from the AFM24-102 trial combining AFM24 with atezolizumab in non-small cell lung cancer (NSCLC) patients. In 33 EGFR wild-type patients, the combination showed a 21% overall response rate and 76% disease control rate, with tumor shrinkage in 48% of patients. The median progression-free survival was 5.6 months.
In 17 EGFR mutant patients, results showed a 24% overall response rate and 71% disease control rate, with tumor shrinkage in 41% of patients. Both patient groups demonstrated manageable side effects. A post-hoc analysis revealed that patients with higher AFM24 exposure had significantly better outcomes, leading to plans for using a higher 720mg weekly dose in future development.
Affimed (AFMD) ha riportato dati clinici positivi dallo studio AFM24-102 che combina AFM24 con atezolizumab in pazienti con carcinoma polmonare non a piccole cellule (NSCLC). In 33 pazienti con tipo selvatico EGFR, la combinazione ha mostrato un 21% di tasso di risposta globale e un 76% di tasso di controllo della malattia, con riduzione del tumore nel 48% dei pazienti. La mediana di sopravvivenza libera da progressione è stata di 5,6 mesi.
In 17 pazienti con mutazione EGFR, i risultati hanno mostrato un 24% di tasso di risposta globale e un 71% di tasso di controllo della malattia, con riduzione del tumore nel 41% dei pazienti. Entrambi i gruppi di pazienti hanno dimostrato effetti collaterali gestibili. Un'analisi post-hoc ha rivelato che i pazienti con maggiore esposizione ad AFM24 avevano risultati significativamente migliori, portando a piani per utilizzare una dose settimanale più elevata di 720 mg nello sviluppo futuro.
Affimed (AFMD) reportó datos clínicos positivos del ensayo AFM24-102 que combina AFM24 con atezolizumab en pacientes con cáncer de pulmón no microcítico (NSCLC). En 33 pacientes con tipo salvaje EGFR, la combinación mostró un 21% de tasa de respuesta global y un 76% de tasa de control de la enfermedad, con reducción tumoral en el 48% de los pacientes. La mediana de supervivencia libre de progresión fue de 5.6 meses.
En 17 pacientes con mutación EGFR, los resultados mostraron un 24% de tasa de respuesta global y un 71% de tasa de control de la enfermedad, con reducción tumoral en el 41% de los pacientes. Ambos grupos de pacientes demostraron efectos secundarios manejables. Un análisis post-hoc reveló que los pacientes con mayor exposición a AFM24 tenían resultados significativamente mejores, lo que llevó a planes de usar una dosis semanal más alta de 720 mg en el desarrollo futuro.
Affimed (AFMD)는 비소세포 폐암(NSCLC) 환자에서 AFM24와 아테졸리주맙을 결합한 AFM24-102 시험의 긍정적인 임상 데이터를 보고했습니다. EGFR 와일드 타입 환자 33명에서 이 조합은 21%의 전체 반응률과 76%의 질병 조절률을 보였으며, 환자의 48%에서 종양 크기가 줄어들었습니다. 무진행 생존 기간의 중앙값은 5.6개월이었습니다.
EGFR 돌연변이 환자 17명에서의 결과는 24%의 전체 반응률와 71%의 질병 조절률을 보였으며, 환자의 41%에서 종양 크기가 줄어들었습니다. 두 환자 집단 모두 관리 가능한 부작용을 나타냈습니다. 사후 분석 결과, AFM24 노출이 더 높은 환자들이 유의미하게 더 나은 결과를 보여, 향후 개발에 있어 주당 720mg의 더 높은 용량을 사용할 계획이 세워졌습니다.
Affimed (AFMD) a rapporté des données cliniques positives de l'essai AFM24-102 combinant AFM24 avec l'atezolizumab chez des patients atteints de cancer du poumon non à petites cellules (NSCLC). Dans 33 patients avec un type sauvage d'EGFR, la combinaison a montré un 21% de taux de réponse global et un 76% de taux de contrôle de la maladie, avec une réduction tumorale chez 48% des patients. La médiane de survie sans progression était de 5,6 mois.
Chez 17 patients porteurs d'une mutation d'EGFR, les résultats ont montré un 24% de taux de réponse global et un 71% de taux de contrôle de la maladie, avec une réduction tumorale chez 41% des patients. Les deux groupes de patients ont montré des effets secondaires gérables. Une analyse post-hoc a révélé que les patients ayant une exposition plus élevée à l'AFM24 avaient des résultats significativement meilleurs, ce qui a conduit à des projets d'utiliser une dose hebdomadaire plus élevée de 720 mg dans le développement futur.
Affimed (AFMD) berichtete über positive klinische Daten aus der AFM24-102-Studie, die AFM24 mit Atezolizumab bei Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) kombiniert. Bei 33 EGFR-Wildtyp-Patienten zeigte die Kombination eine 21% Gesamtansprechenquote und eine 76% Krankheitskontrollrate, mit Tumorverkleinerung bei 48% der Patienten. Das mediane progressionsfreie Überleben betrug 5,6 Monate.
Bei 17 EGFR-mutierten Patienten zeigten die Ergebnisse eine 24% Gesamtansprechenquote und eine 71% Krankheitskontrollrate, mit Tumorverkleinerung bei 41% der Patienten. Beide Patientengruppen wiesen handhabbare Nebenwirkungen auf. Eine Post-hoc-Analyse ergab, dass Patienten mit höherer AFM24-Exposition signifikant bessere Ergebnisse hatten, was zu Plänen für die Verwendung einer höheren wöchentlichen Dosis von 720 mg in der zukünftigen Entwicklung führte.
