Arrivent Presents the Final Analysis of Firmonertinib Monotherapy Data from Global Phase 1b Study in EGFR PACC Mutant Non-Small Cell Lung Cancer at the 2025 World Conference on Lung Cancer
ArriVent BioPharma (NASDAQ:AVBP) presented final proof-of-concept data from its global Phase 1b FURTHER trial for firmonertinib in EGFR PACC mutant non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer. The study demonstrated significant efficacy with 16.0 months median progression-free survival and a 68.2% confirmed overall response rate at 240mg dosing.
Key highlights include 14.6 months median duration of response, confirmed CNS responses with complete responses, and rapid clearance of PACC circulating tumor DNA in 82% of frontline patients at 240mg. The drug showed broad activity across various PACC mutations and maintained a manageable safety profile consistent with EGFR-TKI class drugs. ArriVent plans to initiate the global Phase 3 ALPACCA study in the second half of 2025.
ArriVent BioPharma (NASDAQ:AVBP) ha presentato i dati finali di proof-of-concept del trial globale di Fase 1b FURTHER su firmonertinib per il NSCLC con mutazione PACC di EGFR alla World Conference on Lung Cancer 2025. Lo studio ha evidenziato un’efficacia significativa con una sopravvivenza libera da progressione mediana di 16,0 mesi e un tasso di risposta globale confermato del 68,2% con dosaggio a 240 mg.
Tra i punti salienti: durata mediana della risposta di 14,6 mesi, risposte confermate nel sistema nervoso centrale, comprese remissioni complete, e rapida scomparsa del DNA tumorale circolante PACC nel 82% dei pazienti in prima linea a 240 mg. Il farmaco ha mostrato attività su diverse varianti PACC e un profilo di sicurezza gestibile, coerente con la classe degli EGFR-TKI. ArriVent prevede di avviare lo studio globale di Fase 3 ALPACCA nella seconda metà del 2025.
ArriVent BioPharma (NASDAQ:AVBP) presentó los datos finales de prueba de concepto del ensayo global de fase 1b FURTHER con firmonertinib en NSCLC con mutación PACC de EGFR en la World Conference on Lung Cancer 2025. El estudio mostró eficacia significativa con una mediana de supervivencia libre de progresión de 16,0 meses y una tasa de respuesta global confirmada del 68,2% con la dosis de 240 mg.
Entre los aspectos destacados figuran una duración media de la respuesta de 14,6 meses, respuestas confirmadas en el sistema nervioso central, incluidas respuestas completas, y una rápida eliminación del ADN tumoral circulante PACC en el 82% de los pacientes de primera línea a 240 mg. El fármaco mostró actividad frente a diversas mutaciones PACC y un perfil de seguridad manejable, coherente con los inhibidores de EGFR (EGFR-TKI). ArriVent planea iniciar el estudio global de fase 3 ALPACCA en la segunda mitad de 2025.
ArriVent BioPharma (NASDAQ:AVBP)는 2025년 세계폐암학회에서 EGFR PACC 돌연변이 비소세포폐암(NSCLC) 치료제 firmonertinib의 글로벌 1b상 FURTHER 시험 최종 개념증명 결과를 발표했습니다. 연구 결과 240mg 투여군에서 무진행생존 중앙값 16.0개월과 확인된 전체 반응률 68.2%로 유의한 효능을 보였습니다.
주요 내용으로는 반응 지속기간 중앙값 14.6개월, 중추신경계(CNS)에서의 확인된 반응(완전 관해 포함), 그리고 240mg 투여 시 1차 치료 환자의 82%에서 PACC 순환종양DNA의 빠른 소실이 보고되었습니다. 약물은 다양한 PACC 변이에서 광범위한 효능을 보였고, EGFR-TKI 계열과 일치하는 관리 가능한 안전성 프로파일을 유지했습니다. ArriVent는 2025년 하반기에 글로벌 3상 ALPACCA 시험을 개시할 계획입니다.
ArriVent BioPharma (NASDAQ:AVBP) a présenté les données finales de preuve de concept de l'essai mondial de phase 1b FURTHER sur le firmonertinib dans le cancer du poumon non à petites cellules (NSCLC) mutant PACC d'EGFR lors de la World Conference on Lung Cancer 2025. L'étude a montré une efficacité significative avec une survie sans progression médiane de 16,0 mois et un taux de réponse globale confirmé de 68,2% à la dose de 240 mg.
