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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:
1d
Germ-line exon 21 EGFR V831H mutation in advanced NSCLC resistance to almonertinib: a case report. (PubMed, Front Oncol)
The rapid progression suggests that this specific germ-line variant may confer inherent TKI resistance, potentially exacerbated by the presence of a concurrent KRAS G12V mutation and drug-drug interactions between almonertinib and antituberculosis medications. It underscores the clinical challenge of germ-line EGFR mutations and emphasizes the need for further research to establish effective therapeutic strategies for such rare genotypes.
Journal
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
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KRAS mutation • EGFR mutation • KRAS G12
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Ameile (aumolertinib)
10d
Epidermal growth factor receptor tyrosine kinase inhibitor for the treatment of non-small cell lung cancer in the past 30 years (1997-2026). (PubMed, Chin Med J (Engl))
Since 1997, EGFR tyrosine kinase inhibitors (EGFR-TKIs) have evolved from first-generation agents, such as gefitinib, erlotinib, and icotinib, to second-generation agents like afatinib and dacomitinib, now to third-generation agents, including osimertinib, aumolertinib, furmonertinib, befotertinib, rezivertinib, rilertinib, limertinib, lazertinib, mifanertinib for EGFR L858R, sunvozertinib for EGFR exon 20 insertion (20ins), and zorifertinib for EGFR-sensitive mutation with brain metastases. Over the past 30 years, substantial advancements have been made in the comprehensive management of EGFR-mutant NSCLC. This systemic review provides the history of the development of EGFR-TKI therapy for NSCLC from 1997 to 2026, highlighting clinical milestones, emerging therapies, and future directions in this rapidly evolving field.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR L858R • EGFR exon 20 insertion • EGFR exon 20 mutation
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Tagrisso (osimertinib) • erlotinib • Gilotrif (afatinib) • gefitinib • Conmana (icotinib) • Ameile (aumolertinib) • Vizimpro (dacomitinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • Semena (befotertinib) • Zegfrovy (sunvozertinib) • Zorifer (zorifertinib) • Rui Bi Da (rezivertinib) • Sanrisso (rilertinib) • limertinib (ASK120067)
12d
Efficacy and Safety of Aumolertinib/Icotinib Combination Therapy for Naive EGFR-Mutant NSCLC Patients with Brain Metastases: A Phase I/II Study. (PubMed, Neuro Oncol)
The combination of aumolertinib and icotinib shows encouraging efficacy and a tolerable safety profile in patients with EGFR-mutant NSCLC and BMs, supporting its potential as a therapeutic option warranting further investigation.
P1/2 data • Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Conmana (icotinib) • Ameile (aumolertinib)
1m
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
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EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
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TP53 mutation • EGFR mutation
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AiTan (rivoceranib) • Ameile (aumolertinib)
1m
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
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
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PD-L1 expression • EGFR mutation • EGFR exon 19 deletion
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Avastin (bevacizumab) • Gilotrif (afatinib) • Conmana (icotinib) • Ameile (aumolertinib)
1m
New trial
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
1m
New trial
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Tagrisso (osimertinib) • Ameile (aumolertinib) • vinorelbine tartrate • Ivesa (firmonertinib) • simmitinib (SYHA1817)
1m
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
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Ameile (aumolertinib)
1m
New trial
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
1m
New P4 trial
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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EGFR mutation • EGFR L858R • EGFR T790M • ALK mutation
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carboplatin • albumin-bound paclitaxel • pemetrexed • Ensacove (ensartinib) • Ameile (aumolertinib) • AiRuiLi (adebrelimab)
1m
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
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Focus V (anlotinib) • Ameile (aumolertinib)
1m
New P2 trial
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Ameile (aumolertinib) • vinorelbine tartrate