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    DRUG:

    Ameile (aumolertinib)

    i
    Other names: HS-10296, HS 10296, EQ143, EQ-143, EQ 143, HS10296
    Company:
    Abdul Latif Jameel Health, Glenmark, Jiangsu Hansoh Pharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    10d
    First-line Aumolertinib (EGFR tyrosine kinase inhibitor) plus apatinib (VEGFR inhibitor) versus aumolertinib in EGFR-mutant non-small cell lung cancer patients: a randomized, multicenter, phase II trial. (PubMed, Signal Transduct Target Ther)
    Exploratory analysis revealed that PFS benefits from aumolertinib plus apatinib predominantly in those with TP53 mutations. As an infusion-free option, aumolertinib plus apatinib demonstrated PFS benefits with manageable safety in patients with untreated, EGFR-mutant, advanced NSCLC.
    Clinical • P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
    |
    TP53 mutation • EGFR mutation
    |
    AiTan (rivoceranib) • Ameile (aumolertinib)
    11d
    A Case of Refractory Pulmonary Enteric Adenocarcinoma with EGFR Sensitive Mutation (PubMed, Zhongguo Fei Ai Za Zhi)
    The patient showed no meaningful response to EGFR-tyrosine kinase inhibitors (EGFR-TKIs), including the first-generation (Icotinib), the second-generation (Afatinib) and the third-generation (Aumolertinib). Trophoblast cell surface antigen 2-antibody-drug conjugate (TROP2-ADC) and immune checkpoint inhibitors (ICIs) combined with Bevacizumab also resulted in limited efficacy. Based on the clinical features and treatment response of this case, we reviewed the published literature about the pathological characteristics, mutational landscape, and current therapeutic approaches for PEAC, with a particular focus on the therapeutic challenges and future research directions for EGFR-mutant PEAC, aiming to provide insights for clinical practice and further studies..
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR mutation • EGFR exon 19 deletion
    |
    Avastin (bevacizumab) • Gilotrif (afatinib) • Conmana (icotinib) • Ameile (aumolertinib)
    12d
    A study evaluating the efficacy and safety of aumolertinib mesylate as first-line therapy in patients with EGFR-mutated stage IIIB-IV non-squamous non-small cell lung cancer (NSCLC) complicated by chronic obstructive pulmonary disease (COPD) (ChiCTR2600117077)
    P=N/A, N=51, Not yet recruiting, Tianjin Chest Hospital; Tianjin Chest Hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Ameile (aumolertinib)
    12d
    Exploration of the Efficacy and Safety of metronomic chemotherapy with vinorelbine capsules combined with third-generation EGFR-TKI as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations (ChiCTR2500115674)
    P=N/A, N=66, Not yet recruiting, Beijing hospital; Beijing hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib) • vinorelbine tartrate • Ivesa (firmonertinib) • simmitinib (SYHA1817)
    12d
    A Single-Arm, Open-Label Clinical Study of Aumolertinib Monotherapy as Long-Cycle Neoadjuvant Treatment for Stage IB-ⅢB EGFR-Positive Non-Small Cell Lung Cancer (ChiCTR2500115235)
    P=N/A, N=30, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    12d
    Exploration of the Exposure Level of Aumolertinib and Its Correlation with Clinical Efficacy in Patients with Lung Cancer (ChiCTR2500114329)
    P=N/A, N=50, Not yet recruiting, Shanghai General Hospital; Shanghai General Hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Ameile (aumolertinib)
    12d
    Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star) (ChiCTR2500115167)
    P4, N=598, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital
    New P4 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR L858R • EGFR T790M • ALK mutation
    |
    carboplatin • albumin-bound paclitaxel • pemetrexed • Ensacove (ensartinib) • Ameile (aumolertinib) • AiRuiLi (adebrelimab)
    12d
    Almonertinib plus Anlotinib for EGFR Mutant NSCLC with Progression After Third-Generation TKI Adjuvant Therapy (ChiCTR2500114326)
    P4, N=50, Recruiting, Tianjin Medical University Cancer Institute&Hospital; Tianjin Medical University Cancer Institute&Hospital
    New P4 trial
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Focus V (anlotinib) • Ameile (aumolertinib)
    12d
    An Open-Label, Single-Arm, Exploratory Phase Ⅱ Clinical Study of Almonertinib Combined with Vinorelbine Tartrate Soft Capsules in the Treatment of Elderly Patients with Advanced NSCLC Progressed after Third-Generation EGFR-TKI Therapy (ChiCTR2600116503)
    P2, N=100, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital; Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ameile (aumolertinib) • vinorelbine tartrate
    12d
    Prospective Phase II Single-Arm Study of Induction Therapy with Aumolertinib and Chemotherapy in Potentially Resectable Stage Ⅲ EGFR-Mutant Non-Squamous NSCLC (ChiCTR2600117161)
    P2, N=20, Not yet recruiting, Sichuan Cancer Hospital; Sichuan Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    carboplatin • pemetrexed • Ameile (aumolertinib)
    27d
    Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol)
    Aumolertinib showed substantial clinical benefits as adjuvant therapy in Chinese patients with stage II-IIIB EGFR-mutated NSCLC. The manageable safety profile of aumolertinib supports its suitability in the adjuvant setting.
    P3 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 19 deletion
    |
    Ameile (aumolertinib)
    1m
    A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. (PubMed, Transl Lung Cancer Res)
    Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Ameile (aumolertinib) • izalontamab brengitecan (BL-B01D1)