Points clés : durée médiane de la réponse de 14,6 mois, réponses confirmées au niveau du système nerveux central, y compris des réponses complètes, et clairance rapide de l'ADN tumoral circulant PACC chez 82% des patients en première ligne à 240 mg. Le médicament a montré une activité étendue sur diverses mutations PACC et un profil de sécurité gérable, conforme à la classe des EGFR-TKI. ArriVent prévoit de lancer l'étude mondiale de phase 3 ALPACCA dans la seconde moitié de 2025.
ArriVent BioPharma (NASDAQ:AVBP) stellte auf der World Conference on Lung Cancer 2025 die abschließenden Proof-of-Concept-Daten der globalen Phase-1b-Studie FURTHER zu firmonertinib bei EGFR PACC-mutiertem nicht-kleinzelligem Lungenkrebs (NSCLC) vor. Die Studie zeigte eine signifikante Wirksamkeit mit einem medianen progressionsfreien Überleben von 16,0 Monaten und eine bestätigte objektive Ansprechrate von 68,2% bei 240 mg Dosierung.
Wesentliche Ergebnisse sind eine mittlere Ansprechdauer von 14,6 Monaten, bestätigte ZNS-Ansprechen einschließlich kompletter Remissionen sowie ein rasches Verschwinden des zirkulierenden PACC-Tumor-DNA bei 82% der Erstlinientherapie-Patienten unter 240 mg. Der Wirkstoff zeigte Aktivität gegen verschiedene PACC-Mutationen und ein handhabbares Sicherheitsprofil, das mit der EGFR-TKI-Klasse übereinstimmt. ArriVent plant, die globale Phase-3-Studie ALPACCA in der zweiten Hälfte 2025 zu starten.
- Strong efficacy with 16.0 months median progression-free survival in first-line patients
- High response rate of 68.2% confirmed ORR at 240mg dosing
- Impressive 82% ctDNA clearance rate in frontline PACC patients at 240mg
- Demonstrated CNS efficacy with 42.9% confirmed response rate and 35.7% complete responses
- Generally well-tolerated safety profile consistent with EGFR-TKI class
- Most common treatment-related adverse events include diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin
Insights
ArriVent's firmonertinib shows impressive 16-month PFS and 68.2% response rate in EGFR PACC mutant NSCLC, indicating strong potential as first-line therapy.
The final analysis of the Phase 1b FURTHER trial presents remarkably strong efficacy data for firmonertinib in EGFR PACC-mutated non-small cell lung cancer. The 16.0-month median progression-free survival in first-line patients is particularly noteworthy when compared to historical outcomes for this mutation subtype. Traditional EGFR inhibitors typically show limited efficacy against PACC mutations, making these results potentially practice-changing.
The 68.2% confirmed overall response rate at the 240mg dose demonstrates robust anti-tumor activity, with most patients responding at their first assessment. The 14.6-month duration of response further suggests durable benefit, addressing a critical need for sustained disease control.
Especially significant is the 42.9% CNS response rate with 35.7% complete responses in brain metastases, an area where many targeted therapies struggle. This brain penetrance could differentiate firmonertinib from competitors and address a crucial unmet need, as CNS progression often limits long-term outcomes.
The ctDNA clearance rates of 82% at the 240mg dose indicate rapid and profound molecular responses across diverse PACC mutations (frequent, less frequent, and compound), suggesting broad activity throughout this mutation subtype. This molecular response pattern correlates well with the observed clinical efficacy.
The safety profile appears consistent with other EGFR inhibitors, with manageable toxicities even with extended treatment. With the advancement to a pivotal Phase 3 trial (ALPACCA), firmonertinib shows significant potential to address the current treatment gap for this specific molecular subtype of NSCLC.
- 16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients
- Confirmed overall response rate (cORR)
68.2% and duration of response (DOR) 14.6 months by BICR in first-line patients - Confirmed CNS (central nervous system) responses with firmonertinib including complete responses (CRs) by BICR
- Firmonertinib rapidly decreased or cleared PACC circulating tumor DNA (ctDNA) in frontline patients across PACC mutation types (frequent, less frequent and compound PACC) consistent with broad PACC activity
- Enrollment of the first patient in the global pivotal Phase 3 ALPACCA study in first-line EGFR PACC mutant non-small cell lung (NSCLC) cancer expected in the second half of 2025
NEWTOWN SQUARE, Pa., Sept. 09, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today presented positive final proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations at the IASCLC 2025 annual World Conference on Lung Cancer (WCLC), in Barcelona, Spain.