- 21% overall response rate in EGFR wild-type NSCLC patients
- 24% overall response rate in EGFR mutant NSCLC patients
- 76% disease control rate in wild-type patients
- 5.6 months median progression-free survival in both cohorts
- Higher AFM24 exposure linked to better patient outcomes
- Well-manageable safety profile with no new safety concerns
- Only 36% of wild-type patients remain on treatment
- sample size with only 33 wild-type and 17 mutant patients evaluated
Insights
- In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate (ORR) of
21% (6 confirmed responses, 1 response awaiting confirmatory scan) and a disease control rate (DCR) of76% ; tumor shrinkage was observed in48% of patients; preliminary median progression free survival (PFS) is 5.6 months and36% of patients remain on treatment - In 17 heavily pretreated NSCLC EGFR mutant (EGFRmut) patients the combination shows an ORR of
24% and a DCR of71% ; tumor shrinkage was observed in41% of patients; median PFS is 5.6 months and 5 patients (29% ) are on treatment for over 10 months - Both cohorts demonstrated a well-manageable side effect profile with no new safety signals identified
- A post hoc analysis demonstrated that patients who achieve higher exposure of AFM24 had significantly higher response rates and improved PFS and survival compared to patients with lower exposure
- Company to review results on a webcast today at 8:30 am EST / 14:30 CET
MANNHEIM, Germany, Dec. 17, 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 updated clinical data from the ongoing AFM24-102 trial of AFM24/atezolizumab combination therapy in heavily pretreated NSCLC patients. Results continue to demonstrate meaningful clinical activity in both NSCLC EGFRwt and EGFRmut patients with good tolerability. In addition, the Company reported findings from a post-hoc exposure-response analysis in patients treated with 480 mg AFM24 showing higher AFM24 exposure is associated with significantly better response rates, improved PFS and overall survival (OS). Based on these data, the future development program for AFM24 will use a dose of 720 mg weekly, a dose that has already been successfully tested in the phase 1 study of AFM24 showing a manageable safety profile.
“With the compelling data from both EGFR wild-type and mutant cohorts, along with the exposure-response analysis we are unlocking the possibilities for the AFM24/atezolizumab combination in treating heavily pretreated NSCLC patients,” said Dr. Shawn Leland, PharmD, RPh, Chief Executive Officer of Affimed. “These findings highlight our opportunity to further refine and advance this treatment with a clear focus on patients who stand to benefit the most. We are excited about the path ahead and are committed to exploring innovative strategies to bring this promising therapy to those in need.”
NSCLC EGFR Wild-type Cohort Update
Patient population: As of the November 14, 2024 data cut, there were 43 patients in the full analysis set (FAS) and 33 patients in the per protocol set (PPS), defined as having one post baseline scan according to RECIST. Reasons for non-evaluability were early symptomatic deterioration (6), non-related AEs (2), too early (2). Patients had a median of 2 prior lines of therapy (range: 1–7). All patients had received platinum-based combinations and PD(L) 1 targeting checkpoint inhibitors (CPIs), and two-thirds had received taxanes. Importantly, all but one patient discontinued their previous CPI because of progression.
Safety: The AFM24 and atezolizumab combination therapy was well tolerated with no unexpected safety findings. Infusion related reactions (IRRs) were the most common adverse event (AE) reported, in
Anti-tumor activity and durability (N=33, PPS): The combination demonstrated an ORR of
NSCLC EGFR Mutant Cohort Update
Patient population: As of the November 14, 2024 data cut, 28 patients were in the FAS (reasons for non-evaluability at the cut-off were: ongoing with no scan yet 5, early deterioration 4, non-related AEs 2), with updated results presented for the first 17 patients in the PPS. All patients had received prior EGFR specific TKI therapy, and
Anti-tumor activity and durability (N=17, PPS): AFM24 combined with atezolizumab showed promising activity in refractory NSCLC EGFRmut patients achieving an ORR of
Post-Hoc Exposure-Response Analysis
Analysis process: A post-hoc exposure-response analysis was conducted including NSCLC EGFRwt and EGFRmut subjects (n= 44) treated with 480 mg AFM24 in both the AFM24-101 monotherapy study or the AFM24-102 AFM24 combination with atezolizumab study. Low and high exposure groups were calculated using a median cut-point of patient`s mean trough values.
Safety, anti-tumor activity and durability: Baseline characteristics were balanced between the high and low exposure groups and there were no differences in body mass index or percentage of administered dose that would explain differences in exposure. The high exposure group showed an ORR of
“Advanced-stage NSCLC remains one of the most challenging cancers to treat, and our findings bring new hope,” said Dr. Andreas Harstrick, MD, Chief Medical Officer of Affimed. “We see compelling efficacy results with the AFM24/atezolizumab combination in heavily pretreated NSCLC patients, independent from the mutational status. The results are remarkable as we achieve this with a purely immunotherapy-based approach in patients that are often not able or not willing to take additional toxic therapies. The insights in the relation of exposure and efficacy will allow us to further improve on the efficacy and provide a clear path forward as we strive to unlock new possibilities for EGFR NSCLC patients.”
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.
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 preclinical development and clinical trials; 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
What are the response rates for AFM24/atezolizumab in NSCLC patients?
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What is the new planned dosage for AFM24 based on the exposure-response analysis?
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How many NSCLC patients achieved tumor shrinkage with AFMD's combination therapy?