“Our 16-month prolonged progression free survival with once daily oral firmonertinib monotherapy has been maintained with 16.5 months of median follow up and we are particularly encouraged by the CNS responses including CNS complete responses” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “Together this data reinforces the potential of firmonertinib to address key unmet needs in the global EGFR mutant NSCLC treatment landscape. Additionally, the rapid clearance of PACC ctDNA in frontline patients observed across a broad range of PACC mutations, including those with frequent, less frequent and compound PACC mutations, is consistent with the broad activity of firmonertinib in PACC mutant NSCLC. We expect to enroll the first patient in our global registrational ALPACCA Phase 3 trial in frontline PACC patients in the second half of the year.”
Key Highlights of Longer-term Final Analysis Data for Firmonertinib Monotherapy:
- Maintained Clinically Meaningful PFS and Durable Responses
- 16.0 months mPFS with firmonertinib once daily 240 mg by BICR, with majority of patients remaining on study
- 14.6 months median duration of response with firmonertinib 240 mg by BICR
68.2% and43.5% confirmed ORR by BICR at 240 mg and 160 mg, respectively- Confirmed responses at first tumor assessment in the majority of patients
- Responses across a wide range of EGFR PACC mutations including most frequent (G719X, S768I), less frequent (E709X, V774M) and compound mutations
42.9% (6/14) CNS confirmed ORR and35.7% (5/14) CNS confirmed CRs in CNS evaluable disease front-line patients by BICR
- Safety Profile Continues to be Consistent with No New Safety Signals
- Generally well-tolerated and manageable safety profile maintained over longer treatment duration
- Most frequent treatment-related adverse events include diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin
- No new safety findings with further follow up and safety profile remains consistent with EGFR-TKI class
- Rapidly Decreased or Cleared PACC ctDNA in Frontline Patients
82% (9/11) and79% (11/14) ctDNA clearance in frontline PACC patients treated with firmonertinib at 240 mg and 160 mg, respectively, in patients with detectable PACC ctDNA at baseline- Consistent decreases in ctDNA across different PACC mutations were observed including in patients with frequent, less frequent and compound mutations
About ArriVent
ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development, and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization.
About Firmonertinib
Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations.
Firmonertinib was granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for the treatment of patients with previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. Firmonertinib was also granted U.S. FDA Orphan Drug Designation for the treatment of NSCLC with EGFR mutations or human epidermal growth factor receptor 2 (HER2) mutations or HER4 mutations.
Firmonertinib is currently being studied in a global Phase 3 trial for first-line NSCLC patients with EGFR exon 20 insertion mutations (FURVENT; NCT05607550) and in a global Phase 3 study in first line NSCLC patients with EGFR PACC mutations (ALPACCA). In addition, firmonertinib is also being studied in a clinical combination study targeting advanced or metastatic NSCLC patients with EGFR classical mutations, in partnership with Beijing InnoCare Pharma Tech Co., Ltd.
About EGFR mutant NSCLC
Globally, lung cancer is the leading cause of cancer-related deaths among men and women. NSCLC is the predominant subtype of lung cancer, accounting for approximately
About EGFR PACC mutations
P-loop and αC-helix compressing (PACC) EGFR mutations are a distinct set of approximately 70 mostly missense activating mutations within the kinase domain of EGFR. They are similar to Exon 20 insertion mutations in narrowing the drug binding pocket to affect tyrosine kinase inhibitor activity. PACC mutations are diagnosed through commercially available NGS and most PCR tests. Patients with PACC mutations have limited treatment options, and there is no broadly utilized standard of care treatment for first-line PACC mutant patients.
About FURVENT
FURVENT is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China. Topline data expected in early 2026. An interim analysis for this study has not been performed and there is no plan to perform such analysis.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans, cash runway, estimates of our addressable market, activity of firmonertinib compared to available therapies, duration of firmonertinib therapy in NSCLC patient populations, anticipated clinical milestones, the timing of, and results of, top-line pivotal Phase 3 data for firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR exon 20 insertion mutations, the timing of potential enrollment of the first patient in the global pivotal Phase 3 ALPACCA study of firmonertinib in previously untreated NSCLC patients whose tumors contain EGFR PACC mutations, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on ArriVent’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our annual report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on March 3, 2025 and our other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and ArriVent undertakes no duty to update such information except as required under applicable law.
Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
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